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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
Priority
This application claims priority to 63/332106 filed on April 18, 2022.
Response to Arguments
Applicant argues that Piron and Leiderman do not disclose “analyzing the surgical procedure itself to understand its temporal or procedural context.” The examiner does not take a stance on that statement. However, the claims recite “wherein the classifying and annotating predicts a surgical step that is currently being performed in real time.” While the examiner appreciates applicant’s argument, the BRI of the amendment does not require “analyzing the surgical procedure itself to understand its temporal or procedural context.” Instead, Piron discloses at ¶61-64 using intra-operative data to update surgical plans during the course of surgery. In order to update the surgical plan, the system would have predicted a surgical step of the surgery being performed in real time. Thus, Piron discloses the amendment. While the examiner appreciates that applicant seems to regard the invention as “analyzing the surgical procedure itself to understand its temporal or procedural context, that is not the only thing that the claims cover. Moreover, Piron does understand some temporal and procedural context in a surgery. The examiner suggests that applicant clarify what temporal or procedural context the invention seeks to claim.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-14 are rejected under 35 USC 103 as being unpatentable over US 2015/0351860, Piron et al. (hereafter Piron) in view of US 2022/0104884, Leiderman et al. (hereafter Leiderman)
1. A method of performing ophthalmic surgical procedures, comprising:
ingesting and preparing pre-operative data and intra-operative data associated with a patient's eye for further processing; (Piron ¶15 pre-operative information; ¶18 intraoperative image)
integrating the pre-operative data and intra-operative data to generate context sensitive data for further processing; (Piron ¶62-65 using both data inputs to update surgical plans; see e.g. ¶65 context sensitive data)
classifying and annotating the pre-operative data, the intra-operative data, and the context sensitive data, wherein the classifying and annotating predicts a surgical step that is currently being performed in real-time; (Piron ¶62-65 updates data (e.g. ¶64); ¶61-64 using intra-operative data to update surgical plans during the course of surgery. In order to update the surgical plan, the system would have predicted a surgical step of the surgery being performed in real time)
extracting one or more actionable inferences from the pre-operative data, the intra-operative data, context sensitive data, and the classified and annotated data, the classified and annotated data including the surgical step that is currently being performed in real-time; and (Piron ¶65 warns of possible puncture of a critical structure; ¶61-64 using intra-operative data to update surgical plans during the course of surgery. In order to update the surgical plan, the system would have predicted a surgical step of the surgery being performed in real time)
triggering, based on the one or more actionable inferences, one or more actions on an imaging system or a surgical system. (Piron ¶65 warns of possible puncture of a critical structure)
Piron does not explicitly disclose intra-operative data associated with a patient's eye
However, Piron ¶19 indicates this is applicable for any surgery that uses a navigation system. In another surgical area, Leiderman abstract describes a navigational system for eye surgery and thus, the invention of Piron would apply to eye surgery system of Leiderman. Thus, it would have been obvious in light of the stated applicability in Piron to utilize the teachings as applied to an eye surgery system as in Leiderman.
2. The method of claim 1, wherein the pre-operative data and intra-operative data are generated by one or more ophthalmic imaging systems, the method further comprising: receiving the pre-operative data and intra-operative data from the one or more ophthalmic imaging systems. (Piron ¶15 pre-operative information; ¶18 intraoperative image; note in eye surgery as combined with Leiderman, the imaging would be from an ophthalmic (eye) imaging system)
3. The method of claim 1, wherein integrating the pre-operative data and intra-operative data is based on time-stamps associated with the pre-operative data and time-stamps associated with the intra-operative data. (Piron ¶105 time stamps)
4. The method of claim 1, wherein the classifying and annotating further comprise performing feature extraction on the pre-operative data, the intra-operative data, and the context sensitive data using one or more trained machine learning models. (Leiderman ¶12 machine learning)
5. The method of claim 1, wherein the one or more actionable inferences include: a determination about a distance between an instrument tip and a specific landmark in the patient eye, a determination about image contrast, color, and defocus based on specific image quality metrics, or detection of a change in tasks or surgical steps within an ongoing surgical procedure. (Leiderman ¶76 distance between tip and landmark)
6. The method of claim 1, wherein the one or more actions comprise: providing image guidance; providing patient monitoring; or providing virtual assistance. (Piron ¶15 guidance)
7. The method of claim 6, wherein providing image guidance comprises flashing a code on a heads-up display of a 3D visualization system based on an inferred proximity of a surgical instrument to a specific landmark in the patient's eye. (Leiderman ¶144 warning when approaching dangerous range)
Claims 8-14 are CRM counterparts to the methods of claims 1-7 and are rejected similarly.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ming Shui whose telephone number is (303)297-4247. The examiner can normally be reached on 7-5 Pacific Time, M-Th.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Greg Morse can be reached on 571-272-38383838. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ming Shui/
Primary Examiner, Art Unit 2663