DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/04/2026 has been entered.
Response to Arguments
Applicant’s arguments, see “Applicant Arguments/Remarks”, filed 03/04/2026, with respect to the rejections under U.S.C. 112(a) have been fully considered and are persuasive. Therefore, the rejections under U.S.C. 112(a) have been withdrawn.
Applicant’s arguments, see “Applicant Arguments/Remarks”, filed 03/04/2026, with respect to the rejections under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Morley, Cox, Lemonis, and Kersting.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over WO Publication 2016168759 awarded to Morley et al, in view of U.S. Patent Publication 20040054358 awarded to Cox et al, further in view of U.S. Patent Publication 20170319388 awarded to Lemonis et al, and further in view of U.S. Patent Publication 20160058281 awarded to Kersting et al.
Regarding Claims 1, 14, and 17, Morley teaches a method for use in relation to removing a lens of an eye of a patient using a surgical device performing a laser-assisted, phacoemulsification cataract removal procedure (Para. 0117), comprising: at least one memory (116) comprising executable instructions (Para. 0123), at least one processor (118) in data communication with the at least one memory (Para. 0123) and configured to execute the instructions to cause the ophthalmic system to: obtaining pre-operative data for the eye of the patient, the pre-operative data including imaging data associated with the lens of the eye of the patient (Para. 0118); determining a lens density including at least one density contour (Fig. 5, Para. 0116, “An embodiment of the system and methods provides a gradient index modification, which has different void densities placed in nested volumes, as shown in FIG. 5. Thus, there is provided a series of nested shot patterns 2602 and a lens outer surface 2601, with each pattern creating an incrementally different void density in the lens material. For example, if a nominal 25% weighting efficiency was obtained in the most densely treated region, filling that volume with 1 .38 index of aqueous humor, and the remaining region that was 75% lens material of index 1 .42, then the average resultant index of refraction would be 0.25.sup.*1 .38+0.75.sup.*1 .42 or 1.41 , which we see from FIGS. 4A-D, that would restore the gradient from the center to a 2 mm radius, which is most central optical region for visual function”) and a lens shape (Para. 0118, “a biometric imaging system to measure the position and shape of the crystalline lens) based on the imaging data associated with the lens of the patient (Para. 0129); and generating a patient-specific laser-assisted, phacoemulsification cataract removal surgical plan for the patient (Para. 0129), the patient-specific laser-assisted, phacoemulsification cataract removal surgical plan for the patient comprising: recommended, patient-specific laser fragmentation patterns for a laser fragmentation portion of the laser-assisted (Para. 0129, “In embodiments of the system capabilities are present for custom fragmentation based upon the information provided by the biometric system. In an embodiment of the system having the capability for a custom fragmentation, an image processing function analyzes the lens image density and classifies it into one of four categories”), phacoemulsification cataract removal procedure based on the lens density and/or shape of the lens of the eye of the patient (Para. 0129); and recommended, patient-specific phacoemulsification settings for a phacoemulsification portion of the laser-assisted, phacoemulsification cataract removal procedure based, at least in part, on the lens density (Para. 0122), wherein the generating the patient-specific laser-assisted, phacoemulsification cataract removal surgical plan for the patient is based on a computational model trained to optimize phacoemulsification settings and laser fragmentation patterns settings for future laser-assisted, phacoemulsification cataract removal procedures (Para. 0160, “Further, it is contemplated that machine learning may be applied to the information obtained from the planning tables, enabling the machine to optimize both the tables and the procedures. This provides particular advantage where system is being utilized in a population having certain characteristics”), and automatically or in response to a surgeon's confirmation, reconfiguring the device according to the patient-specific laser-assisted, phacoemulsification cataract removal surgical plan (Para. 0128). Morley does not teach wherein the computational model is based on historical patients’ preoperative information and historical patients’ post-operative outcomes, wherein the computational model comprises two separate prediction models to recommend the patient-specific laser fragmentation patterns and phacoemulsification settings, analyzing an intensity of each of a plurality of voxels included in the imaging data to determine the lens density and a lens shape associated with the lens of the patient, or wherein the recommended laser fragmentation patterns are based on a computational model trained to optimize time under suction associated with the fragmentation procedure.
