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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 16th 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
This is in response to applicant’s amendment/response filed on April 21st 2026 which have been entered and made of record.
Applicant’s arguments regarding claim rejections under 35 U.S.C 102 have been fully considered but they are not persuasive.
Applicant argues Casey fails to disclose the above features of independent claim 1. For example, page 6 of the Office Action cites to paragraphs [0024] and [0025] of Casey as disclosing "generating, based on the medical image data and the planning data, an image comprising a representation of the at least one anatomical element" and cites to [0027] and [0170] of Casey as disclosing "in a pose defined by the at least three planned positions." The present application discloses causally generating an image that depicts the pose of the anatomical representation based on the at least three planned positions. In contrast, Casey merely discloses intraoperative images overlaid onto a planned image.
Specifically, Casey describes a generation of virtual models and visualization of anatomical structures using surgical planning software. Intraoperative images can be obtained and overlaid onto planned or target images "to determine whether the implant is positioned according to the pre-surgical plan." See Casey, Paras. [0024] and [0025]. Visualizing anatomical structures by overlaying intraoperative images onto planned images differs from generating an image in which the pose of the anatomical element is defined by at least three planned positions.
Further, Casey discusses displaying the location of patient-specific implants in the case of a spinal-cord procedure. The implant locations are merely planning targets within the anatomy to be displayed, as shown in Fig. 13 of Casey. However, the spinal column displayed in Fig. 13 is not orientated in a pose that is defined by pre-planned locations such as implant positions. In fact, Casey fails to disclose the figure is a generated image. Rather, Casey states the figure illustrates "a segment of a patient's spine after several patient-specific implants have been implanted therein." As such, Casey does not illustrate a generated representation of an anatomical element, rather, it discloses merely an example of a patient's spine after several patient-specific implants have been implanted. Therefore, Casey fails to disclose or fairly suggest generating, based on the medical image data and the planning data, an image comprising a representation of the at least one anatomical element in a pose defined by the at least three planned positions.
Furthermore, Casey is directed to generating and implementing surgical plans based not only on preoperative patient data of the patient to be operated on, but also incorporating information from "reference patient data sets." See Casey, para. [0040]. Casey discloses potentially generating and implanting a patient-specific implant using additive manufacturing. See Casey, para. [0072]. The user can obtain a "patient dataset" and can create a "virtual model of the patient's native anatomical configuration." See Casey, para. [0106]. A "virtual model of a corrected anatomical configuration for the patient" can be created. See Casey, para. [0108]. Then, a surgical plan for achieving the corrected anatomical configuration shown by the virtual model can be generated. See Casey, para. [0111]. The surgical plan is transmitted for surgeon review for approval, rejection, or modification See Casey, paras. [0112] and [0113]. Following approval, a patient-specific implant is designed and manufactured using additive manufacturing and implanted into the patient. See Casey, paras. [0113]- [0120]). In sum, Casey does not disclose or fairly suggest a display of a representation of patient anatomy at a specific pose. Rather, Casey merely discloses an end to end pipeline for designing and placing a custom implant based on the data from previous patients.
In contrast, the present application discloses a generated image in which the planned medical implant has a desired orientation relative to the vertical and horizontal image axis, which may also depict the associated at least one anatomical element in a desired pose. Furthermore, "as the orientation is derived from planned positions indicated by planning data, no computationally expensive segmentation or image recognition algorithms may need to be employed to align the anatomical element in the preferred orientation." See, Detailed Description, Para. [0093]. In other words, the present features disclose a generated image that depicts the pose of the anatomical representation in the generated image in a manner that is causally connected to the three planned positions. As such, Casey fails to disclose "generating, based on the medical image data and the planning data, an image comprising a representation of the at least one anatomical element in a pose defined by the at least three planned positions."
