DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are presented for examination based on the amended claims in the application filed on January 26, 2026.
Claims 1-20 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to judicial exception, an abstract idea, and it has not been integrated into practical application. The claims further do not recite significantly more than the judicial exception.
Claims 1-3, 6-7, 9-13, 16-17, and 19-20 are rejected under 35 U.S.C. § 103 as being unpatentable over US 2018/0098812 A1 Ootsuki, Tomoyuki Kanagawa in view of US 2022/0096274 A1 Fu, Hong et al.
Claims 4-5 and 14-15 are rejected under 35 U.S.C. § 103 as being unpatentable over Ootsuki and Fu as applied to claim 1 above, and further in view of Aaron, Maria M., Sherleen Chen, James A. Davison, A. Tim Johnson, and Kevin M. Miller. “Complex Case Management: Choice of IOL After an Anterior Capsular Tear.” CATARACT & REFRACTIVE SURGERY TODAY, pp. 43-46. June 2011.
Claims 8 and 18 are rejected under 35 U.S.C. § 103 as being unpatentable over Ootsuki and Fu as applied to claim 7 above, and further in view of Aaron, and in further view of US 2019/0357980 A1 Andrews, Delbert Peter.
This action is made Final.
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 .
Response to Amendment
The amendment filed January 26, 2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed November 7, 2025.
Claim Rejections - 35 U.S.C. § 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 1-20 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to judicial exception, an abstract idea, and it has not been integrated into practical application. The claims further do not recite significantly more than the judicial exception. Examiner has evaluated the claims under the framework provided in the 2019 Patent Eligibility Guidance published in the Federal Register 01/07/2019 and has provided such analysis below.
Step 1:
Claims 1-10 are directed to a method and fall within the statutory category of a process, and claims 11-20 are directed to a system and fall within the statutory category of a machine. Therefore, “Are the claims to a process, machine, manufacture or composition of matter?” Yes.
In order to evaluate the Step 2A inquiry “Is the claim directed to a law of nature, a natural phenomenon or an abstract idea?” we must determine, at Step 2A Prong 1, whether the claim recites a law of nature, a natural phenomenon or an abstract idea and further whether the claim recites additional elements that integrate the judicial exception into a practical application.
Step 2A Prong 1:
Claims 1 and 11: The limitations of
“initiating registration of the one or more live images with respect to the pre-operative image” and “initiating registration of the live video with respect to the pre-operative image”;
“initiating presentation of one or more first steps of the primary treatment plan, the one or more first steps defining superimposition of one or more first guides on the one or more live images” and “initiating presentation of one or more first steps of the primary treatment plan, the one or more first steps defining superimposition of one or more first guides on the live video”; and
“in response to the instruction, initiating, presentation of one or more second steps of the backup treatment plan, the one or more second steps defining superimposition of one or more second guides on the one or more live images, the one or more second guides being different from the one or more first guides” and “in response to the instruction, initiating, presentation of one or more second steps of the backup treatment plan, the one or more second steps defining superimposition of one or more second guides on live video, the one or more second guides being different from the one or more first guides”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, the limitation can be performed as the following:
a person can mentally determine or draw with pen and paper how a frame of a captured video feed of a patient’s eye correlates to given pre-operative image of the patent by determining the orientation of the frame and rotate the frame to match the orientation of the pre-operative image,
a person can mentally modify or draw with pen and paper frame of a captured video feed of a patient’s eye by indicating the location of an incision of the eye for a primary surgery on the frame, and
a person can mentally modify or draw with pen and paper frame of a captured video feed of a patient’s eye by indicating the location of an intraocular lens (IOL) axis with respect the eye orientation for a backup surgery on the frame.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Therefore, yes, claims 1 and 11 recite judicial exceptions. The claims have been identified to recite judicial exceptions, Step 2A Prong 2 will evaluate whether the claims are directed to the judicial exception.
Step 2A Prong 2:
Claims 1 and 11: The judicial exception is not integrated into a practical application. In particular, the claims recite the following additional elements: “by the computing device”, “by the computing device, on a display device coupled to the computing device”, and “by the computing device, on the display device”, and “A system for guiding ophthalmic surgery comprising: one or more processing devices; and one or more memory devices coupled to the one or more processing devices and storing executable code that, when executed by the one or more processing devices” which is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) with the broadest reasonable interpretation, which does not integrate a judicial exception into elements. Further, the following additional elements of “loading, by a computing device, a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom, having a common pre-operative image of a patient”, “receiving one or more live images of an eye of the patient”, “receiving an instruction to switch to a second plan of the two or more treatment plans”, and “receive a live video of an eye of the patient” which is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) and/or a recitation of insignificant extra-solution activities (see MPEP § 2106.05(g)) which does not integrate a judicial exception into practical application. The insignificant extra-solution activities are further addressed below under step 2B as also being Well-Understood, Routine, and Conventional (WURC).
Therefore, “Do the claims recite additional elements that integrate the judicial exception into a practical application?” No, these additional elements do not integrate the abstract idea into a practical application and they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
After having evaluated the inquires set forth in Steps 2A Prong 1 and 2, it has been concluded that claims 1 and 11 not only recite a judicial exception but that the claims are directed to the judicial exception as the judicial exception has not been integrated into practical application.
Step 2B:
Claims 1 and 11: The claims do not include additional elements, alone or in combination, that are 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 elements amount to no more than generic computing components which do not amount to significantly more than the abstract idea. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”).
Therefore, “Do the claims recite additional elements that amount to significantly more than the judicial exception?” No, these additional elements, alone or in combination, do not amount to significantly more than the judicial exception. Having concluded the analysis within the provided framework, claims 1 and 11 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claims 2 and 12, they recite an additional limitation of “(a) determining that a portion of the one or more second steps are compatible with a portion of the one or more first steps presented on the display device prior to receiving the instruction to switch to the backup treatment plan; and in response to (a), omitting presentation of the portion of the one or more second steps”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper that if the any of steps in the backup treatment plan are included in the primary treatment plan, then the duplicated steps are not repeated in the backup treatment plan.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Furthermore, regarding claims 2 and 12, they recite additional element recitations of “by the computing device” and “wherein the executable code when executed by the one or more processing devices further causes the one or more processing device” which is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) which does not integrate a judicial exception into practical application. Further, these claims do not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional elements amount to significantly more, these claims also fail both Step 2A prong 2, thus the claims are directed to the judicial exception as they have not been integrated into practical application, and fail Step 2B as not amounting to significantly more. Therefore, claims 2 and 12 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claims 3 and 13, they recite an additional limitation of “(b) identifying an incompatible step of the one or more second steps that is incompatible with the one or more first steps; and in response to (b), initiating presentation of the one or more second steps with the incompatible step”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper the steps in the backup treatment plan are repetitive in the first treatment plan, then the primary non-repetitive step in the backup treatment will be executed after a previous step executed in the primary treatment prior to a command given to switch from the primary treatment plan to the backup treatment plan.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Furthermore, regarding claims 3 and 13, they recite additional element recitations of “by the computing device” and “wherein the executable code when executed by the one or more processing devices further causes the one or more processing device” which is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) which does not integrate a judicial exception into practical application. Further, these claims do not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional elements amount to significantly more, these claims also fail both Step 2A prong 2, thus the claims are directed to the judicial exception as they have not been integrated into practical application, and fail Step 2B as not amounting to significantly more. Therefore, claims 3 and 13 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claims 4 and 14, they recite an additional limitation of “wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) and the backup treatment plan corresponds to placement of a non-toric IOL”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally modify or draw with pen and paper frame of a captured video feed of a patient’s eye by indicating the location of an incision of the eye on the frame for a primary surgery to include the placement of a toric intraocular lens (IOL), and a person can mentally modify or draw with pen and paper frame of a captured video feed of a patient’s eye by indicating the location of an intraocular lens (IOL) axis with respect the eye orientation on the frame for backup surgery to include the placement of a non-toric intraocular lens (IOL).