However, in the art of optical surgery planning, Cox teaches the usage of a system that provides one model for collecting historical and post-operative data to a first prediction model to help determine treatment settings (see Fig. 2, showing data 292 and initial diagnostic information 215 being processed in computer 220 to output to planning software 230, Para. 0120), and a second model that takes into account the effect of lens shape and suction applied to the eye to determine a surgical plan (Para. 0068 and Paras. 0072-0073) to improve the final correction outcome for a patient (Para. 0011).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morley by Cox, i.e. by using the dual prediction model taught above in Cox in the system of Morley, for the predictable purpose of optimizing surgical results as taught above in Cox.
Further, Lemonis discloses an analogous device and method for adjusting laser energy based on optical density comprising analyzing pixels to determine optical density from each pixel value of an image of the lens (Paras. 0019, and 0022-0024).
It would have been obvious to one of ordinary skill in the art before the effective filing date to determine the lens density map based on an analysis of the pixels in the imaging data as taught by Lemonis in order to accurately determine the optical density for each portion of the lens.
Further, in the art of imaging prior to laser ophthalmic surgery (abstract, Para. 0011), Kersting teaches a system for optimizing suction ring placement to minimize suction ring time on the eye (Paras. 0005-0011) for the purpose of improving treatment capabilities as “Stress and dehydration of the patient's eye may interfere with the physical and mechanical assumptions for the (laser) treatment” (Para. 0011).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morley by Kersting, i.e. by optimizing a time under suction for the procedure, for the predictable purpose of improving surgical outcomes as disclosed above in Para. 0011 of Kersting.
Regarding Claims 3, 16, 19, Morley modified by Cox, Lemonis, and Kersting makes obvious the method of Claim 1. Morley further teaches determining a type of cataract based on the lens density, wherein generating the laser fragmentation patterns is further based on the type of cataract (Paras. 0122-0124).
Regarding Claim 4, Morley modified by Cox, Lemonis, and Kersting makes obvious the method of Claim 1. Morley further teaches generating one or more laser device settings for the portion of the laser-assisted, phacoemulsification cataract removal (Paras. 0122-0124).
Regarding Claim 5, Morley modified by Cox, Lemonis, and Kersting makes obvious the method of Claim 1. Morley further teaches wherein the one or more device settings comprise a frequency of laser (repetition rate), a power of laser, a speed of laser (pulse width), or a type of laser (Para. 0122-0124).
Regarding Claim 7, Morley modified by Cox, Lemonis, and Kersting makes obvious the method of Claim 1. Morley further teaches generating a total length of fragmentation lines, a total length of time of the procedure, and a total energy used because the determined fragmentation pattern contains all of these characteristics i.e. the pattern requires a length of lines, time and energy to create.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Morley in view of Cox, Lemonis and Kersting as applied to claim 1 above, and further in view of U.S. Patent Publication US 20160331590 awarded to Raksi.
Regarding Claim 6, Morley modified by Cox, Lemonis, and Kersting makes obvious the method of Claim 1. Moley does not teach adjusting fragmentation lines.
Raksi discloses an analogous laser fragmentation of lens tissue comprising a pattern having fragmentation lines (Figs. 4a-b). Figs. 4a-b show an implementation of an ophthalmic surgical procedure, during which laser spots (or bubbles) are generated to form granules, the granules themselves forming a granule array. The laser spots can be generated to form a regular spatial pattern of the granules, as shown in FIG. 4b (Para. 0053). Regularly spaced granules utilize the laser pulses well, since they require a limited amount of laser energy to break up a target region (Para. 0053)
It would have been obvious to one of ordinary skill in the art before the effective filing date to use the method taught by Morley to create patterns with the position and orientation of fragmentation lines, as taught by Raksi, since such patterns require a limited amount of laser energy to break up a target region.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Morley in view of Cox, Lemonis, and Kersting as applied to claim 1 above, and further in view of U.S. Patent Publication 20200163727 awarded to Patton.
Regarding Claim 8, Morley modified by Cox, Lemonis, and Kersting makes obvious the method of Claim 1. Morley does not teach at least one of optimizing a time under suction associated with the laser fragmentation procedure, optimizing a total laser energy expended for the laser fragmentation procedure, optimizing a number of laser spots, optimizing of the total length of laser fragmentation lines, optimizing a time required for phacoemulsification, optimizing a total ultrasonic energy required for phacoemulsification, optimizing a time required to aspirate the lens, optimizing an amount of fluid required for aspiration.
