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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/20/2023 and 6/20/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant has amended claims 1, 9, 13, and 21. Claims 1-26 are currently being considered. Applicant’s arguments filed 8/19/2026, with respect to the rejection(s) of claim(s) 1, 5-13, and 17-26 under 35 U.S.C 102 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 Therefore, the rejection has been withdrawn.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 Lilliestrale et. al. (United States Patent Application Publication US 2021/0082115 A1).
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 5-13, 17-26 is/are rejected under 35 U.S.C. 103 as being obvious over Marinescu et. al. (International Patent Application Publication WO 2022/076773 A1) in view of Lilliestrale et. al. (United States Patent Application Publication US 2021/0082115 A1).
The applied reference has a common applicant (Episurf IP-Management AB) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1 and 13, Marinescu et. al. discloses a system and method for turning a patient's dysplastic or deformed patellofemoral joint into a healthier patellofemoral joint, the system comprising at least one processor arranged to: propose an improved curvature of the articulating surface of the patella and/or the femoral trochlea based on a simulated healthy surface of the curvature of an articulating surface of the patella and a simulated healthy surface of the curvature of an articulating surface of the femoral trochlea; and design one or more implants that will make the patellofemoral joint healthier by changing the curvature of at least one of the articulating surface of the patella or the articulating surface of the femoral trochlea by determining the shape and dimensions for a patellar implant that would create said improved curvature of the articulating surface of the patella, and/or a trochlear implant that would create said improved curvature of the articulating surface of the femoral trochlea (Marinescu et. al. see [0179]-[0214]; [0218], figures 8, 9A-14B, 20, Claim 1: biomechanical simulations based on the one or more implant parameters).
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However, Marinescu et. al. fails to disclose receive or retrieve image data from medical images of the patella in a patellofemoral joint; receive or retrieve image data from medical images of the femoral trochlea in said patellofemoral joint; determine whether said image data indicates damage on the patellofemoral joint; if damage on the patellofemoral joint is determined, determine if the patellofemoral joint is dysplastic or deformed, or just simply damaged; if said image data indicates that the patellofemoral joint is dysplastic or deformed.
Lilliestrale et. al. teaches receive or retrieve image data from medical images of the patella in a patellofemoral joint; receive or retrieve image data from medical images of the femoral trochlea in said patellofemoral joint; determine whether said image data indicates damage on the patellofemoral joint; if damage on the patellofemoral joint is determined, determine if the patellofemoral joint is dysplastic or deformed, or just simply damaged; if said image data indicates that the patellofemoral joint is dysplastic or deformed (Lilliestrale et. al. Abstract, Figure 7). This is important to the claimed invention because radiological images can clinically determine whether the patellofemoral joint indicates damage. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Marinescu et. al. and Lilliestrale et. al. so that the biomechanical simulations of Marinescu et. al. includes and receives the medical imaging of Lilliestrale et. al.
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Regarding claim 25, which is the non-transitory machine-readable medium on which is stored machine-readable code which, when executed by at least one processor, controls the processor to perform the method of claim 13, which the rejection analysis is incorporated herein.
Regarding claim 5 and 17, Marinescu et. al. further discloses the system according to claim 1 and method according to claim 13, wherein if there is determined to be damage to the patella, the curvature of the articulating surface of the patella that is analyzed is a simulated surface corresponding to the articulating surface that the patella would have had if it had not been damaged (Marinescu et. al. [0208] a 3D musculoskeletal model corresponding to the patient-specific information may be selected from a databased of 3D musculoskeletal models. Simulations may be performed and stored in the database such that results may be accessed without the need to perform just-in-time simulations).
Regarding claim 6 and 18, Marinescu et. al. further discloses the system according to claim 1 and method according to claim 13, wherein if there is determined to be damage to the femoral trochlea, the curvature of the articulating surface of the femoral trochlea that is analyzed is a simulated surface corresponding to the articulating surface that the femoral trochlea would have had if it had not been damaged (Marinescu et. al. [0208] a 3D musculoskeletal model corresponding to the patient-specific information may be selected from a databased of 3D musculoskeletal models. Simulations may be performed and stored in the database such that results may be accessed without the need to perform just-in-time simulations).