Examiner respectable disagrees Casey teaches a variety of medical image data, such as pre-operatively generated surgical plans, intra-operative images, interactive surgical plan, and target images generated from virtual models of the anatomical element (Para. 0024-0025). All of the medical images showcase an anatomical element, specifically the spine of a human body (Fig. 10A, 10B, 10C). Thus Casey teaches obtaining medical image data of at least one anatomical element of a patient's body. Casey further teaches a variety of planning data, such as pre-operatively planned images, the interactive surgical plan, and target images generated from virtual models of the anatomical element (Para. 0024-0025). Each of the planning data include multiple planned positions indicating the location of implants in a spine (Para. 0027 and 0170, Fig. 8A, Fig. 9A-1, and Fig. 9A-2). Thus Casey teaches obtaining planning data indicative of at least three planned positions associated with the at least one anatomical element, wherein one or more of the planned positions are associated with at least one planned medical implant. Casey also teaches an interactive surgical plan (Fig. 10A) that contain various different images, such as Pre-op Images, Intra-op Images, and Images generated from several different virtual models (Para. 0078). The virtual models can represent the spine in the pre-operative anatomical configuration and corrected anatomical configuration (Para. 0013, 0014, and 0078, Figs. 8-10). The treatment planning module 118 can generate images of these virtual models (Para. 0078). These virtual models are generated based on images of the patient anatomy, images from the surgical plan (Para. 0024), and even the intra-operative data (Para. 0029). Thus, Casey teaches generating, based on the medical image data (Images of Patient Anatomy) and the planning data (Images of Surgical Plan), an image (Images from Virtual Models ) comprising a representation of the at least one anatomical element (Spine) in a pose (Pre-operative or Corrected Anatomical Configuration) defined by the at least three planned positions (Planned Implant Positions).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are:
Medical image acquisition unit in claim 19. Being interpreted as a fluoroscopic imaging device, a C-arm scanner, MR scanner, X-ray Apparatus. (Page 7, Lines 29-32 and Page 8, Lines 32-33)
Display unit in claim 19. Being interpreted as a screen, an augmented reality (AR) display, a head-mounted (e.g., augmented reality) display (HMD) or a tablet computer. (Page 13, Lines 5-7)
Because these claim limitation(s) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 7-8, 10, and 12-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Casey et al. U.S. Patent Application Publication 20240261029 A1 (hereinafter Casey).
Regarding claim 1, Casey teaches a method for generating an image (Pre-operatively Planned Images, Target Images, and Virtual Models, Para. 0024-0025) including a representation of an anatomical element (Patient Anatomy and Anatomical Features, Para. 0024-0025) of a patient’s body, the method being performed by a computing system (Computing Device 200, Para. 0083, 0085, and 0088) and comprising:
obtaining medical image data (Pre-operatively Planned Images, Target Images, Virtual Models, and Intra-Operative Images, Para. 0024-0025) of at least one anatomical element (Patient Anatomy and Anatomical Features, Para. 0024-0025) of a patient’s body; As stated above, Casey teaches a variety of medical image data, such as pre-operatively generated surgical plans, intra-operative images, interactive surgical plan, and target images generated from virtual models of the anatomical element (Para. 0024-0025). All of the medical images showcase an anatomical element, specifically the spine of a human body (Fig. 10A, 10B, 10C). Thus Casey teaches obtaining medical image data of at least one anatomical element of a patient's body.
obtaining planning data (Pre-operatively Planned Images or Surgical Plan, Para. 0024-0025) indicative of at least three planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) associated with the at least one anatomical element (Spinal Cord Region), wherein one or more of the planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027)are associated with at least one planned medical implant (Patient Specific Implants 1300a-1300c); (Fig. 13 and Para. 0170) As stated above, Casey further teaches a variety of planning data, such as pre-operatively planned images, the interactive surgical plan, and target images generated from virtual models of the anatomical element (Para. 0024-0025). Each of the planning data include multiple planned positions indicating the location of implants in a spine (Para. 0027 and 0170, Fig. 8A, Fig. 9A-1, and Fig. 9A-2). Thus Casey teaches obtaining planning data indicative of at least three planned positions associated with the at least one anatomical element, wherein one or more of the planned positions are associated with at least one planned medical implant.
