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 .
Claim Objections
Claim 6 is objected to because of the following informalities: The phrase “the processor is further configured to execute the instructions to at least one of record” is confusing. Typically, instructions would be “communicated” or “transmitted” to a record, not “executed”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1
The claimed invention in claims 1-15 are directed to statutory subject matter as the claims recite an ophthalmic surgical feedback system and method.
Step 2A, Prong One
Regarding claims 1 15, the recited steps are directed to a mental process and mathematical calculation of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (I) and (III)).
Regarding claims 1, 9, and 15, the limitations of “determine strength of the eye tissue at the at least one location based on the biomechanics information; and generate feedback related to utilization of a surgical instrument at the at least one location based on the determined strength” are nothing more than a mental process or mathematical calculation as drafted. For example, these steps are nothing more than a medical professional analyzing sensed data from optical sensor such as an OCT sensor and making recommendations related to a surgical instrument in relation to the ophthalmic structure.
Step 2A, Prong Two
For claims 1 and 15, the judicial exception is not integrated into a practical application. In particular, the step of “emit light to at least one location on eye tissue of a patient and generate biomechanics information for the at least one location based on the light” amounts to no more than pre-solution activity of data gathering. The “laser” appears to be a generic laser recited at a high-level of generality. Additionally, the claims recite “a memory” and “a processor”. The memory and processor are recited a high-level of generality and amounts to nothing more than generic computing structure.
Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The laser, memory, and processor disclosed by the applicant are well-understood, routine, and conventional. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 2-14 further limit the abstract idea already indicated in independent claims 1 and 15 and they are ineligible for the same reasons provided for claims 1 and 15 above. For these reasons, there is no inventive concept in the claims and thus they are ineligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-7, 10-11, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hipsley (Pub. No.: US 2018/0000339 A1).
Regarding claims 1 and 15, Hipsley discloses an ophthalmic surgical feedback system (e.g. see figure 25C, element 2550, [0444], [0254]), comprising: a laser device (e.g. see [0041], [0252] [0491], Note: OCT and Brillouin Scattering both use lasers) configured to emit light to at least one location on eye tissue of a patient and generate biomechanics information (e.g. see [0445]) for the at least one location based on the light; a memory (e.g. see [0441]) comprising executable instructions; and a processor (e.g. see [0441]) in communication with the laser device and the memory and configured to execute the instructions to: determine strength of the eye tissue at the at least one location based on the biomechanics information (e.g. see [0445], [0285], [0290]. Note: In [0445], almost all of the 16 functions will read on “strength of the eye tissue”. Also, [0285], [0290] disclose taking the biomechanics from the FEM and converting it into tissue structure including muscle fibers); and generate feedback related to utilization of a surgical instrument at the at least one location based on the determined strength (e.g. see figure 25C, element 2550, [0444]-[0445]).
Regarding claim 2, Hipsley discloses the eye tissue comprises retinal tissue (e.g. see [0258], [0445]).
Regarding claim 3, Hipsley discloses the eye tissue comprises corneal tissue (e.g. see [0258], [0445]).
Regarding claim 4, Hipsley discloses the generation of the feedback comprises establishment of a value of a surgical parameter related to the utilization of the surgical instrument at the at least one location (e.g. see figure 25C, element 2550, [0444]-[0445], [0478]-[0480]. Note: The examiner is interpreting pore depth and ablation rate in the prior art as the value of the surgical parameter in the claims).
Regarding claim 6, Hipsley discloses the processor is further configured to execute the instructions to at least one of record (e.g. see [0441]) or display data related to the generated feedback (e.g. see [0251], [0444]).
Regarding claim 7, Hipsley discloses the at least one location comprises a plurality of locations on the eye tissue of the patient (e.g. see [0258], [0445]).
Regarding claim 10, Hipsley discloses the determination of strength comprises a quantification based on a predetermined scale (e.g. see [0036], [0285], [0290]. The material properties in [0285] assigned to the different structures along with the finite element model will read on a predetermined scale).
Regarding claim 11, Hipsley discloses wherein the generation of the biomechanics information is based on Brillouin spectroscopy (e.g. see [0491]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5, 8, 9, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hipsley in view of Leiderman et al. (Pub. No.: US 2022/0104884 A1); hereinafter referred to as “Leiderman”.