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claims 5 and 15, they recite an additional limitation of “wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) in a capsular bag of the eye of the patient and the backup treatment plan corresponds to sulcus placement of a non-toric IOL”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally modify or draw with pen and paper frame of a captured video feed of a patient’s eye by indicating the location of an incision of the eye on the frame for a primary surgery to include the placement of a toric intraocular lens (IOL) in a capsular bag of the eye of the patient, and a person can mentally modify or draw with pen and paper frame of a captured video feed of a patient’s eye by indicating the location of an intraocular lens (IOL) axis with respect the eye orientation on the frame for a backup surgery to include the sulcus placement of a non-toric intraocular lens (IOL).
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claims 6 and 16, they recite an additional limitation of “wherein the one or more first steps include an incision step, a removal step corresponding to removal of a crystalline lens of the eye of the patient, a centration step of an intraocular lens (IOL), and an alignment step of an IOL axis of the IOL”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally modify or draw with pen and paper frame of a captured video feed of a patient’s eye by indicating the location of an incision of the eye for a surgery, removing the crystalline lens, inserting and aligning the intraocular lens (IOL), and including these steps in sequential frames.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claims 7 and 17, they recite an additional limitation of “wherein the one or more first steps comprise a plurality of first steps”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally modify or draw with pen and paper frame of a captured video feed of a patient’s eye by indicating the location of an incision of the eye for a surgery, removing the crystalline lens, inserting and aligning the intraocular lens (IOL), and including these steps in sequential frames.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Furthermore, regarding claims 7 and 17, they recite additional element recitations of “by the computing device” and “wherein the executable code when executed by the one or more processing devices further causes the one or more processing device” which is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) which does not integrate a judicial exception into practical application. Further, they recite an additional element recitation of “receiving the instruction to switch to the backup plan prior to completing presentation of all steps of the plurality of first steps” which is an insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”). Further, these claims do not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional elements amount to significantly more, these claims also fail both Step 2A prong 2, thus the claims are directed to the judicial exception as they have not been integrated into practical application, and fail Step 2B as not amounting to significantly more. Therefore, claims 7 and 17 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claims 8 and 18, they recite an additional element recitation of “performing a second post-operative data collection step included in the one or more second steps and omitting performance of a first post-operative data collection step included in the one or more first steps” which is merely an insignificant extra-solution activity (see MPEP § 2106.05(g)) which does not integrate a judicial exception into practical application. Further, they cite additional element recitations of “by the computing device” and “wherein the executable code when executed by the one or more processing devices further causes the one or more processing device” which is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) which does not integrate a judicial exception into practical application. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”).]Further, these claims do not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional elements amount to significantly more, these claims also fail both Step 2A prong 2, thus the claims are directed to the judicial exception as they have not been integrated into practical application, and fail Step 2B as not amounting to significantly more. Therefore, claims 8 and 18 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claims 9 and 19, they recite an additional limitation of “wherein the one or more first guides include one or more of: an incision indicator; a rhexis guide; a limbal release incision guide (LRI); a centration guide; or an intraocular lens (IOL) axis”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally modify or draw with pen and paper frame of a captured video feed of a patient’s eye by indicating the location of an incision of the eye for a surgery on the frame.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claims 10 and 20, they recite an additional limitation of “initiating presentation of the one or more second steps without again initiating registration of the one or more live images with respect to the pre-operative image”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper that if the any of steps in the second treatment plan are included in the first treatment plan then the duplicated steps are not repeated in the second treatment plan, so when a frame of a captured video feed of a patient’s eye correlates to given pre-operative image of the patent by determining the orientation of the frame and rotate the frame to match the orientation of the pre-operative image is done for the first treatment plan, then this step can be omitted for the second treatment plan as it is a repetitive step.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Furthermore, regarding claims 10 and 20, they recite an additional element recitation of “wherein the executable code when executed by the one or more processing devices further causes the one or more processing device” which is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) which does not integrate a judicial exception into practical application. Further, these claims do not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional elements amount to significantly more, these claims also fail both Step 2A prong 2, thus the claims are directed to the judicial exception as they have not been integrated into practical application, and fail Step 2B as not amounting to significantly more. Therefore, claims 10 and 20 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Therefore, having concluded the analysis within the provided framework, claims 1-20 do not recite patent eligible subject matter and are rejected under 35 U.S.C. § 101 because the claimed invention is directed to judicial exception, an abstract idea, that has not been integrated into a practical application. The claims further do not recite significantly more than the judicial exception. Claims 2-10 and 12-20 are also rejected for incorporating the deficiency of their independent claim 1 and 11, respectively.
Claim Rejections - 35 U.S.C. § 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.
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 1-3, 6-7, 9-13, 16-17, and 19-20 are rejected under 35 U.S.C. § 103 as being unpatentable over US 2018/0098812 A1 Ootsuki, Tomoyuki Kanagawa [herein “Ootsuki”] in view of US 2022/0096274 A1 Fu, Hong et al. [herein “Fu”].
As per claim 1, Ootsuki teaches “A method for guiding ophthalmic surgery”. (Para. 0079, “The present technology can be applied to, for example, surgery on a patient's eye. In the case of the following description, cataract surgery is performed on a patient as an example” [e.g., ophthalmic surgery]. Para. 0060, “At this time, if necessary, guide information is superimposed on an optical image of the eye of the patient observed through the eyepiece 32, or guide information is superimposed on the front image displayed on the monitor 33” [a method for guiding ophthalmic surgery]. Further see Para. 0060 and 0079. The examiner has interpreted that performing cataract surgery on a patient using guide information as method for guiding ophthalmic surgery.)
