CTNF 17/967,701 CTNF 88073 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) submitted on 10/17/2022 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections 07-29-01 AIA Claim 29 is objected to because of the following informalities: the limitation directed to “the knee joint for the first patient” lacks antecedent basis for “the knee” . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 29-52 are 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. The term “substantial” in claims 29 and 45 is a relative term which renders the claims indefinite. The term “substantial” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term is capable of being interpreted in various ways to those of ordinary skill in the art including varying from a fraction to 100% of the subject imaged. Therefore, the scope of the claims is unclear and are thus rendered indefinite. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 29-30, 32, 34-36, 39-46, 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Martay et al. “A preliminary modeling investigation into the safe correction zome for high tibial osteotomy” The Knee, 25, January 9, 2018, pp. 286-295 (hereinafter “Martay”, as cited by Applicant) in view of Brown et al. U.S. Publication No. 2016/0346044 (hereinafter “Brown”) . In regard to claim 29, Martay teaches A method for pre-operative planning of a high tibial osteotomy surgery, comprising: storing patient data including a 3D model representing at least a substantial portion of the tibia, femur and/or fibula of a first patient, and motion analysis data for at least the knee joint for the first patient (Page 288 Section 2.2 discloses motion analysis data being collected and recorded as well as an MRI (understood to be three dimensional imaging) of the knee of a patient. See also Appendix A Section A.1 pages 291-292 disclosing that MRI data contains 3D surfaces of the tibia, femur, patella, tibial cartilage etc. Page 292 also explicitly defines the model of bone as rigid in section A.2.) ; simulating 3D contact pressure graphs for the patient for a range of coronal and sagittal corrections and/or in a range of motions or tasks based on the 3D model and the motion analysis data (Page 289 section 3 and Fig. 3 disclose incrementally shifting pressures across the knee area. Figure 4 illustrate graphs of the pressures across cartilage and meniscal surfaces.) . However, while Martay dose disclose images of the entire patient’s leg (e.g. Figure 1) where Martay does not specifically disclose, Brown teaches and selecting an optimised high tibial osteotomy correction for the first patient; wherein the 3D model includes a whole-bone model of each of the tibia, femur and/or fibula (Brown Figure 1 element 270, Figure 2, and paragraphs [0031]-[0037] disclose and illustrate determining a surgical plan based image data including the entire bone of a patient.) . Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the teachings of Brown into that of Martay in order to provide the surgeon with options to complete a specific surgical procedure (Brown paragraph [0007]). In regard to claim 30, Martay, in view of Brown, discloses The method of claim 29, further comprising reconstructing the whole-bone model from a partial-bone model (Brown paragraphs [0026]-[0027] disclose reconstructing a 3D model based upon image data acquired of the patient. Note the motivation to combine as used in the rejection of claim 29 is applicable.) . In regard to claim 32, Martay, in view of Brown, teaches The method of claim 29, wherein the 3D model includes elements selected from the group consisting of bones, cartilage, ligaments, meniscus, muscles, and any combination thereof (Martay pages 291-292 section A.1 discloses obtaining 3D surface data of the tibia, femur, patella, tibial cartilage etc.) . In regard to claim 34, Martay, in view of Brown, discloses The method of claim 29, wherein the 3D model includes an elastic deformable model of one or more soft tissues (Martay page 292, section A.2 discloses modeling e.g. cartilage and menisci as viscoelastic materials. See also Table A.1.) . In regard to claim 35, Martay, in view of Brown, discloses The method of claim 29, wherein the 3D model includes a rigid body model of the tibia, femur and/or fibula (Martay page 292, section A.2 discloses modeling bone as rigid. See also Table A.1). In regard to claim 36, Martay, in view of Brown, discloses The method of claim 29, further comprising segmenting MRI data for the first patient to construct the 3D model (Martay pages 291-292, section A.1 discloses segmenting MRI data to obtain surface details for the tibia, femur, patella, etc.). In regard to claim 39, Martay, in view of Brown, teaches The method of claim 36, further comprising templating the segmented data to construct the 3D model (Brown Paragraphs [0069]-[0073] discloses using a 2D template, evaluated from an X-ray, to assist with identifying landmarks of a region for planning surgery. Note the motivation to combine as used in the rejection of claim 29 is applicable.) . In