and generating, based on the medical image data(Pre-operatively Planned Images, Target Images, Virtual Models, and Intra-Operative Images, Para. 0024-0025) and the planning data(Pre-operatively Planned Images or Surgical Plans, Para. 0024-0025), an image (Generated Pre-operatively Planned Images Based Patient Data and Virtual Models, Para. 0024) comprising a representation of the at least one anatomical element(Patient Anatomy and Anatomical Features, Para. 0024-0025) in a pose (Position or Orientation) defined by the at least three planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027). Casey also teaches an interactive surgical plan (Fig. 10A) that contain various different images, such as Pre-op Images, Intra-op Images, and Images generated from several different virtual models (Para. 0078). The virtual models can represent the spine in the pre-operative anatomical configuration and corrected anatomical configuration (Para. 0013, 0014, and 0078, Figs. 8-10). The treatment planning module 118 can generate images of these virtual models (Para. 0078). These virtual models are generated based on images of the patient anatomy, images from the surgical plan (Para. 0024), and even the intra-operative data (Para. 0029). Thus, Casey teaches generating, based on the medical image data (Images of Patient Anatomy) and the planning data (Images of Surgical Plan), an image (Images from Virtual Models ) comprising a representation of the at least one anatomical element (Spine) in a pose (Pre-operative or Corrected Anatomical Configuration) defined by the at least three planned positions (Planned Implant Positions).
Regarding claim 2, Casey teaches the method of claim 1, wherein the image (Pre-operatively Planned Images, Target Images, and Virtual Models, Para. 0024-0025) is generated such that two or more of the at least three planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) lie in a same plane (Para. 0126 and 0136) corresponding to or being parallel to an image plane of the generated image. (Fig. 10B, Fig 8A) The Images Generated can be modified/generated to be viewed from various angles/orientations. Thus, the planned positions can be in the same plane as the image plane. See Fig. 10B the Implant locations (screws) are in the same plane as the spine.
Regarding claim 3, Casey teaches the method of claim 1, wherein two or more of the planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) are associated with a same planned medical implant. (Para. 0024-0025, and 0141) Implants have multiple planned positions associated with them. As the entirety of an implant needs to be tracked to ensure the implant is in the correct position. For example, when inserting a screw into a spine, the location at the tip of the screw and the top would be different locations relative to the spine. Both locations would be associated with the same screw. See Fig. 8B, Fig.10B and Fig. 10D
Regarding claim 5, Casey teaches the method of claim 3, wherein at least three of the planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) associated with the same planned medical implant(Patient Specific Implants 1300a-1300c) lie in a plane defining an orientation (Para. 0136 and 0153) of the same planned medical implant. (Fig. 8B, Fig.10B and Fig. 10D)
Regarding claim 7, Casey teaches the method of claim 2, wherein the image (Pre-operatively Planned Images, Target Images, and Virtual Models, Para. 0024-0025) is generated such that a plurality of the planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) associated with the same planned medical implant lie in a same plane (Para. 0126 and 0136) corresponding to or being parallel to the image plane of the generated image. (Fig. 10B, Fig 8A)
Regarding claim 8, Casey teaches the method of claim 1, wherein the at least three planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) comprise at least two pairs of planned positions (Multiple Locations along an Implant), each pair being associated with a different planned medical implant. (Para. 0169-0170) Some procedures may require several implants to achieve a desired outcome from a surgery. Para. 0170. As well as implants may consist of several parts, such as multiple screws. Para. 0116 Thus, if a screw has multiple locations associated with it, those locations would consist of a pair of planned positions.
Regarding claim 10, Casey teaches the method of claim 8, wherein the image is generated such that the planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) of the at least two pairs of planned positions (Multiple Locations along an Implant) lie in a same plane (Para. 0126 and 0136) corresponding to or being parallel to an image plane of the generated image. (Fig. 8B, Fig.10B and Fig. 10D)
Regarding claim 12, Casey teaches the method of claim 1, wherein the medical image data (Virtual Model, Apra. 0024) comprises volumetric image data (Images from X-Ray, CT, MRI, Para. 0134) and the image is generated as a two-dimensional (Para. 106) image representative of a cross-section(Cross-Section 802/804/806 Para. 0136) of the volumetric image data. The generated virtual model is generated based on various Image data of the Patient, Para. 0069.