Ootsuki teaches “loading, by a computing device, a plan [hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom, the primary treatment plan and the backup] treatment plan having a common pre-operative image of a patient”. (Para. 0072, “at the time of surgery on a patient, the control unit 66 first acquires, from the interface unit 67, preoperative planning information including information indicating the guide information to be presented as a guide” [loading a treatment plan], “information indicating a presentation position of the guide information, and the like, and preoperative images which are front and tomographic images taken before the surgery” [having a pre-operative image of a patient]. Para. 0075, “The control unit 66 generates guide information from the obtained posture of the eye and the preoperative planning information acquired in advance” [treatment plans generated using planning information, preoperative images, e.g., having a common pre-operative image of a patient]. Para. 0080, “In cataract surgery, as illustrated by an arrow A11 in FIG. 3, a part of a cornea 102 of an eyeball 101 of the patient is first incised with a knife, and a wound 103 is created” [one ophthalmic surgical treatment plan]. “Then, a surgical tool is inserted through the wound 103, and an anterior portion of a crystalline lens 104 located inside the eyeball 101, that is, an anterior capsule portion, is incised in a circular shape”[another treatment plan and e.g. two or more surgical treatment plans being different from one another]. Para. 0181, “The image processing device 302 has an image recognition unit 311, a control unit 312, the interface unit 67, and a guide information generation unit 313. Here, for example, the image recognition unit 311, the control unit 312, and the guide information generation unit 313 are realized when the control unit 66 illustrated in FIG. 2 executes a program” [by a computing device]. Further see Para. 0070, 0075, 0080, and 0181. The examiner has interpreted that acquiring preoperative planning information including preoperative images taken before the surgery and information indicating guide information for performing cataract surgery to include creating a wound and incising the anterior capsule that was generated from the preoperative planning information as loading, by a computing device, a plan, the treatment plan having a common pre-operative image of a patient.)
Ootsuki teaches “receiving, by the computing device, one or more live images of an eye of the patient”. (Para. 0066, “The front image acquisition unit 64 includes, for example, a video camera or the like” [one or more live images]. “The front image acquisition unit 64 receives the observation light that has entered through the observation optical system 62, and photoelectrically converts the observation light, thereby taking an image of the patient's eye observed from the front, that is, a front image obtained by photographing the patient's eye substantially in the eye axis direction. The front image acquisition unit 64 photographs the front image under the control of the control unit 66 and supplies the obtained front image to the control unit 66” [receiving, by the computing device, one or more live images of an eye of the patient]. Further see Para. 0066. The examiner has interpreted that a front image acquisition unit that uses a video camera to photograph an image of the patient’s eye and supply the image to the control unit as receiving, by the computing device, one or more live images of an eye of the patient.)
Ootsuki teaches “initiating, by the computing device, registration of the one or more live images with respect to the pre-operative image”. (Para. 0104, “Further, in the control unit 66, an image of the eye of the patient viewed in the direction identical to the photographing direction of the front image obtained by the front image acquisition unit 64, that is, the eye axis direction, can be obtained by reconstructing the subject using the tomographic images obtained at the respective cross-sectional positions by the tomographic image acquisition unit 65” [e.g., initiating, by the computing device, registration of the one or more live images with respect to the pre-operative image]. Further see Para. 0074, 0104-0105, and 0110-0115. The examiner has interpreted that reconstructing the image of the eye of the patient in the tomographic images to be identical to the front image obtained using a tomographic image acquisition unit as initiating, by the computing device, registration of the one or more live images with respect to the pre-operative image.)
Ootsuki teaches “initiating, by the computing device, on a display device coupled to the computing device, presentation of one or more first steps of the primary treatment plan, the one or more first steps defining superimposition of one or more first guides on the one or more live images”. (Para. 0192, “once the surgery is started, the surgical system 11 performs a guide information presentation process in each of a wound creation mode, an anterior capsule incision mode, and an intraocular lens insertion mode, and presents guide information” [presentation of one or more first steps of the primary treatment plan]. Para. 0060, “At this time, if necessary, guide information is superimposed on an optical image of the eye of the patient observed through the eyepiece 32, or guide information is superimposed on the front image displayed on the monitor 33” [e.g., initiating, by the computing device, on a display device coupled to the computing device, the one or more first steps defining superimposition of one or more first guides on the one or more live images]. Further see Para. 0060 and 0192. The examiner has interpreted that superimposing guide information on the front image displayed on a monitor for a wound creation as initiating, by the computing device, on a display device coupled to the computing device, presentation of one or more first steps of the primary treatment plan of the two or more treatment plans, the one or more first steps defining superimposition of one or more first guides on the one or more live images.)
Ootsuki teaches “receiving, by the computing device, an instruction to switch to the [backup] treatment plan [within the plan hierarchy]”. (Para. 0193, “the wound creation mode is a mode of presenting wound position information as a guide for use by a surgeon in creating a wound, and the anterior capsule incision mode is a mode of presenting anterior capsule incision position information as a guide for use by a surgeon in incising the anterior capsule. In addition, the intraocular lens insertion mode is a mode of presenting intraocular lens direction information as a guide for use by a surgeon in inserting an intraocular lens into the crystalline lens” [e.g., different plans]. Para. 0194, “The surgical system 11 performs the guide information presentation process in each mode while appropriately switching the mode” [e.g., switch treatment plans]. Para. 0194, “the mode may be switched when a surgeon or the like operates the interface unit 67, or may be performed by the surgical system 11 on the basis of a front image or the like” [receiving, by the computing device, an instruction to switch]. Further see Para. 0193-0194. The examiner has interpreted that a surgeon that operates the interface unit to switch the mode between creating a wound and incising the anterior capsule as receiving, by the computing device, an instruction to switch to the treatment plan.)
Ootsuki teaches “in response to the instruction, initiating, by the computing device, on the display device, presentation of one or more second steps of the [backup] treatment plan, the one or more second steps defining superimposition of one or more second guides on the one or more live images, the one or more second guides being different from the one or more first guides.” (Para. 0194, “The surgical system 11 performs the guide information presentation process in each mode while appropriately switching the mode” [e.g., in response to the instruction]. Para. 0192, “once the surgery is started, the surgical system 11 performs a guide information presentation process in each of a wound creation mode, an anterior capsule incision mode, and an intraocular lens insertion mode, and presents guide information” [presentation of one or more second steps of treatment plan different from the primary]. Para. 0060, “At this time, if necessary, guide information is superimposed on an optical image of the eye of the patient observed through the eyepiece 32, or guide information is superimposed on the front image displayed on the monitor 33” [e.g., initiating, by the computing device, on the display device, the one or more second steps defining superimposition of one or more second guides on the one or more live images]. Para. 0192, “once the surgery is started, the surgical system 11 performs a guide information presentation process in each of a wound creation mode, an anterior capsule incision mode, and an intraocular lens insertion mode, and presents guide information” [presentation of one or more first steps of primary treatment plan]. Further see Para. 0060 and 0192-0194. The examiner has interpreted that superimposing guide information on the front image displayed on a monitor for an anterior capsule incision after switch modes in response to the instruction as initiating, by the computing device, on the display device, presentation of one or more second steps of the treatment plan, the one or more second steps defining superimposition of one or more second guides on the one or more live images, the one or more second guides being different from the one or more first guides.)
Ootsuki does not teach “loading, by a computing device, a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom, the primary treatment plan and the backup treatment plan having a common pre-operative image of a patient” and “receiving, by the computing device, an instruction to switch the backup treatment plan within the plan hierarchy; and in response to the instruction, initiating, by the computing device, on the display device, presentation of one or more second steps of the backup treatment plan”.