regard to claim 40, Martay, in view of Brown, teaches The method of claim 39, further comprising aligning the 3D model with a standing X-Ray of the first patient (Brown Paragraphs [0069]-[0073] discloses using a 2D template, evaluated from an X-ray, to assist with identifying landmarks of a region for planning surgery. Note the motivation to combine as used in the rejection of claim 29 is applicable.) . In regard to claim 41, Martay, in view of Brown, teaches The method of claim 29, further comprising articulating the 3D model according to knee joint angles calculated from the motion analysis data (Martay Page 288 section 2.2. discloses combining motion analysis and MRI data to create models during walking phases and discloses knee alignment angles of varying degrees.). In regard to claim 42, Martay, in view of Brown, teaches The method of claim 29, wherein the 3D model includes the knee joint and a selection from the group consisting of a 3D model of the proximal femur and distal tibia, the length of the femur and length of the tibia, and a location of the hip joint centre and the ankle joint centre (Martay pages 291-292 section A.1 discloses obtaining 3D surface data of the tibia, femur, patella, tibial cartilage etc.) . In regard to claim 43, Martay, in view of Brown, teaches The method of claim 29, further comprising selecting a patient specific wedge based on the optimised high tibial osteotomy correction for the first patient (Brown Paragraph [0052] and Figure 1 disclose that specific prosthesis may be designed, manufactured, or selected based on the surgery plan. Note the motivation to combine as used in the rejection of claim 29 is applicable.) . In regard to claim 44, Martay, in view of Brown, teaches The method of claim 29, further comprising using tension-compression contact modelling to estimate relative pressure between compartments of the knee (Martay Page 293 Appendix B discloses using Von Mises stresses and contact pressures being extracted from the models.) . Regarding claim(s) 45-46, the claim(s) recite(s) analogous claim limitations to that of claim 29 and is/are therefore rejected on the same premise. In regard to claim 49, Martay, in view of Brown, teaches The method of claim 45, further comprising: displaying the 3D model on a user interface; receiving input from a user via the user interface; and defining osteotomy entry and hinge points based on the received input (Brown Figures 1-2 and paragraphs [0030]-[0034] disclose a display and enabling the user to define points for the determination of a procedure. Paragraph [0028] further discloses additional data of the subject can be acquired including anatomical or physical measurements. Note the motivation to combine as used in the rejection of claim 29 is applicable.). In regard to claim 50, Martay, in view of Brown, teaches The method of claim 45, further comprising : displaying, on a user interface, 3D pressure maps for different coronal and sagittal angles (Martay Page 289 section 3 and Fig. 3 disclose incrementally shifting pressures across the knee area. Figure 4 illustrate graphs of the pressures across cartilage and meniscal surfaces.); receiving a selection of one of the 3D pressure maps via the user interface; and generating an optimised high tibial osteotomy correction for the first patient using the selected 3D pressure map, the optimised high tibial osteotomy correction including updated coronal and sagittal angles (Brown Figures 1-2 and paragraphs [0030]-[0034] disclose a display and enabling the user to define points for the determination of a procedure. Paragraph [0028] further discloses additional data of the subject can be acquired including anatomical or physical measurements. Note the motivation to combine as used in the rejection of claim 29 is applicable.). In regard to claim 51, Martay, in view of Brown teaches The method of claim 45, further comprising: displaying, on a user interface, a chart of pressures in medial and lateral tibial compartments at different coronal and sagittal wedge angles (Martay pages 289-290 and figures 3 and 4 disclose displaying pressures across surfaces of a knee joint and further determining a safe zone for a surgical procedure) ; receiving a selection of at least one of the coronal or sagittal wedge angle via the user interface (Brown Figures 1-2 and paragraphs [0030]-[0034] disclose a display and enabling the user to define points for the determination of a procedure. Paragraph [0028] further discloses additional data of the subject can be acquired including anatomical or physical measurements) ; and generating an optimised high tibial osteotomy correction for the first patient using the selected wedge angle, the optimised high tibial osteotomy correction including updated coronal and sagittal angles (Brown Figures 1-2 and paragraphs [0030]-[0034] disclose a display and enabling the user to define points for the determination of a procedure. Paragraph [0028] further discloses additional data of the subject can be acquired including anatomical or physical measurements. Figure 1 elements 274 and 218, in particular, discloses determining a plan and designing/manufacturing prosthesis for a surgery. Note the motivation to combine as used in the rejection of claim 29 is applicable.). In regard to claim 52, Martay, in view of Brown, teaches The method of claim 45, further comprising: generating a wedge design for a wedge using the optimised high tibial osteotomy correction for the first patient; and sending the wedge design to a 3D printer (Brown Figure 1 elements 274 and 218, in particular, discloses determining a plan and designing/manufacturing prosthesis for a surgery. Note the motivation to combine as used in the rejection of claim 29 is applicable) . 