Regarding claim 5, Hipsley discloses the surgical parameter (e.g. see [0478]-[0480]. Note: The examiner is interpreting pore depth and ablation rate in the prior art as surgical parameters) but is silent as to the surgical parameter comprises at least one of force per unit area or power output. Leiderman teaches it is known to use such a modification as set forth in [0010] and [0015] for the force per unit area and [0012] and [0015] for the power output to provide feedback in real-time that is configured to guide users of the system to avoid contacting and/or perturbing defined anatomical structures during a surgical procedure, or to inform tremor dampening, or changing ratio of applied force-to-movement of the surgical instrument mediated by the haptic feedback device in some cases based on feedback force associated with the surgical instrument (e.g. see [0015]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the surgical parameter comprises at least one of force per unit area or power output as taught by Leiderman in the system/method of Hipsley, since said modification would provide the predictable results of providing feedback in real-time that is configured to guide users of the system to avoid contacting and/or perturbing defined anatomical structures during a surgical procedure, or to inform tremor dampening, or changing ratio of applied force-to-movement of the surgical instrument mediated by the haptic feedback device in some cases based on feedback force associated with the surgical instrument.
Regarding claims 8 and 9, Hipsley discloses intraoperative feedback (e.g. see [0444]-[0445], figure 25C, element 2550) but is silent as the generation of the feedback comprises selecting one or more locations of the plurality of locations for utilization of the surgical instrument and to the processor is further configured to: intraoperatively detect a location of interest related to utilization of the surgical instrument; determine intraoperative feedback for the location of interest; and output the intraoperative feedback. Leiderman teaches it is known to use such a modification as set forth in [0016] to provide feedback in real-time that is configured to guide users of the system to avoid contacting and/or perturbing defined anatomical structures during a surgical procedure (e.g. see [0015]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the surgical parameter comprises at least one of force per unit area or power output as taught by Leiderman in the system/method of Hipsley, since said modification would provide the predictable results of providing feedback in real-time that is configured to guide users of the system to avoid contacting and/or perturbing defined anatomical structures during a surgical procedure.
Regarding claim 12, Hipsley discloses the surgical parameter intraoperative feedback (e.g. see [0444]-[0445], figure 25C, element 2550) but is silent as to the processor is further configured to provide at least a portion of the feedback as a command to a robotic surgical system, wherein the at least a portion of the feedback comprises at least one of a command or a configuration related to utilization of the surgical instrument. Leiderman teaches it is known to use such a modification as set forth in [0010]-[0016] to provide feedback in real-time that is configured to guide users of the system to avoid contacting and/or perturbing defined anatomical structures during a surgical procedure, or to inform tremor dampening, or changing ratio of applied force-to-movement of the surgical instrument mediated by the haptic feedback device in some cases based on feedback force associated with the surgical instrument (e.g. see [0015]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use said modification as taught by Leiderman in the system/method of Hipsley, since said modification would provide the predictable results of providing feedback in real-time that is configured to guide users of the system to avoid contacting and/or perturbing defined anatomical structures during a surgical procedure, or to inform tremor dampening, or changing ratio of applied force-to-movement of the surgical instrument mediated by the haptic feedback device in some cases based on feedback force associated with the surgical instrument.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hipsley in view of Hallen (Pub. No.: US 2019/0099226 A1); hereinafter referred to as “Hallen”.
Regarding claim 13, Hipsely discloses using the feedback for a surgical instrument (e.g. see figure 25C, element 2550, [0444]-[0445]) but is silent as to the surgical instrument comprises an ophthalmic handpiece. Hallen teaches it is known to use such a modification as set forth in [0048] to provide a surgical console(s) that can also be coupled with a variety of other devices and applications such as diagnostic devices, surgical training applications, surgical practice administration applications, etc. (e.g. see [0048]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use an ophthalmic handpiece as taught by Hallen in the system/method of Hipsley, since said modification would provide the predictable results of a surgical console(s) that can also be coupled with a variety of other devices and applications such as diagnostic devices, surgical training applications, surgical practice administration applications, etc.
Regarding claim 14, Hipsley discloses a display (e.g. see [0251], [0444]) but is silent as to the processor is further configured to execute the instructions to cause the display to: display an image of an eye; and overlay the image with at least a portion of the feedback. Hallen teaches it is known to use such a modification as set forth in figure 4A, elements 408-416, [0056] (“Also, a variety of graphical overlays 408, 410, 412, 414, 416 can be displayed along with the image of the eye”) to display a real-time surgical data overlay with real-time surgical data (e.g. see [0056]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use graphical overlays as taught by Hallen in the system/method of Hipsley, since said modification would provide the predictable results of displaying a real-time surgical data overlay with real-time surgical data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Hipsley (Pub. No.: US 2019/0105200 A1) and Hipsley et al. (Pub. No. 2022/0125639 A1) (e.g. see [0138]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/P.C.E/Examiner, Art Unit 3792 /AMANDA L STEINBERG/Examiner, Art Unit 3792
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