However, in the same field of endeavor namely creating treatment plans for performing ophthalmic surgery, Fu teaches “loading, by a computing device, a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom, the primary treatment plan and the backup treatment plan having a common pre-operative image of a patient” and “receiving, by the computing device, an instruction to switch the backup treatment plan within the plan hierarchy; and in response to the instruction, initiating, by the computing device, on the display device, presentation of one or more second steps of the backup treatment plan”. (Para. 0009, “During the lenticule incision process, treatment interruptions may occasionally occur, due to various system and process failures such as suction loss in the patient interface device (a device that mechanically couples the patient's eye to the ophthalmic laser system). Such interruptions prevent the completion of the full lenticule formation and may oblige the surgeon to switch to a PRK or LASIK procedure as a re-treatment option. As PRK and LASIK involves a different laser system than corneal lenticule extraction (excimer laser vs. femtosecond laser), this re-treatment option is inconvenient for the patient” [switch to a different treatment option after interruption, e.g., a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom]. Furthermore, Para. 0035, “the partially formed entry cut is disregarded, and the original treatment plan is revised by moving the entry cut position to a new angular position that avoids the partially formed entry cut, and the revised treatment plan is executed to form a new entry cut, a bottom lenticule incision and a top bed incision” [new treatment plan with a new cut e.g., loading a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom]. Para. 0033, “Using the user interface display, the surgeon may move the representation of the incisions to align with the partially formed entry cut in the eye image, and the computer revises the treatment plan accordingly” [receiving an instruction to switch the backup treatment plan within the plan hierarchy and presentation on the display device]. (Para. 0032, “the original treatment plan is revised by aligning its entry cut with the partially formed entry cut (step S205)” [and in response to the instruction, initiating, presentation of the one or more second steps of the backup treatment]. Para. 0041, “Then, a revised treatment plan is generated and executed to form a new top bed incision at a depth that is shallower than the partially formed top bed incision by a predetermined distance (step S216)” [e.g., the primary treatment plan and the backup treatment plan having a common pre-operative image of a patient]. Para. 0033, “The alignment step (step S205) may be performed by the surgeon with the assistance of a user interface display of the ophthalmic laser system. The user interface display displays an image of the patient's eye where the partially formed entry cut is visible, and overlays a representation of the incisions (at least the entry cut) drawn according to the treatment plan” [by the computing device presented on the display device]. Further see Para. 0009, 0027, 0030-0035, and 0041. The examiner has interpreted that revising the original treatment plan by aligning a partially formed entry cut or avoiding the partially formed entry cut to make a new cut at predetermined distances due to a treatment interruption and switching to a different re-treatment option using a user interface display and a surgeon moving the location of the cut as loading, by a computing device, a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom, the primary treatment plan and the backup treatment plan having a common pre-operative image of a patient and receiving, by the computing device, an instruction to switch the backup treatment plan within the plan hierarchy; and in response to the instruction, initiating, by the computing device, on the display device, presentation of one or more second steps of the backup treatment plan.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “loading, by a computing device, a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom, the primary treatment plan and the backup treatment plan having a common pre-operative image of a patient” and “receiving, by the computing device, an instruction to switch the backup treatment plan within the plan hierarchy; and in response to the instruction, initiating, by the computing device, on the display device, presentation of one or more second steps of the backup treatment plan”.” as conceptually seen from the teaching of Fu, into that of Ootsuki because this modification of switching to a new treatment plan for the advantageous purpose of navigating an undesired event that would normally prevent completion of the eye surgery (Fu, Para. 0009 and 0014). Further motivation to combine be that Ootsuki and Fu are analogous art to the current claim are directed to creating treatment plans for performing ophthalmic surgery.
As per claim 2, Ootsuki does not specifically teach “(a) determining, by the computing device, that a portion of the one or more second steps are compatible with a portion of the one or more first steps presented on the display device prior to receiving the instruction to switch to the backup treatment plan, and in response to (a), omitting presentation of the portion of the one or more second steps.”
However, Fu teaches “(a) determining, by the computing device, that a portion of the one or more second steps are compatible with a portion of the one or more first steps presented on the display device prior to receiving the instruction to switch to the backup treatment plan, and in response to (a), omitting presentation of the portion of the one or more second steps.” (Para. 0032, “the original treatment plan is revised by aligning its entry cut with the partially formed entry cut (step S205)” [the one or more second steps of the second treatment plan prior to receiving the instruction to switch to the backup treatment plan], “and the planned lenticule incision procedure is continued with the revised (aligned) treatment plan to form the uncompleted part of the entry cut (i.e. skipping the already formed part of the entry cut)” [the one or more steps need not be repeated, e.g., determining that a portion of the one or more second steps are compatible with a portion of the one or more first steps and in response to (a), omitting presentation of the portion of the one or more second steps]. Para. 0033, “The alignment step (step S205) may be performed by the surgeon with the assistance of a user interface display of the ophthalmic laser system. The user interface display displays an image of the patient's eye where the partially formed entry cut is visible, and overlays a representation of the incisions (at least the entry cut) drawn according to the treatment plan” [by the computing device presented on the display device]. Further see Para 0027 and 0030-0033. The examiner has interpreted that revising the original treatment plan by align an entry cut with a partially formed entry cut and continuing the procedure with a revised treatment plan to skip the already formed part of the entry cut as (a) determining, by the computing device, that a portion of the one or more second steps are compatible with a portion of the one or more first steps presented on the display device prior to receiving the instruction to switch to the backup treatment plan, and in response to (a), omitting presentation of the portion of the one or more second steps.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “(a) determining, by the computing device, that a portion of the one or more second steps are compatible with a portion of the one or more first steps presented on the display device prior to receiving the instruction to switch to the backup treatment plan, and in response to (a), omitting presentation of the portion of the one or more second steps” as conceptually seen from the teaching of Fu, into that of Ootsuki because this modification of identifying steps that are compatible for the advantageous purpose of skipping redundant skips in alternative treatment plans and continuing with the surgery (Fu, Para. 0033). Further motivation to combine be that Ootsuki and Fu are analogous art to the current claim are directed to creating treatment plans for performing ophthalmic surgery.
As per claim 3, Ootsuki does not specifically teach “(b) identifying, by the computing device, an incompatible step of the one or more second steps that is incompatible with the one or more first steps, and in response to (b), initiating, by the computing device, presentation of the one or more second steps with the incompatible step.”
