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 .
Claims 1-18 are pending.
Response to Arguments
Applicants’ arguments with respect to claim(s) 1-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. USPGPUB 20170360578 A1(hereinafter “Shin”) in view of Grbic et al. USP 10710354 B2 (hereinafter “Grbic”).
As to claim 1, Shin teaches a method for creating manufacturing data for manufacturing an orthopedic device producible using the created manufacturing data in an automated manufacturing method (paragraph 0005-0006 “method for producing a prosthetic device”), comprising: providing a digital three dimensional (3D) body part model of a body part in a data processing facility (paragraph 0084-0085 “a prosthesis model can be generated based on an object model using some of the above described model”), providing at least one digital functional component model of an orthopedic functional component in the data processing facility, wherein the orthopedic functional component (paragraph 0085-0086 “a prosthesis model is generated, the process 100 continues by generating a set of instructions based on the prosthesis model (step 140)” and FIG. 1), wherein the at least one functional digital functional component model contains corresponding component properties of the respective orthopedic functional component (paragraph 0123-0124 and claim 2 “identifying supplemental data based on the received imaging data and/or the object model, wherein supplemental data comprises supplemental imaging data corresponding to body parts of one or more other patients; and updating the object model based on the imaging data and the supplemental data”),generating at least one digital component interface in the data processing facility in dependence on at least one component property of at least one selected digital functional component model of at least one selected an orthopedic functional component which is to be integrated into the orthopedic device, wherein the at least one digital component interface includes a receptacle for arranging the at least one selected orthopedic functional component (paragraph 0124-0128 “object model is generated, the process 200 continues by generating a prosthesis model based on the object model (step 240), generating a set of instructions based on the prosthesis model (step 250), and the set of instructions is executed using a 3D printer, causing the 3D printer to produce a prosthetic device for the patient (step 260). Steps 240, 250, and 260 can be similar to steps 130,140, and 150, respectively, as described above”), automatically creating a digital orthopedic model of the orthopedic device to be manufactured based on the 3D body part model and the at least one digital component interface for integration of the orthopedic functional component by the data processing facility (paragraph 085-0110 “continues by generating a set of instructions based on the prosthesis model (step 140). In an example implementation using 3D printing for fabrication, a prosthesis model can be converted into a set of printing instructions by using software specific to a destination printer and its materials” and FIG. 1-2), and generating digital manufacturing data from the created digital orthopedic model automatically created by the data processing facility (paragraph 0124-0128 and FIG. 2 “produce a prosthetic device for the patient (step 260). Steps 240, 250, and 260 can be similar to steps 130,140, and 150, respectively”).
Shin does not explicitly teach expands a functional scope of the orthopedic device by providing one or more specific functions to a prospective wearer of the orthopedic device, wherein the at least one functional digital functional component model digitally depicts an orthopedic functional component and contains corresponding component properties of the respective orthopedic functional component.
However, Grbic teaches expands a functional scope of the orthopedic device by providing one or more specific functions to a prospective wearer of the orthopedic device, wherein the at least one functional digital functional component model digitally depicts an orthopedic functional component and contains corresponding component properties of the respective orthopedic functional component (col. 6 line 24- col. 7 line 45 “patient data acquired at step 305 is used to measure and model the organ of interest in order to generate a functional specification v of the organ. The functional specification v can represent computational model parameters (e.g., geometry, mechanical properties such as tissue stiffness, etc.), clinical parameters/measurements (e.g., diameters, ejection fraction, flow, volume) or any other parameters specifying the anatomy and function of the organ. Some of these measurements may be made directly on the image data acquired at step 305. For example, the diameter of a valve may be measured in the image directly either manually or using automatic techniques generally known in the art” and FIG. 1-3).
Shin and Grbic are analogous art because they are from the same field of endeavor and contain overlapping structural and functional similarities. They both relate to prosthetic device for a patient.
Therefore at the time of effective filing date, it would have been obvious to a person of ordinary skill in the art to modify the above prosthetic device for a patient, as taught by Shin, and incorporating a functional scope of the orthopedic device by providing one or more specific functions to a prospective wearer of the orthopedic device, as taught by Grbic.
One of ordinary skill in the art would have been motivated to improve current procedural outcomes. In the case of complex anatomical deformations, such as in pediatric cases, a personalized model may be the only viable option, as suggested by Grbic (col. 1 lines 35-49).
As to claim 2, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches wherein the 3D body part model is a digital representation of the body part for which the orthopedic device is intended and which was converted into an orthopedic intended shape (paragraph 0032-0033 “geometric shape of the body part”).
As to claim 3, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches wherein a digital orthopedic model is created in a form of a volume model (paragraph 0033-0034 “cause the three-dimensional printer to produce a physical model of the body part”).
As to claim 4, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches further comprising selecting a digital mechanical interface from a plurality of provided digital mechanical interfaces in dependence on component properties of the at least one selected digital functional component model of the orthopedic device, wherein a receptacle of the selected digital mechanical interface corresponds to the at least one selected orthopedic functional component (paragraph 0124-0130 “model can be generated from an intact contralateral limb in the setting of unilateral amputation, it may be preferable to discard such a model if volumetric data of the previously intact limb is available, such as a pre-operative CT of the relevant limb”).
As to claim 5, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches wherein the generated at least one digital component interface is also generated in dependence on the 3D body part model and/or on a digital model, created from the 3D body part model, of the orthopedic device to be manufactured (paragraph 0022-0027 “generating an object model corresponding to the body part based on the first set of imaging data and the second set of imaging data”).