Patton discloses an analogous cataract treatment database and algorithm system comprising optimizing treatment plans for an individual [abstract]. A processor of the system can include a machine learning algorithm that correlates data from various databases and factors in lens density to determine an amount of energy applied, a depth of penetration and a pattern of the ablation or incision (Paras. 0022-0024, 0042, 0050].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Morley to include optimizing the laser fragmentation pattern using machine learning, as taught by Patton, in order to improve/tailor the fragmentation pattern to the individual.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Morley in view of Cox, Lemonis, and Kersting as applied to claim 1 above, and further in view of U.S. Patent Publication 20130158530 awarded to Goldshleger et al.
Regarding Claim 9, Morley modified by Cox, Lemonis, and Kersting makes obvious the method of Claim 1, including a system of using an optimization model to update treatment plans (see the rejection to Claim 1). Morley does not teach wherein data is recorded intra-operatively, input into the aforementioned optimization model, and updates and adjusts the fragmentation patterns of the surgical plan.
Goldshleger discloses an analogous method for cataracts imaging comprising providing essentially live image feedback to a cataract surgical system and a laser controller that operates in essentially real time, with the option of adjusting or modifying the surgical scan patterns during the surgery according to the received feedback imaging information (Para. 0110).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method taught by Morley to collect intra-operative image data while the lens is fragmented and adjust the fragmentation patterns, as taught by Goldshleger, in order to improve the fragmentation pattern by accounting for real time changes in the cataracts.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Morley in view of Cox, Lemonis and Kersting as applied to claim 1 above, and further in view of U.S. Patent Publication 20160073868 awarded to Raymond et al, hereinafter Raymond.
Regarding Claim 10, Morley modified by Cox, Lemonis, and Kersting makes obvious the method according to Claim 1. Morley does not teach wherein the generating is based on maximizing a predicted post-operative survey score based on historical post-operative survey scores.
Raymond discloses an analogous system for cataract surgery planning comprising improving patient outcomes by analyzing and taking into account historical cataract surgery outcome data (Paras. 0254 and 0257).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method taught by Morley to take into account historical outcome data (scoring is arbitrary and could be applied) in order to improve/maximize surgical outcomes.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Morley in view of Cox, Lemonis, and Kersting as applied to claim 1 above, and further in view of U.S. Patent Publication 20210259881 awarded to Gray et al.
Regarding Claims 11-13, Morley modified by Cox, Lemonis, and Kersting makes obvious the method of Claim 1. Morley does not teach identifying targets within the lens to apply ultrasonic energy.
Gray discloses an integrated system for combination laser-phacoemulsification therapies comprising recommending and delivering predetermined laser shot patterns and predetermined phacoemulsification procedures to address conditions of the eye, including cataracts [abstract]. In an embodiment the laser-ultrasound system, and in particular the laser-phaco system is configured so that the therapeutic laser beam can be delivered in a therapeutic laser beam pattern to one or both eyes of the patient, and a phacoemulsification procedure can be performed on one or both eyes of the patient, without the patient or the surgeon having to move, from their relative positions with respect to the laser-phaco system [par. 0113]. A predetermined variable mode is the mode where the control system determines optimum ranges for the ultrasonic therapy, based upon the laser therapy provided, the grade of the cataract, and other information obtained by the system prior to, during and after the laser therapeutic procedure [par. 0165]. The phacoemulsification ultrasound probe delivers energy into the eye that is used to break up the remaining cataractous lens material after laser fragmentation or cutting, to facilitate emulsification and aspiration of the remaining pieces [par. 0166].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Morley to include an ultrasonic probe to apply ultrasonic energy to break up remaining cataractous lens material after laser fragmentation to facilitate emulsification and aspiration, as taught by Gray. It would further have been obvious to one of ordinary skill in the art before the effective filing date to generate phacoemulsification device settings including frequency, power level, duration, rate and/or volume of fluid and pressure of applied fluid based on the properties of the remaining cataractous lens material pieces in order to properly facilitate the aspiration.
Conclusion
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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