However, Fu teaches “(b) identifying, by the computing device, an incompatible step of the one or more second steps that is incompatible with the one or more first steps, and in response to (b), initiating, by the computing device, presentation of the one or more second steps with the incompatible step.” (Para. 0032, “the original treatment plan is revised by aligning its entry cut with the partially formed entry cut (step S205)” [the one or more second steps of the second treatment plan prior to receiving the instruction to switch to the second plan], “and the planned lenticule incision procedure is continued with the revised (aligned) treatment plan to form the uncompleted part of the entry cut (i.e. skipping the already formed part of the entry cut)” [the one or more steps need not be repeated, e.g., identifying an incompatible step of the one or more second steps that is incompatible with the one or more first steps and in response to (b), initiating presentation of the one or more second steps with the incompatible step]. Para. 0033, “The alignment step (step S205) may be performed by the surgeon with the assistance of a user interface display of the ophthalmic laser system. The user interface display displays an image of the patient's eye where the partially formed entry cut is visible, and overlays a representation of the incisions (at least the entry cut) drawn according to the treatment plan” [by the computing device presented on the display device]. Further see Para 0027 and 0030-0033. The examiner has interpreted that revising the original treatment plan by align an entry cut with a partially formed entry cut and continuing the procedure with a revised treatment plan to skip the already formed part of the entry cut as (b) identifying, by the computing device, an incompatible step of the one or more second steps that is incompatible with the one or more first steps, and in response to (b), initiating, by the computing device, presentation of the one or more second steps with the incompatible step.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “(b) identifying, by the computing device, an incompatible step of the one or more second steps that is incompatible with the one or more first steps, and in response to (b), initiating, by the computing device, presentation of the one or more second steps with the incompatible step” as conceptually seen from the teaching of Fu, into that of Ootsuki because this modification of identifying steps that are incompatible for the advantageous purpose of only completing steps that are not redundant in alternative treatment plans and continuing with the surgery (Fu, Para. 0033). Further motivation to combine be that Ootsuki and Fu are analogous art to the current claim are directed to creating treatment plans for performing ophthalmic surgery.
As per claim 6, Ootsuki teaches “wherein [the one or more first steps] include an incision step, a removal step corresponding to removal of a crystalline lens of the eye of the patient, a centration step of an intraocular lens (IOL), and an alignment step of an IOL axis of the IOL.” (Para. 0080, “In cataract surgery, as illustrated by an arrow A11 in FIG. 3, a part of a cornea 102 of an eyeball 101 of the patient is first incised with a knife, and a wound 103 is created” [an incision step]. Para. 0081, “Then, as illustrated by an arrow A12, a surgical tool is inserted through the wound 103 into the anterior capsule incised portion of the crystalline lens 104. Emulsification (pulverization) and suction of the nucleus of the crystalline lens 104 are performed by means of ultrasonic vibration” [a removal step corresponding to removal of a crystalline lens of the eye of the patient], “which is called a nucleus treatment, and the cortex is also sucked. Thereafter, an intraocular lens 105 is inserted into the crystalline lens 104 as illustrated by an arrow A13” [a centration step of an intraocular lens (IOL)]. Para. 0085, “Further, as illustrated in FIG. 6, the direction of the intraocular lens with respect to the eye 131 of the patient on the front image for disposing the intraocular lens is designated as an intraocular lens orientation 151. In this example, the intraocular lens orientation 151 is represented by a straight line” [an IOL axis of the IOL]. Para. 0092, “the corneal limbus information G11 and intraocular lens direction information G14 indicating the orientation of the intraocular lens are superimposed on the optical image of the eye of the patient and presented on the presentation unit 63 as the guide information. The surgeon inserts the intraocular lens into the crystalline lens of the patient's eye such that the intraocular lens is oriented in the direction indicated by the intraocular lens direction information G14” [and an alignment step of an IOL axis of the IOL]. Further see Para. 0080-0085 and 0092-0093. The examiner has interpreted that incising a part of a cornea, pulverization and suction of the crystalline lens, inserting the intraocular lens, and orienting the intraocular lens orientation on the front image to indicate the direction of the intraocular lens.)
Ootsuki does not specifically teach multiple steps are included in “the one or more first steps” such as “wherein the one or more first steps comprise a plurality of first steps”.
However, Fu teaches “the one or more first steps” and “wherein the one or more first steps comprise a plurality of first steps”. (Para. 0028, “In a corneal lenticule extraction procedure according to a first embodiment of the present invention, the lenticule incision process includes the following three segments in the order they are executed (see FIG. 1, side view): an entry cut 101, a bottom lenticule incision 102, and a flat top bed incision 103.” [the one or more first steps comprise a plurality of first steps]. Further see Para. 0028 and 0030. The examiner has interpreted having a the lenticule incision process that includes an entry cut 101, a bottom lenticule incision 102, and a flat top bed incision 103 as wherein the one or more first steps comprise a plurality of first steps.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add multiple steps are included in “the one or more first steps” and “wherein the one or more first steps comprise a plurality of first steps” as conceptually seen from the teaching of Fu, into that of Ootsuki because this modification of having the first treatment plan have multiple steps for the advantageous purpose of identifying different sets of steps to be completed in alternative treatment plans for continuing with the surgery (Fu, Para. 0030 and 0033). Further motivation to combine be that Ootsuki and Fu are analogous art to the current claim are directed to creating treatment plans for performing ophthalmic surgery.
Re Claim 7, it is a method claim, having similar limitations of claim 6. Thus, claim 7 is also rejected under the similar rationale as cited in the rejection of claim 6.
Furthermore, regarding claim 7, Ootsuki teaches “receiving the instruction to switch to the [backup] treatment plan [prior to completing presentation of all steps of the plurality of first steps].” (Para. 0193, “the wound creation mode is a mode of presenting wound position information as a guide for use by a surgeon in creating a wound, and the anterior capsule incision mode is a mode of presenting anterior capsule incision position information as a guide for use by a surgeon in incising the anterior capsule. In addition, the intraocular lens insertion mode is a mode of presenting intraocular lens direction information as a guide for use by a surgeon in inserting an intraocular lens into the crystalline lens” [e.g., different plans]. Para. 0194, “The surgical system 11 performs the guide information presentation process in each mode while appropriately switching the mode” [e.g., switch to a second plan]. Para. 0194, “the mode may be switched when a surgeon or the like operates the interface unit 67, or may be performed by the surgical system 11 on the basis of a front image or the like” [receiving an instruction to switch]. Further see Para. 0193-0194. The examiner has interpreted that a surgeon that operates the interface unit to switch the mode between creating a wound and incising the anterior capsule as receiving the instruction to switch to the treatment plan.)
Ootsuki does not specifically teach “receiving the instruction to switch to the backup treatment plan prior to completing presentation of all steps of the plurality of first steps.”
However, Fu teaches “receiving the instruction to switch to the backup treatment plan prior to completing presentation of all steps of the plurality of first steps.” (Para. 0032, the original treatment plan is revised by aligning its entry cut with the partially formed entry cut (step S205), and the planned lenticule incision procedure is continued with the revised (aligned) treatment plan to form the uncompleted part of the entry cut (i.e. skipping the already formed part of the entry cut), the top bed incision and the bottom lenticule incision (step S206)” [receiving the instruction to switch to the backup treatment plan prior to completing presentation of all steps of the plurality of first steps]. Further see Para. 0032, 0037, 0042, and 0051. The examiner has interpreted that revising the original treatment plan by aligning its entry cut with the partially formed entry cut and forming the uncompleted part of the entry cut as receiving the instruction to switch to the backup treatment plan of the two or more treatment plans prior to completing presentation of all steps of the plurality of first steps.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add multiple steps are included in “receiving the instruction to switch to the backup treatment plan prior to completing presentation of all steps of the plurality of first steps” as conceptually seen from the teaching of Fu, into that of Ootsuki because this modification of implementing a second treatment plan before the first treatment plan is finished for the advantageous purpose of continuing with the surgery with an alternative treatment plans by navigating an undesired event that would normally prevent completion of the eye surgery (Fu, Para. 0009, 0014, and 0031-0032). Further motivation to combine be that Ootsuki and Fu are analogous art to the current claim are directed to creating treatment plans for performing ophthalmic surgery.