Regarding claim 7 and 19, Marinescu et. al. further discloses the system according to claim 1 and method according to claim 13, further comprising storage means in which example curvatures of articulating surfaces in a healthy patellofemoral joint are stored (Marinescu et. al. [0208] a 3D musculoskeletal model corresponding to the patient-specific information may be selected from a databased of 3D musculoskeletal models. Simulations may be performed and stored in the database such that results may be accessed without the need to perform just-in-time simulations).
Regarding claim 8 and 20, Marinescu et. al. further discloses the system according to claim 7 and the method according to claim 19, wherein the at least one processor is arranged to retrieve example curvatures of articulating surfaces in a healthy patellofemoral joint from the storage means, and propose an improved curvature of the articulating surface of the patella and/or the femoral trochlea based on the retrieved curvatures (Marinescu et. al. [0207]- [0208] Fig. 8, an implant position and orientation may be optimized based on the biomechanics of the joint. One or more 3D musculoskeletal models representing the patient anatomy may be used in various biomechanics simulations and responses recorded in a biomechanics database. A 3D musculoskeletal model corresponding to the patient-specific information may be selected from a databased of 3D musculoskeletal models. Simulations may be performed and stored in the database such that results may be accessed without the need to perform just-in-time simulations. The biomechanical information may be output as kinematic curves, and the biomechanics may be output as an analytic response surface, Fig. 18.).
Regarding claim 9 and claim 21, Marinescu et. al. further discloses a system for determining the shape and dimensions of at least one implant for turning a patient's dysplastic or deformed patellofemoral joint into a healthier patellofemoral joint, the system comprising at least one processor arranged to: generate a first 3D model based on a series of radiological images of the patellofemoral joint (Marinescu et. al. Claim 5: the imaging data comprises one or more of X-ray imaging data, MRI imaging data, and CT imaging data. Claim 1); determine if the first 3D model of the patellofemoral joint represents a patellofemoral joint that is dysplastic or deformed, or just simply damaged; if the first 3D model indicates that the patellofemoral joint is dysplastic or deformed, adapt the first 3D model into a second 3D model, by adapting a surface curvature of the first 3D model into a desired surface curvature based on a simulated healthy surface of the curvature of an articulating surface of the patella and a simulated healthy surface of the curvature of an articulating surface of the femoral trochlea; determine the shape and dimensions for at least one implant based on the second 3D model that will make the patellofemoral joint healthier by changing the curvature of at least one of the articulating surface of the patella or the articulating surface of the femoral trochlea by determining the shape and dimensions for a patellar implant that would create said improved curvature of the articulating surface of the patella, and/or a trochlear implant that would create said improved curvature of the articulating surface of the femoral trochlea; and ensure that all the points around the circumference of said implant in the second 3D model correspond to points on the surface of the first 3D model (Marinescu et. al. [0012]-[0020], [0208]).
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Regarding claim 10 and claim 22, Marinescu et. al. further discloses the system according to claim 9 and method according to claim 21, wherein the at least one processor is further arranged to determine the shape and dimensions for at least one guide tool based on the first 3D model (Marinescu et. al. [0073]-[0074] By tracking fiducial marks associated with that tool or bone structure, or by using other conventional image tracking modalities, a processor may track that tool or bone as it moves through the environment in a three-dimensional model).
Regarding claim 11 and 23, Marinescu et. al. further discloses the system according to claim 1 and the method according to claim 13, wherein the at least one processor is further arranged to take into account also determined damage to the patellofemoral joint when determining the shape and dimensions for a patellar implant and/or a trochlear implant (Marinescu et. al. [0205] An implant model (3D model such as a CAD model) of the selected implant may be assessed with respect to the 3D model of the patient anatomy in order to optimize fit).