As to claim 6, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches further comprising, using the data processing facility, automatically a first digital orthopedic partial model of the orthopedic device to be manufactured is created based on the 3D body part model, and a second digital orthopedic partial model of the orthopedic device to be manufactured is created based on the generated digital component interface, wherein the digital orthopedic model of the orthopedic device to be manufactured is created in dependence on the first digital orthopedic model and the second digital orthopedic model (paragraph 0112-0127 “Supplemental data can then be used to update the object model or generate a new object model. An example implementation of a process 300 is shown in FIG. 3” and FIG. 1-3).
As to claim 7, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches wherein the second digital orthopedic model of the orthopedic device to be manufactured is created in dependence on the previously created first digital orthopedic model (paragraph 0104 “a digital camera to capture photographs from different perspectives relative to the arm). As another example, the patient's arm can be imaged using X-ray imaging. The acquired images are then used to create an object model of the patient's forearm” and 0173-0174).
As to claim 8, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches wherein, for each digital functional component model of an orthopedic functional component, at least one of dimensions of the component, an installation space of the component, a movement space of the component, stability properties, accesses for the installation and/or removal, tool attachments, supply lines, disposal lines, tolerable torques, occurring torques, possible functional component combinations, and thermal properties, are stored as a component property (paragraph 0097-0109 “Adjustable and/or modular components can further improve ease of and control over the degree of manipulation and frequency of adjustment, and removable components can enable more frequent and facile evaluation of the progress of correction).
As to claim 9, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches further comprising providing for visualizing one or more component properties on a playback unit of the data processing facility with or without the digital orthopedic model or a partial model thereof (paragraph 0075-0080 “identifying image segments based partially on user direction), or automatically (e.g., by a computer identifying image segments without user direction). Knowledge of the image acquisition parameters” and FIG. 1-4).
As to claim 10, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches further comprising, in dependence on at least one component property of at least one selected functional component, checking with the data processing facility whether a combination of the selected functional component and the provided 3D body part model, an orthopedic intended shape derived therefrom, and/or digital orthopedic model or partial model is producible and/or functional (paragraph 0130-0135 “object model can include re-generating the object model based on the both the imaging data and the supplemental data (e.g., as described in reference to step 230 above). In some implementations, updating the object model can include transforming the object model based on the supplemental data. For example, inclusion of radiographic data into an object model acquired by photogrammetry may reveal exaggerated bony protuberances that are partially” and Fig. 1-4).
As to claim 11, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches further comprising simulating by the data processing facility, in dependence on at least one component property of at least one selected functional component, at least one movement and/or load of the orthopedic device to be produced and/or the selected functional component (paragraph 0104-0109 and paragraph 0083-0086 “cable-pulley system or force-generating component at the joint itself, thus recreating anatomic motion”).
As to claim 12, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches further comprising creating a digital surface model of the orthopedic device to be manufactured based on the 3D body part model and a border of the orthopedic device specified on the 3D body part model by means-of the data processing facility, wherein the digital surface model forms an inside of the orthopedic device and wherein the digital orthopedic model of the orthopedic device to be manufactured is automatically created based on the digital surface model and a specified material thickness of the orthopedic device to be manufactured by the data processing facility (paragraph 0087-0092 “mechanical properties (e.g., direct fabrication of a spiral geometry of varying thickness that is more uniform and mechanically robust than an identical geometry fabricated in layers with a single extrusion rate”).
As to claim 13, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches wherein the orthopedic device producible using the created manufacturing data is an orthosis a prosthesis, or an exoskeleton (paragraph 0077 “prosthetic device (e.g., an orthosis or brace) can be modeled”).
As to claim 14, is related to claim 1 with similar limitations also rejected by same rational.
As to claim 15, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches supplying the manufacturing data to an automated manufacturing facility, wherein the automated manufacturing facility produces the orthopedic device using the created manufacturing data in an automated manufacturing method (paragraph 0160-0162 “portion of the object model that will be excised can be isolated and subsequently used to create a second prosthesis model”).
As to claim 16, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches wherein the orthopedic device produced by the automated manufacturing method of the automated manufacturing facility, is produced in dependence on the supplied manufacturing data (paragraph 0088-90 and FIG. 1-2 “produce a prosthetic device for the patient (step 150)”).
As to claim 17, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches further comprising fastening at least one functional component on a receptacle of a component interface of the orthopedic device (paragraph 0064-0066 and Fig. 1-4).
As to claim 18, Shin and Grbic teach all the limitations of the base claims as outlined above.
Shin further teaches wherein the orthosis is selected from the group consisting of a foot orthosis, a hand orthosis, a knee orthosis, a torso orthosis, and a head orthosis (paragraph 0077-0083 “manufactured (e.g., Jaipur knee/foot)”).
It is noted that any citations to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the reference should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123.
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.
Fink et al. USP 53, 70692 teaches Prosthetic bone implants are fabricated to approximately replicate a patient's original bone. Medical computer aided imaging techniques are applied to generate a data base representing the size and shape of the original bone in a three dimensional coordinate system. The implantable replica is fabricated using the data base and free form manufacturing to sequentially solidify adjoining, cross-sectional intervals of a fluid material. Appropriate fluid materials include ceramic particles which may be selectively bonded by sintering or bonding with a polymer, and a monomer which is polymerized at selected regions by an incident laser beam.
Grbic et al. USP 10710354 B2 teaches a method for generating a personalized scaffold for an individual includes acquiring images of an anatomy of interest corresponding to an intended scaffold location and acquiring test results related to the anatomy of interest. One or more functional specifications are generated based on the images and test results and one or more scaffold parameters are selected based on the functional specifications. A final scaffold may then be generated using the one or more scaffold parameters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZIAUL KARIM whose telephone number is (571)270-3279. The examiner can normally be reached on Monday-Thursday 8:00-4:00 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mohammad Ali can be reached on 571 272 4105. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZIAUL KARIM/Primary Examiner, Art Unit 2119
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