As per claim 9, Ootsuki teaches “wherein the one or more first guides include one or more of: an incision indicator; a rhexis guide; a limbal release incision guide (LRI); a centration guide; or an intraocular lens (IOL) axis.” (Para. 0085, “Further, as illustrated in FIG. 6, the direction of the intraocular lens with respect to the eye 131 of the patient on the front image for disposing the intraocular lens is designated as an intraocular lens orientation 151. In this example, the intraocular lens orientation 151 is represented by a straight line” [wherein the one or more first guides include an intraocular lens (IOL) axis]. Further see Para. 0092, “the corneal limbus information G11 and intraocular lens direction information G14 indicating the orientation of the intraocular lens are superimposed on the optical image of the eye of the patient and presented on the presentation unit 63 as the guide information. The surgeon inserts the intraocular lens into the crystalline lens of the patient's eye such that the intraocular lens is oriented in the direction indicated by the intraocular lens direction information G14” [wherein the one or more first guides include an intraocular lens (IOL) axis]. Further see Para. 0085 and 0092 and Fig. 6. The examiner has interpreted that orienting the intraocular lens orientation on the front image to indicate the direction of the intraocular lens as wherein the one or more first guides include an intraocular lens (IOL) axis.)
As per claim 10, Ootsuki teaches “initiating presentation of the one or more second steps without again initiating registration of the one or more live images with respect to the pre-operative image.” (Para. 0214-0215, “The guide information presentation process in the case of the wound creation mode has been described in detail so far. Note that in the case of the anterior capsule incision mode and in the case of the intraocular lens insertion mode, processes similar to the guide information presentation process described with reference to FIG. 17 are performed. For example, in the case of the anterior capsule incision mode, in step S14, as in the case of the wound creation mode, the control unit 312 supplies the information indicating the corneal range to the guide information generation unit 313, and instructs the guide information generation unit 313 to generate the corneal limbus information as the guide information” [after switch modes, immediate go the guide generation step, e.g., initiating presentation of the one or more second steps without again initiating registration of the one or more live images with respect to the pre-operative image]. Further see Para. 0214-0215. The examiner has interpreted that generating the guide information for the anterior capsule incision mode after the wound creation mode is ended as initiating presentation of the one or more second steps without again initiating registration of the one or more live images with respect to the pre-operative image.)
Re Claim 11, it is a system claim, having similar limitations of claim 1. Thus, claim 11 is also rejected under the similar rationale as cited in the rejection of claim 1.
Furthermore, regarding claim 11, Ootsuki teaches “A system for guiding ophthalmic surgery comprising: one or more processing devices; and one or more memory devices coupled to the one or more processing devices and storing executable code that, when executed by the one or more processing devices, causes the one or more processing devices” and “receive a live video of an eye of the patient”. (Para. 0271, “FIG. 23 is a block diagram illustrating an exemplary configuration of the hardware of the computer that executes the above-mentioned sequence of processes by means of the program” [e.g., A system for guiding ophthalmic surgery]. Para. 0272, “In the computer, a central processing unit (CPU) 501, a read only memory (ROM) 502, and a random access memory (RAM) 503 are coupled to one another by a bus 504” [comprising: one or more processing devices one or more memory devices coupled to the one or more processing devices]. Para. 0275, “In the computer configured as mentioned above, the CPU 501 loads, for example, the program recorded in the recording unit 508 on the RAM 503 via the input/output interface 505 and the bus 504, and executes the program, whereby the above-mentioned sequence of processes is performed” [memory storing executable code that, when executed by the one or more processing devices, causes the one or more processing devices]. Para. 0066, “The front image acquisition unit 64 includes, for example, a video camera or the like” [live video]. “The front image acquisition unit 64 receives the observation light that has entered through the observation optical system 62, and photoelectrically converts the observation light, thereby taking an image of the patient's eye observed from the front, that is, a front image obtained by photographing the patient's eye substantially in the eye axis direction. The front image acquisition unit 64 photographs the front image under the control of the control unit 66 and supplies the obtained front image to the control unit 66” [receive a live video of an eye of the patient]. Further see Para. 0271-0275 and 0066. The examiner has interpreted that a computer that executes a program recorded on the random access memory coupled with a central processing unit that executes the program as described in this invention in addition to a front image acquisition unit that uses a video camera to photograph an image of the patient’s eye and supply the image to the control unit as a system for guiding ophthalmic surgery comprising: one or more processing devices; and one or more memory devices coupled to the one or more processing devices and storing executable code that, when executed by the one or more processing devices, causes the one or more processing devices and receive a live video of an eye of the patient.)
Re Claim 12, it is a system claim, having similar limitations of claim 2. Thus, claim 12 is also rejected under the similar rationale as cited in the rejection of claim 2.
Re Claim 13, it is a system claim, having similar limitations of claim 3. Thus, claim 13 is also rejected under the similar rationale as cited in the rejection of claim 3.
Re Claim 16, it is a system claim, having similar limitations of claim 6. Thus, claim 16 is also rejected under the similar rationale as cited in the rejection of claim 6.
Re Claim 17, it is a system claim, having similar limitations of claim 7. Thus, claim 17 is also rejected under the similar rationale as cited in the rejection of claim 7.
Re Claim 19, it is a system claim, having similar limitations of claim 9. Thus, claim 19 is also rejected under the similar rationale as cited in the rejection of claim 9.
Re Claim 20, it is a system claim, having similar limitations of claim 10. Thus, claim 20 is also rejected under the similar rationale as cited in the rejection of claim 10.
Claims 4-5 and 14-15 are rejected under 35 U.S.C. § 103 as being unpatentable over Ootsuki and Fu as applied to claim 1 above, and further in view of Aaron, Maria M., Sherleen Chen, James A. Davison, A. Tim Johnson, and Kevin M. Miller. “Complex Case Management: Choice of IOL After an Anterior Capsular Tear.” CATARACT & REFRACTIVE SURGERY TODAY, pp. 43-46. June 2011 [herein “Aaron”].
As per claim 4, Ootsuki and Fu do not specifically teach “wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) and the backup treatment plan corresponds to placement of a non-toric IOL.”
However, in the same field of endeavor namely creating treatment plans for performing ophthalmic surgery, Aaron teaches “wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) and the backup treatment plan corresponds to placement of a non-toric IOL.” (Pg. 43, “You are finishing cataract surgery. After removing all of the cortical material, you discover a tear in the anterior capsule, most likely from its being struck by the phaco needle (Figure 1). The posterior capsule is intact. You had planned to implant a single-piece acrylic toric IOL” [wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL)]. Pg. 43, “If exploration revealed an ART, I would abandon the toric lens” [the backup treatment plan corresponds to placement of a non-toric IOL]. Further see Pg. 43. The examiner has interpreted that when in the process of finishing a cataract surgery to implant a single-piece acrylic toric IOL and abandoning the toric lens for a three-piece IOL designed as wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) and the backup treatment plan corresponds to placement of a non-toric IOL.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) and the backup treatment plan corresponds to placement of a non-toric IOL” as conceptually seen from the teaching of Aaron, into that of Ootsuki and Fu because this modification of using a non-toric IOL instead of a toric IOL for the advantageous purpose of increasing the stability of the IOL when a tear occurs in the capsular (Aaron, Pg. 43). Further motivation to combine be that Ootsuki, Fu, and Aaron are analogous art to the current claim are directed to creating treatment plans for performing ophthalmic surgery.