Regarding claim 13, Casey teaches the method of claim 1, wherein the generated image (Pre-operatively Planned Images, Target Images, and Virtual Models, Para. 0024-0025) comprises a representation of at least a portion (Lower Spinal Cord Region) of the at least one planned medical implant(Patient Specific Implants 1300a-1300c, Para. 0170). (Fig 10C and Fig. 13)
Regarding claim 14, Casey teaches the method of claim 1, wherein the medical implant (Patient Specific Implants 1300a-1300c) comprises at least one component selected from (i) a spinal cage, (Cages, Para. 0064) (ii) a bone screw such as a pedicle screw (Screws, Para. 0064), (iii) a pedicle fixation hook and (iv) a pedicle fixation band; and/or wherein the at least one anatomical element (Spinal Cord Region) comprises a bone such as a vertebra. (Para. 0170)
Regarding claim 15, Casey teaches the method of claim 1, further comprising triggering display (Display 122, Para. 0068) of the generated image (Pre-operatively Planned Images, Target Images, and Virtual Models, Para. 0024-0025).
Regarding claim 16, Casey teaches the method of claim 1, further comprising obtaining user input (User Input to Modify Surgical Plan or Interact with Images, Para. 0024 and 0078) indicative of a selected one of the at least one anatomical element (Patient Anatomy and Anatomical Features, Para. 0024-0025), wherein the image (Pre-operatively Planned Images, Target Images, and Virtual Models, Para. 0024-0025) is generated based on the at least three planned positions(Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) associated with the selected anatomical element(Zooming or Cropping of Lower Spinal Cord Region). (Fig 10C and Fig. 13) A user can modify a virtual model to be generated of a specific region or orientated in a specific way.
Regarding claim 17, Casey teaches the method of claim 16, wherein a plurality of images(Pre-operatively Planned Images, Target Images, and Virtual Models, Para. 0024-0025) is generated based on the medical image data (Pre-operatively Planned Images, Target Images, Virtual Models, and Intra-Operative Images, Para. 0024-0025) and the planning data(Pre-operatively Planned Images or Surgical Plan, Para. 0024-0025), each image being generated based on at least three of the planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) associated with a same respective anatomical element (Patient Anatomy and Anatomical Features, Para. 0024-0025), and only the image generated based on the at least three of the planned positions (Multiple Implant Locations, Para. 0170 or Anatomical Configuration Positions Para. 0027) associated with the selected anatomical element (Patient Anatomy and Anatomical Features, Para. 0024-0025) is triggered to be displayed. A user could choose to only display images with three planned positions.
Regarding claim 18, Casey teaches a system comprising at least one processor (Processors 210, Para. 0034 and 0083) configured to perform the method of claim 1 which has similar limitations as of claim 1, therefore it is rejected under the same rationale as claim 1.
Regarding claim 19, Casey teaches the system according to claim 18, further comprising at least one of the following components:
a medical image acquisition unit (Imaging Devices, Para. 0025 and 0086) configured to generate the medical image data (Intra-Operative Images, Para. 0124 or Other Image Data, Para. 0149);
a user input device (Input Devices 220, Para. 0085) configured to acquire user input; (Para. 0084)
and a display (Display 230) unit configured to display at least the generated image. (Para. 0085)
Regarding claim 20 , Casey teaches a computer program (Program Instructions, Para. 0083) stored on non-transitory computer readable medium (Memory 250, Para. 0088) and comprising instructions which, when executed on at least one processor (Processors 210, Para. 0034 and 0083), cause the at least one processor (Processors 210, Para. 0034 and 0083) to perform the method of claim 1 which has similar limitations as of claim 1, therefore it is rejected under the same rationale as claim 1.
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) 4, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Casey et al. U.S. Patent Application Publication 20240261029 A1 (hereinafter Casey) in view of Tolkowsky et al. IDS REF- WIPO WO 2022079715 A1 (hereinafter Tolkowsky).
Regarding claim 4, Casey fails to teach the method of claim 3, wherein at least two of the planned positions associated with the same planned medical implant lie on a straight line defining an orientation of the same planned medical implant.
Casey and Tolkowsky are analogous to the claimed invention because both of them are in the same field of determining the positions of implants in patients through images.
Tolkowsky teaches the method of claim 3, wherein at least two of the planned positions associated with the same planned medical implant (Pedicle Screws, Page 47, Step 5) lie on a straight line (Diagonal Tool-Insertion Lines 242) defining an orientation of the same planned medical implant. (Page 46, Para. 3 and Para. 6 , Fig. 12K or 13B) Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Casey’s Image to incorporate Tolkowsky’s Orientation Lines associated with Implants. Since doing so would provide the benefit of highlighting the orientation of implants to increase the accuracy of the surgical plans. As well as making it easier to compare the surgical plans and the post op images to ensure the implants are in the correct locations.
