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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-18 and 21-22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected as indefinite for the following recitations
At line 11-12 the claim recites “the at least one visual element including a 3D model of at least one portion of the knee of the patient”. It is unclear if this recitation is meant to be a new #D model or a further recitation of the 3D model recited at lines 7-8. In the interest in compact prosecution the limitation will be interpreted as a further clarification of the same limitation.
At line 11-12 the claim recites “the at least one visual element including a 3D model of at least one portion of the knee of the patient”. This renders the claim indefinite since in lines 7-10 the claim recites a Markush grouping which includes the 3D model of the portion of the knee as one of the possible selections that can be chosen therefore, this new limitation can either be interpreted as a new 3d model or as the same model from the Markush group. In the interest in compact prosecution the limitation will be interpreted as being the same 3d model that can be selected from the Markush group and therefore, if it is not selected as the chosen visual element then these elements can then these limitations can be read out as not being needed in the claim limitations as not being applicable to the other visual elements.
Claims 2-18 and 21-22 are rejected as indefinite for depending upon an indefinite claim.
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.
Claim(s) 1-4, 7-18, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahfouz (US Patent Pub. 20170367766A1).
Mahfouz recites a method of fitting a knee prosthesis in a knee of a patient. Specifically in regards to claim 1, Mahfouz recites the method comprising: displaying, by a visual display device (200, Fig. 20/27 Para. [0138]) of a mobile augmented reality navigation system worn or carried by a user performing or assisting at least one navigation-assisted stage of the method, at least one visual element superposed on a view of at least a portion of a surgical scene of the fitting of the knee prosthesis, the at least one visual element being a 3D model of another component of the surgical scene (As can be seen in Fig. 28, is an illustration of the augmented reality system placing virtual bone and virtual components (e.g. pin guide locations) over a real world image of the exterior of a lower leg.) (Fig. 20,28, and 38; and Para. [0050]-[0053], [0131], [0151] ,[0209], [0219]-[0222]).
In regards to claim 2, Mahfouz recites wherein the at least one navigation-assisted stage of the method includes performing a manual action by the user or by a person assisted by the user, the method comprising: initiating the performance of the manual action, and modifying the performance of the manual action taking into account the at least one visual element (Para. [0022],[0131]-[0132],[0144],[0149]).
In regards to claim 3, Mahfouz recites wherein the at least one navigation-assisted stage of the method includes at least one action selected from the group consisting of: installing an articulated cutting guide on a tibia of the patient (Para. [0143]), performing a tibial cut along the tibial cutting plane (Para. [0144]), verifying the tibial cut (Para. [0144]).
In regards to claim 4, Mahfouz recites wherein the at least one navigation-assisted stage of the method includes at least two actions selected from the group (Para. [0143]-[0144]).
In regards to claim 7, Mahfouz recites wherein the at least one navigation-assisted stage of the method comprises: successively displaying, by the visual display device, a position and/or an orientation of the at least one portion of the knee of the patient or other component of the surgical scene, in each of a plurality of relative positions of the at least one portion of the knee of the patient or other component of the surgical scene (Para. [0152]).
In regards to claim 8, Mahfouz recites wherein the at least one navigation-assisted stage of the method further comprises: successively displaying, by the visual display device, simulation and/or assistance information relative to the positioning in the surgical scene of at least one portion of a surgical instrument (Para. [0149]).
In regards to claim 9, Mahfouz recites wherein the at least one navigation-assisted stage of the method further comprises: successively displaying, by the visual display device, simulation and/or assistance information relative to the positioning in the surgical scene of at least one portion of the knee prosthesis (Para, [0154]).
In regards to claim 10, Mahfouz recites wherein the at least one navigation-assisted stage of the method comprises: displaying, by the visual display device, simulation and/or assistance information relative to the positioning of at least one portion of a surgical instrument in the surgical scene (Fig. 28).
In regards to claim 11, Mahfouz recites wherein the at least one navigation-assisted stage of the method comprises: displaying, by the visual display device, simulation and/or assistance information relative to the positioning of at least one portion of the knee prosthesis in the surgical scene (Fig. 38-39).
In regards to claim 12, Mahfouz recites wherein the at least one navigation-assisted stage of the method includes fitting at least part of the knee prosthesis (Para. [0012],[0024],[0132],[0132]).
In regards to claim 13, Mahfouz recites comprising: storing, in a memory included in or connected to the navigation system, successive visual elements relative to positions and/or an orientations of the at least one portion of the knee of the patient or of the other component of the surgical scene (para. [0128]).