As per claim 5, Ootsuki and Fu do not specifically teach “wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) in a capsular bag of the eye of the patient and the backup treatment plan corresponds to sulcus placement of a non-toric IOL.”
However, Aaron teaches “wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) in a capsular bag of the eye of the patient and the backup treatment plan corresponds to sulcus placement of a non-toric IOL.” (Pg. 43, “You are finishing cataract surgery. After removing all of the cortical material, you discover a tear in the anterior capsule, most likely from its being struck by the phaco needle (Figure 1). The posterior capsule is intact. You had planned to implant a single-piece acrylic toric IOL” [wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL)]. Pg. 43, “I would explore under the iris with a Kuglen hook to determine the extent of the capsular defect. If a complete bite from the phaco tip were visible, then the capsular situation would be stable” [in a capsular bag of the eye of the patient]. Pg. 43, “If exploration revealed an ART, I would abandon the toric lens” [the backup treatment plan corresponds to placement of a non-toric IOL]. Pg. 43, “Placing a three-piece IOL designed for the sulcus is the option least likely to cause a posterior extension of the tear” [sulcus placement of a non-toric IOL]. Further see Pg. 43. The examiner has interpreted that when in the process of finishing a cataract surgery to implant a single-piece acrylic toric IOL in the capsular bag and abandoning the toric lens for a three-piece IOL designed for the sulcus as wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) in a capsular bag of the eye of the patient and the backup treatment plan corresponds to sulcus placement of a non-toric IOL.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the primary treatment plan corresponds to placement of a toric intraocular lens (IOL) in a capsular bag of the eye of the patient and the backup treatment plan corresponds to sulcus placement of a non-toric IOL” as conceptually seen from the teaching of Aaron, into that of Ootsuki and Fu because this modification of using a non-toric IOL in the sulcus instead of a toric IOL in the capsular bag for the advantageous purpose of increasing the stability of the IOL when a tear occurs in the capsular (Aaron, Pg. 43). Further motivation to combine be that Ootsuki, Fu, and Aaron are analogous art to the current claim are directed to creating treatment plans for performing ophthalmic surgery.
Re Claim 14, it is a system claim, having similar limitations of claim 4. Thus, claim 14 is also rejected under the similar rationale as cited in the rejection of claim 4.
Re Claim 15, it is a system claim, having similar limitations of claim 5. Thus, claim 15 is also rejected under the similar rationale as cited in the rejection of claim 5.
Claims 8 and 18 are rejected under 35 U.S.C. § 103 as being unpatentable over Ootsuki and Fu as applied to claim 7 above, and further in view of Aaron, and in further view of US 2019/0357980 A1 Andrews, Delbert Peter [herein “Andrews”].
As per claim 8, neither Ootsuki or Fu specifically teach “performing, by the computing device, a second post-operative data collection step included in the one or more second steps and omitting performance of a first post-operative data collection step included in the one or more first steps.”
However, Aaron teaches “performing [by the computing device] a second post-operative [data collection] step included in the one or more second steps and omitting performance of a first post-operative data collection step included in the one or more first steps.” (Pg. 44, “Residual astigmatism could be addressed with limbal relaxing incisions or laser vision correction postoperatively” [performing a second post-operative step included in the one or more second steps]. Pg. 43, “If exploration revealed an ART, I would abandon the toric lens” [abandon the first treatment plan, e.g., omitting performance of a first post-operative data collection step included in the one or more first steps]. Pg. 43, “Placing a three-piece IOL designed for the sulcus is the option least likely to cause a posterior extension of the tear” [performing the one or more second steps]. Further see Pg. 43. The examiner has interpreted that abandoning the toric lens for a three-piece IOL designed for the sulcus and addressing residual astigmatism as performing a second post-operative step included in the one or more second steps and omitting performance of a first post-operative data collection step included in the one or more first steps.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “performing [by the computing device] a second post-operative [data collection] step included in the one or more second steps and omitting performance of a first post-operative data collection step included in the one or more first steps” as conceptually seen from the teaching of Aaron, into that of Ootsuki and Fu because this modification of using a non-toric IOL in the sulcus instead of a toric IOL and addressing results postoperatively for the advantageous purpose of ensuring that the patient’s astigmatism is still corrected in the event of a change in the surgery (Aaron, Pg. 43-44). Further motivation to combine be that Ootsuki, Fu, and Aaron are analogous art to the current claim are directed to creating treatment plans for performing ophthalmic surgery.
Ootsuki, Fu, and Aaron do not teach “by the computing device” and that the second post-operative step is a “data collection step”.
However, in the same field of endeavor namely creating treatment plans for performing ophthalmic surgery, Andrews teaches “by the computing device” and “data collection step”. (Para. 0075, “the planning device comprises a special interface to gather post-operation results of the patients (refraction and residual astigmatism) to verify and improve the quality and to evaluate specific adjustment factors” [post-operative data collection step by the computing device]. Further see Para. 0075. The examiner has interpreted that having a special interface on a planning device that gathers post-operation results of patients as data collection step by the computing device.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “by the computing device” and “data collection step” as conceptually seen from the teaching of Andrews, into that of Ootsuki, Fu, and Aaron because this modification of having a post-operation step collect data using a computing device for the advantageous purpose of ensuring that the patient’s astigmatism is improved after the surgery (Andrews, Para. 0008). Further motivation to combine be that Ootsuki, Fu, Aaron, and Andres are analogous art to the current claim are directed to creating treatment plans for performing ophthalmic surgery.
Re Claim 18, it is a system claim, having similar limitations of claim 8. Thus, claim 18 is also rejected under the similar rationale as cited in the rejection of claim 8.
Response to Arguments
Applicant’s arguments, see Pg. 12-13, filed January 26, 2026, with respect to the rejection(s) of claims 1 and 11 under 35 U.S.C. 102(a)(1) 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 the amended claims in the rejection and previously cited art, as necessitated by the amendment, above.
Applicant's arguments filed on January 26, 2026 have been fully considered but they are not persuasive.
Applicant argues that claim features are patent eligible under 35 U.S.C. § 101 because the claims do not recite mental processes as they require the use of a computer. (See Applicant’s response, Pg. 10-11).
MPEP § 2106.04(a)(2)(III)(A) recites “claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions”, “claims can recite a mental process even if they are claimed as being performed on a computer”, and “in evaluating whether a claim that requires a computer recites a mental process, examiners should carefully consider the broadest reasonable interpretation of the claim in light of the specification. For instance, examiners should review the specification to determine if the claimed invention is described as a concept that is performed in the human mind and applicant is merely claiming that concept performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept. In these situations, the claim is considered to recite a mental process.” Also, MPEP § 2106.04(a)(2)(III)(D) recites “Examples of product claims reciting mental processes include: A wide-area real-time performance monitoring system for monitoring and assessing dynamic stability of an electric power grid – Electric Power Group, 830 F.3d at 1351 and n.1, 119 USPQ2d at 1740 and n.1”.
