DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 April 2026 has been entered.
Claims 1-30 and 46-48 are cancelled; claims 31-45 are pending.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 09 April 2026, with respect to the rejection(s) of claim(s) 31-45 under Mahfouz 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 Therefore, the rejection has been withdrawn.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 Poltaretskyi.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 31-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poltaretskyi et al (U.S. 2019/0380792). Poltaretskyi discloses (par. 0171) a) in a planning phase prior to a surgical phase: i) a planning display device; ii) one or more planning processing devices configured to: (1) acquire scan data indicative of a scan of an anatomical part of the subject (par. 0194); (2) generate model data indicative of: (a) an anatomical part model generated using the scan data, the anatomical part model including one or more bones and key anatomical features associated with the one or more bones; (b) a surgical guide model representing a surgical guide used in positioning a surgical implant (par. 0186); (c) an implant model representing the surgical implant (par. 0171 0184 and 0194); (3) receive, from a user of the surgical system, input to change a structure of one or more of the key anatomical features of the anatomical part model (par. 0196-0197); (4) change, based on the input to change the structure of one or more of the key anatomical features of the anatomical part model, the structure of one or more of the key anatomical features of, the anatomical part model (par. 0202); (5) cause a planning visualisation to be displayed to a user using the planning display device, the planning visualisation being generated at least in part using the model data; and, (6) manipulate the planning visualisation in accordance with user input commands indicative of interaction with the planning visualisation to at least one of: (a) calculate a custom guide shape for a surgical guide (par. 0244); and, (b) at least partially plan the surgical procedure (par. 0184); and, b) in the surgical phase: i) a surgical guide configured to assist in aligning an implant with the anatomical part in use; ii) a procedure display device; and, iii) one or more procedure processing devices configured to cause a procedure visualisation to be displayed to a user using the procedure display device, the procedure visualisation being generated at least in part using the model data and being displayed whilst the surgical procedure is performed (par. 0184).
Regarding claim 32, Poltaretskyi discloses (par. 0244) the one or more planning processing devices use manipulation of the planning visualization to: a) determine an operative position of the surgical guide relative to the anatomical part; and, b) calculate the custom guide shape for the surgical guide based on the operative position.
Regarding claim 33, Poltaretskyi discloses (par. 0184) the one or more planning processing devices are configured to use user input commands to determine an alignment indicative of a desired relative position of the anatomical part model and at least one of: a) the surgical implant; and, b) a surgical tool.
Regarding claim 34, Poltaretskyi discloses (par. 0184) the at least one of: a) one or more planning processing devices are configured to determine an operative position of the surgical guide relative to the anatomical part at least in part using the alignment; b) the one or more planning processing devices are configured to determine the alignment at least in part by having a user at least one of: i) identify the key anatomical features in the representation of the anatomical part model, the alignment being determined based on the key anatomical features; and, ii) position the surgical implant relative to the anatomical part in the visualization; and, c) the planning visualization includes one or more input controls allowing a user to adjust the alignment.
Regarding claim 35, Poltaretskyi discloses (par. 0171) the one or more planning processing devices generate procedure data indicative of a sequence of steps representing progression of the surgical implant procedure and wherein the one or more planning processing devices generate the procedure data at least in part by: a) causing the planning visualisation to be displayed; b) using user input commands representing user interaction with the planning visualisation to create each step, each step being indicative of a location and/or movement of at least one of: i) the surgical tool; ii) the surgical guide; and, iii) the surgical implant; and, c) generate the procedure data using the created steps.
Regarding claim 36, Poltaretskyi discloses (par. 0177) the one or more procedure processing devices are configured to use the procedure data to: a) cause the procedure visualization to be displayed; b) determine when a step is complete in accordance with user input commands; and, c) cause the procedure visualization to be updated to display a next step.
Regarding claim 37, Poltaretskyi discloses (par. 0171) the procedure visualization is indicative of at least one of: a) the scan data; b) the anatomical part model; c) a model implant; and, d) one or more steps.
Regarding claim 38, Poltaretskyi discloses (par. 0188) the one or more procedure processing devices are configured to: a) determine a procedure display device location with respect to: i) the surgical guide; or ii) the anatomical part of the subject, wherein the one or more procedure processing devices are configured to determine the procedure display device location by at least one of: and,(1) using signals from one or more sensors;(2) using user input commands;(3) performing image recognition on captured images, the captured images being optionally captured using an imaging device associated with the procedure display device; and,(4) detecting coded data present on at least one of the surgical guide, surgical tools and the subject; and, b) cause the procedure visualization to be displayed in accordance with the procedure display device location so that: i) a visualization of the surgical guide model is displayed overlaid on the surgical guide; or ii) a visualization of the anatomical part model is displayed overlaid on the anatomical part of the subject.
Regarding claim 39, Poltaretskyi discloses (par. 0166 and 0187) a) the planning or procedure visualization includes a digital reality visualization, and wherein the one or more processing devices are configured to allow a user to manipulate visualization by interacting with at least one of: i) the anatomical part; ii) the surgical implant; iii) a surgical tool; and, iv) to surgical guide; and, b) at least one of the planning and procedure display devices is at least one of: i) an augmented reality display device; and, ii) a wearable display device.
Regarding claim 40, Poltaretskyi discloses at least (par. 0184) a prosthesis.
Regarding claim 41, Poltaretskyi discloses (par. 0332) the surgical guide includes a glenoidal guide for attachment to a glenoid of the subject, and wherein the glenoidal guide includes: a) a glenoidal guide body configured to abut the glenoid in use, the glenoidal guide body including one or more holes for use in guiding attachment of an implant to the glenoid; and, b) a number of glenoidal guide arms configured to engage an outer edge of the glenoid to secure the glenoidal guide in an operative position.
Regarding claim 42, Poltaretskyi discloses (par. 0332) at least one of: a) an underside of the glenoid body is shaped to conform to a profile of the glenoid. b) a central hole configured to receive a K-wire for guiding positioning of the implant; c) a superior hole for configured to receive a temporary K-wire used to act as an indicator of rotation and placement of the glenoid implant during insertion; and, d) an anterior hole configured to receive a surgical tool used to aid in placement and stability of the guide.
Regarding claim 43, Poltaretskyi discloses (par. 0332) the glenoidal guide arms include: a) an anterosuperior arm configured to sit and articulate inferior to the coracoid process, and extend across the glenoid vault and over the bony rim of the glenoid in use; b) an anteroinferior arm configured to sit along the anteroinferior aspect of the glenoid and glenoid vault and extend over the bony rim of the glenoid; and, c) a posterosuperior arm configured to sit on the bony glenoid rim.
Regarding claim 44, Poltaretskyi discloses (par. 0332) the surgical guide includes a humeral guide for attachment to a humerus of the subject, and wherein the humeral guide includes: a) a humeral guide body configured to extend from an articular surface of a humeral head down the bicipital groove of the humerus; and, b) a humeral guide arm configured to extend from the body and including one or more holes configured to receive surgical pins to allow for attachment of a cutting block to the humerus.
Regarding claim 45, Poltaretskyi discloses (par. 0333) an underside of the humeral guide body is shaped to conform to a profile of the humeral head.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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