Regarding claim 12 and 24, Marinescu et. al. further discloses the system according to claim 1 and method according to claim 13, wherein the at least one processor is further arranged to output said determined shape and dimensions of the implant or implants as parameters for manufacturing said implant or implants (Marinescu et. al. [0205] An implant model (3D model such as a CAD model) of the selected implant may be assessed with respect to the 3D model of the patient anatomy in order to optimize fit. The fit may be optimized by a processor based on target fit parameters, historical patient data, and/or machine learning techniques. Thereafter, the implant parameters and fit may be verified).
Regarding claim 26, which is the non-transitory machine-readable medium on which is stored machine-readable code which, when executed by at least one processor, controls the processor to perform the method of claim 21, in which the rejection analysis is incorporated herein.
Claim(s) 2-4, 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marinescu et. al. (International Patent Application Publication WO 2022/076773 A1) in view of Lilliestrale et. al. (United States Patent Application Publication US 2021/0082115 A1) as applied to claims 1 and 13 above, and further in view of Floyd et. al. (Floyd, Edward R. et al. “Medial Patellofemoral Reconstruction Using Quadriceps Tendon Autograft, Tibial Tubercle Osteotomy, and Sulcus-Deepening Trochleoplasty for Patellar Instability.” Arthroscopy Techniques 10 (2021): e1249 - e1256. (Year: 2021).
Regarding claim 2 and 14, Marinescu et. al. and Lilliestrale et. al. disclose the system according to claim 1 and method according to claim 13. However, Marinescu et. al. and Lilliestrale et. al. fails to disclose wherein the determination of whether any of said analyzed curvatures indicate that the patellofemoral joint is dysplastic or deformed involves determining whether the sulcus angle between the medial and lateral trochlear facets of the femur is larger than a threshold.
Floyd et. al. teaches wherein the determination of whether any of said analyzed curvatures indicate that the patellofemoral joint is dysplastic or deformed involves determining whether the sulcus angle between the medial and lateral trochlear facets of the femur is larger than a threshold (Floyd et. al. Objective Diagnosis, para. 1, Fig. 3). This is essential to the claimed invention because this is the clinical definition for diagnosing trochlear dysplasia. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings of Marinescu et. al., Lilliestrale et. al. and Floyd et. al. so that the clinical basis for the system is also included in the methodology.
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Regarding claim 3 and 15, Marinescu et. al., Lilliestrale et. al. and Floyd et. al. disclose the system according to claim 2 and method according to claim 14, and Floyd et. al. further discloses wherein the threshold is 145-160 degrees, preferably 145-150 degrees (Floyd et. al. Objective Diagnosis, para. 1, Fig. 3).
Regarding claim 4 and 16, Marinescu et. al., Lilliestrale et. al. and Floyd et. al. disclose the system according to claim 2 and method according to claim 14, and Floyd et. al. further discloses wherein the sulcus angle is measured in radiological images, or in a 3D model generated based on a series of radiological images (Floyd et. al. Objective Diagnosis, para. 1, Fig. 3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bojarski et. al. (United States Patent Application Publication US 2012/0209394 A1) is relevant to the claimed invention because it discloses methods and devices relating improved articular models, implant components, and related guide tools and procedures. Lang (United States Patent Application Publication US 2022/0133484 A1) is relevant to the claimed invention because it discloses devices, systems, techniques and methods for determining the fit of an implant and for determining one or more prognosticators, indicators or risk factors of postoperative performance are provided.
Response to Amendment
Examiner has carefully considered amended claims and performed an updated search. New prior arts were found to reject all amended claims 1-26.
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 JESSICA YIFANG LIN whose telephone number is (571)272-6435. The examiner can normally be reached M-F 7:00am-6:15pm, with optional day off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vu Le can be reached at 571-272-7332. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA YIFANG LIN/Examiner, Art Unit 2668 September 11, 2026
/VU LE/Supervisory Patent Examiner, Art Unit 2668
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