The examiner has provided the rational for the claim limitations that are being directed to a mental process in the rejection above. For example, the limitation of amended claim 1“initiating registration of the one or more live images with respect to the pre-operative image” can be conducted as a person mentally determining or drawing with pen and paper how a frame of a captured video feed of a patient’s eye correlates to given pre-operative image of the patent by determining the orientation of the frame and rotating the frame to match the orientation of the pre-operative image. This can be done consecutively for all frames of a live image by a person mentally through a series of repetitive rotating of the image for each frame. The applicant is merely claiming the abstract idea be performed on a computer. Additionally, the limitation of “presentation of one or more second steps of the backup treatment plan, the one or more second steps defining superimposition of one or more second guides on the one or more live images, the one or more second guides being different from the one or more first guides” can be conducted as a person mentally modifying or drawing with pen and paper frame of a captured video feed of a patient’s eye by with a different treatment plan, indicating the location of an intraocular lens (IOL) axis with respect the eye orientation for a backup surgery on the frame. Again, this can be done consecutively for all frames of a live image by a person mentally through a series of repetitive rotating of the image for each frame given the backup treatment plan. The applicant is merely claiming the abstract idea be performed on a computer.
The examiner has properly identified that the claims recite a mental concept as provided in the rejection above is proper under the framework provided in the 2019 Patent Eligibility Guidance and MPEP § 2106.04(a)(2)(III)(C). The claims are directed to judicial exception, an abstract idea.
Applicant argues that claim features are patent eligible under 35 U.S.C. § 101 because the claim is integrated into a practical application as claim features recite improvements to another technology or technical field (See Applicant’s response, Pg. 9-11).
MPEP § 2106.05(a) recites “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” MPEP § 2106.04(d)(II) recites “examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application”. MPEP § 2106.05(a) also recites “Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality: Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a loan-application process by enabling borrowers to avoid physically going to or calling each lender and filling out a loan application, LendingTree, LLC v. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed. Cir. 2016) (non-precedential)”. MPEP § 2106.05(d)(II) recites “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”.
The examiner has provided the rational for the independent claim limitations that are being directed to a mental process in the rejection above. The additional element of “loading, by a computing device, a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom, having a common pre-operative image of a patient”, while not an abstract idea, is merely using the generic computer components and functions being used as a tool to perform the abstract idea as well as merely insignificant extra-solution data storing and retrieving activity, which are Well-Understood, Routine and Conventional. Furthermore, the additional elements of “by the computing device”, “by the computing device, on a display device coupled to the computing device”, and “by the computing device, on the display device”, and “A system for guiding ophthalmic surgery comprising: one or more processing devices; and one or more memory devices coupled to the one or more processing devices and storing executable code that, when executed by the one or more processing devices” which is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) with the broadest reasonable interpretation, which does not integrate a judicial exception into elements. Additionally, the additional elements of “receiving one or more live images of an eye of the patient”, “receiving an instruction to switch to a second plan of the two or more treatment plans”, and “receive a live video of an eye of the patient” which is merely a recitation of insignificant data gathering activities (see MPEP § 2106.05(g)) which does not integrate a judicial exception into practical application. The claim as a whole, as pointed out by the applicant, is directed to automating the viewing of multiple surgical plans, but mere automation of a manual process is not sufficient to show an improvement in computer-functionality. Finally, the device itself is not improved upon since the device only reacts to instruction, i.e., from a surgeon under BRI, to move to the next treatment plan, and the device itself, as claimed, only presents the backup plan after given the instruction to do so. Therefore, there are no additional element limitations in the independent claims or the claims as a whole which can integrate the abstract idea into a practical application by improvements to the technology as listed in MPEP § 2106.04(d)(I). Furthermore, the examiner has also provided the rational for the dependent claim limitations that are being directed to a mental process in the rejection above. With the exception of the additional element limitations in the dependent claims which are merely using the generic computer components and functions being used as a tool to perform the abstract idea and insignificant extra-solution activities, there are no additional limitations in the dependent claims which can integrate the abstract idea into a practical application by improvements to the technology or through the use of meaningful limitations.
Therefore, the examiner has properly identified that the claims recite mental processes and limitations that merely use the computer as a tool to perform the abstract idea or insignificant extra-solution activities.
Applicant argues that the combination of references does not teach each and every limitation in the amend claims 13 because cited references fail to teach “a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom” (See Applicant’s response, Pg. 13).
MPEP § 2143.03 cites “All words in a claim must be considered in judging the patentability of that claim against the prior art” and “Examiners must consider all claim limitations when determining patentability of an invention over the prior art.”
While Ootsuki doesn’t disclose “a plan hierarchy comprising a primary treatment plan and a backup treatment plan branching therefrom”, “switch the backup treatment plan within the plan hierarchy”, and “presentation of one or more second steps of the backup treatment plan”, Fu discloses this as revising the original treatment plan by aligning a partially formed entry cut or avoiding the partially formed entry cut to make a new cut at predetermined distances due to a treatment interruption and switching to a different re-treatment option using a user interface display and a surgeon moving the location of the cut. A new cut being made as a result of the incompletion of the first surgery, is a backup plan to the primary treatment plan. Thus, the revision of the original plan to include placement of the new cut with respect to the old cut teaches these limitations.
Therefore, all of the limitations of the amended claims 1 and 11 are disclosed in Ootsuki or Fu, and the combination of these references renders the claimed invention obvious. Therefore, applicant’s arguments are not persuasive and the rejection of claim 1 and 11 as over Ootsuki in view of Fu is given.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Astbury, Nick, Mark Wood, Uday Gajiwala, Rajesh Patel, Yi Chen, Larry Benjamin, and Sunday O. Abuh. "Management of capsular rupture and vitreous loss in cataract surgery." Community eye health 21, no. 65 (2008): 6. et al. teaches of solutions to overcome complications arise during eye surgery and continue on the additional plans.
Hayashi, Ken, Akira Hirata, and Hideyuki Hayashi. "Possible predisposing factors for in-the-bag and out-of-the-bag intraocular lens dislocation and outcomes of intraocular lens exchange surgery." Ophthalmology 114, no. 5 (2007): 969-975 using alternative treatment plans when complications arise during eye surgery.
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.
Examiner’s Note: The examiner has cited particular columns and line numbers in the reference that applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. In the case of amending the claimed invention, the applicant is respectfully requested to indicate the portion(s) of the specification which dictate(s) the structure relied on for the proper interpretation and also to verify and ascertain the metes and bound of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Simeon P Drapeau whose telephone number is (571)-272-1173. The examiner can normally be reached Monday - Friday, 8 a.m. - 5 p.m. ET.
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/SIMEON P DRAPEAU/ Examiner, Art Unit 2188
/RYAN F PITARO/ Supervisory Patent Examiner, Art Unit 2188
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