07-21-aia AIA Claim (s) 31 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martay in view of Brown and further in view of Haider et al. U.S. Publication No. 2016/0022374 (hereinafter “Haider”) . In regard to claim 31, Martay, in view of Brown, discloses The method of claim 30, However, where they do not explicitly teach, Haider discloses wherein the whole-bone model is reconstructed by morphing a mean bone model to fit the partial bone model (Haider Paragraph [0838] discloses using well known processes including morphing for rendering e.g. bone models for the use in computer aided surgery to develop a surgical plan.) . Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the teachings of Haider into that of Martay, in view of Brown, in order to accommodate a specific plan or procedure for an intended surgery (Haider [0838]). Regarding claim(s) 47, the claim(s) recite(s) analogous claim limitations to that of claim 31 and is/are therefore rejected on the same premise . 07-21-aia AIA Claim (s) 33 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martay in view of Brown and further in view of Donahue et al. "A Finite Element Model of the Human Knee Joint for the Study of Tibio-Femoral Contact ." ASME. J Biomech Eng . June 2002; 124(3): 273–280 (hereinafter “Donahue”) . In regard to claim 33, Martay, in view of Brown, teaches The method of claim 32. However, where they do not explicitly disclose, Donahue teaches wherein the 3D model includes a rigid body model of one or more of the cartilage, ligaments, meniscus, and/or muscles (Donahue page 276, Col. 1, discloses adding rigid surfaces to femoral cartilage and tibial cartilage in a simulation to make bones rigid for a 3D model) . Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the teachings of Donahue into that of Martay, in view of Brown, in order to improve accuracy of the three dimensional model (Donahue Abstract) and through simple substitution of one known modeling element for another to produce predictable results. Regarding claim(s) 48, the claim(s) recite(s) analogous claim limitations to that of claim 33 and is/are therefore rejected on the same premise . 07-21-aia AIA Claim (s) 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martay in view of Brown and further in view of Krause et al. WIPO International Publication No. WO 01/78015 (hereinafter “Krause” as cited in Applicant IDS) . In regard to claim 37, Martay, in view of Brown, teaches The method of claim 36 However, where they fail to explicitly disclose, Krause teaches further comprising finer-scale morphing at the proximal and distal femur regions using a local morphing method (Krause page 25 lines 4-24 and page 26 line 21 through page 27 line 13 disclose a deformable model used to create a 3D model based off of 2D X Ray image data. See also Figures 13 and 14.) . Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate the teachings of Krause into that of Martay, in view of Brown, in order to have the 3D model match that of the patient’s 2D image data. In regard to claim 38, Martay, in view of Brown and Krause, teaches The method of claim 37, further comprising region mapping including automatically assigning boundary conditions and/or load to each region (Martay page 292 section A.2 discloses subject specific geometries and loads used to create models of the bones, cartilage, menisci, etc..) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN K MCINNISH whose telephone number is (571)270-1089. The examiner can normally be reached Monday - Friday 9 am - 6 pm (Flexible Fridays). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KEVIN K MCINNISH/Primary Examiner, Art Unit 6221 Application/Control Number: 17/967,701 Page 2 Art Unit: 6221 Application/Control Number: 17/967,701 Page 3 Art Unit: 6221 Application/Control Number: 17/967,701 Page 4 Art Unit: 6221 Application/Control Number: 17/967,701 Page 5 Art Unit: 6221 Application/Control Number: 17/967,701 Page 6 Art Unit: 6221 Application/Control Number: 17/967,701 Page 7 Art Unit: 6221 Application/Control Number: 17/967,701 Page 8 Art Unit: 6221 Application/Control Number: 17/967,701 Page 9 Art Unit: 6221 Application/Control Number: 17/967,701 Page 10 Art Unit: 6221 Application/Control Number: 17/967,701 Page 11 Art Unit: 6221 Application/Control Number: 17/967,701 Page 12 Art Unit: 6221