In regards to claim 14, Mahfouz recites comprising: displaying, by the visual display device, the successive visual elements stored in the memory (Para. [0128]).
In regards to claim 15-16, Mahfouz recites wherein at least one perception sensor is included in or connected to the navigation system, and wherein the at least one perception sensor includes at least one camera (Para.[0158]).
In regards to claim 17, Mahfouz recites wherein the mobile augmented reality navigation system includes augmented reality glasses and/or an augmented reality headset comprising the visual display device (Fig. 20 and 28).
In regards to claim 18, Mahfouz recites wherein the visual display device shows information representing and/or indicating a height of posterior condyle resections (Fig. 28), and information representing and/or indicating a size of an insert to be implanted (Para. [0132],[0156],[0161],[285]).
In regards to claim 22, Mahfouz recites at least one sensor collects successive clouds of points corresponding to surfaces of the knee of the patient (Para. [0158]-[0159],[0238],[0250]).
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) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz in view of Todorov et al (US Patent Pub. 20160278754A1).
Mahfouz recites a method comprising displaying, by a visual display device of a mobile augmented reality navigation system worn or carried by a user performing or assisting at least one navigation-assisted stage of the method, at least one visual element superposed on a view of at least a portion of a surgical scene of the fitting of the knee prosthesis, and the at least one visual element being selected from the group consisting of a 3D model of at least one portion of the knee of the patient, a 3D model of another component of the surgical scene, information relative to the at least one portion of the knee of the patient, and information relative to the other component of the surgical scene. However, the reference is silent as to a ligament tensioner.
Todorov recites a method of fitting a knee prosthesis. Specifically in regards to claims 5-6, Todorov recites wherein the at least one navigation-assisted stage of the method includes at least one action selected from the group consisting of: installing a ligament tensor (Fig. 6a/6b), measuring joint spaces under ligament tension (Fig. 8, Para. [0107],[0149],[0182],[0262], determining a configuration and a placement of a femoral implant (Fig. 8); and wherein the at least one navigation-assisted stage of the method includes: successively acquiring, by a perception sensor of the navigation system, values relative to a configuration of the ligament tensor in a plurality of relative positions of the femur and the tibia, successively displaying, by the visual display device, information relative to the configuration of the ligament tensor in each of the plurality of relative positions, and successively displaying, by the visual display device, simulation and/or assistance information relative to the configuration of the ligament tensor and/or other components of the knee prosthesis (Para. [0003], [0145], [0155], [0175], [0197], [0204], [0254]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the method of Mahfouz by adding a ligament tensor as taught in Todorov in order to address the soft tissue tensioning and balancing problems (Para. [0004]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz in view of Ferrante et al (US Patent 20220265355A1).
Mahfouz recites a method comprising displaying, by a visual display device of a mobile augmented reality navigation system worn or carried by a user performing or assisting at least one navigation-assisted stage of the method, at least one visual element superposed on a view of at least a portion of a surgical scene of the fitting of the knee prosthesis, and the at least one visual element being selected from the group consisting of a 3D model of at least one portion of the knee of the patient, a 3D model of another component of the surgical scene, information relative to the at least one portion of the knee of the patient, and information relative to the other component of the surgical scene. However, the reference is silent as the 3D model being a predefined model.
In regards to claim 21, Ferrante discloses wherein a 3D model is a pre-defined model of the at least one portion of the knee (Ferrante recites that pre-operative planning can be performed by selecting a predefined model from a group of models based on patient measurements or other clinician-selected inputs which are refined intraoperatively by measuring the patient's (i.e., target implant host's) actual anatomy.) (Para. [0200]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the method of Mahfouz by creating a 3D model as taught by Ferrante which are refined intraoperatively by measuring the patient's (i.e., target implant host's) actual anatomy (Para. [0200]).
Response to Arguments
Applicant’s amendment’s filed on 10/6/25 have overcome the previous 112 rejection of claim 18 which is now withdrawn.
Applicant's arguments filed 10/6/25 have been fully considered but they are not persuasive. Applicant argues that the Mahfouz reference relies on attaching a virtual models on to images of the actual anatomy and not a 3D model to the surgical scene as now required in the limitation. However, as is recited in the 112 rejection above claim 1 in lines 7-10 recites a Markush grouping which includes the 3D model of the portion of the knee as one of the possible selections. Then, if the 3d model of the knee is not selected from the Markush group as the visual element then the newly amended limitations can be read out as not being needed in the claim limitations as not being applicable to the other visual elements. Therefore, the continued rejection under Mahfouz is still proper.
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 MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775