Regarding claim 6, Casey fails to teach the method of claim 4, wherein the image is generated by orienting the representation of the at least one anatomical element such that an angle between (i) a line indicating the orientation of the same planned medical implant, and (ii) a vertical or horizontal image axis of the generated image fulfils at least one predefined criterion.
However, Tolkowsky teaches the method of claim 4, wherein the image is generated by orienting the representation of the at least one anatomical element (Specific Vertebra, Page 47, Step 1) such that an angle (Page 47, Step 9 and Step 11) between (i) a line(Diagonal Tool-Insertion Lines 242) indicating the orientation of the same planned medical implant (Pedicle Screws, Page 47, Step 5), and (ii) a vertical (Vertical Line 240) or horizontal image axis of the generated image fulfils at least one predefined criterion (Selecting the most suitable Axial Cross-Section, Page 47, Step 5). (Page 46, Para. 3 and Para. 6 , Fig. 12K or 13B) Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Casey’s Image to incorporate Tolkowsky’s Orientation Lines and Axes. Since doing so would provide the benefit of highlighting the orientation of implants to increase the accuracy of the surgical plans. As well as making it easier to compare the surgical plans and the post op images to ensure the implants are in the correct locations.
Regarding claim 9, Casey fails to teach the method of claim 8, wherein the planned positions of each pair of planned positions lie on a straight line defining an orientation of the planned medical implant associated with that pair.
However, Tolkowsky teaches the method of claim 8, wherein the planned positions of each pair of planned positions (Insertion Points 244 and Incision Sites 235) lie on a straight line (Diagonal Tool-Insertion Lines 242) defining an orientation of the planned medical implant (Pedicle Screws, Page 47, Step 5) associated with that pair. (Page 46, Para. 3, Fig. 12K) Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Casey’s Image to incorporate Tolkowsky’s Orientation Lines associated with Implant Positions. Since doing so would provide the benefit of highlighting the orientation of implants to increase the accuracy of the surgical plans. As well as making it easier to compare the surgical plans and the post op images to ensure the implants are in the correct locations.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Casey et al. U.S. Patent Application Publication 20240261029 A1 (hereinafter Casey) in view of Tolkowsky et al. IDS REF- WIPO WO 2022079715 A1 (hereinafter Tolkowsky) in further view of Mcguan et al. WIPO WO 2020163358 A1 (hereinafter Mcguan).
Regarding claim 11, Casey and Tolkowsky fail to teach the method of claim 8, wherein the image is generated by orienting the representation of the at least one anatomical element such that an angle between (i) an angle bisector that bisects an angle between lines indicating orientations of the different medical implants and (ii) a vertical or horizontal image axis of the generated image fulfils at least one predefined condition.
Casey, Tolkowsky and Mcguan are analogous to the claimed invention because all of them are in the same field of generating images of planned implants.
Mcguan teaches the method of claim 8, wherein the image is generated by orienting the representation of the at least one anatomical element (Patient Hip, Page 58 Para. 0314 and 0315) such that an angle between (i) an angle bisector (Perpendicular Line 2134, Page 58 Para. 0317) that bisects an angle (Bisection Points 2152, and 2152, Page 58 Para. 0317) between lines indicating orientations (Page 64 Para. 0334) of the different medical implants and (ii) a vertical or horizontal image axis (Horizontal Line 2132 and 2144, Page 58 Para. 0317) of the generated image fulfils at least one predefined condition (Optimal Implantation Features, Page 64 Para. 0344). (Fig. 23A and 23B) Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Casey’s Image altered by Tolkowsky’s Lines to corporate Mcguan’s Simulation to Find Implantation Angles based on a Patients Geometry. Since doing so would provide the benefit of finding all possible implant locations to determine the best position for an implant based on characteristics set by a user. (Mcguan, Page 60 Para. 0325)
Conclusion
THIS ACTION IS MADE FINAL. 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 BRIANNA R COCHRAN whose telephone number is (571)272-4671. The examiner can normally be reached Mon-Fri. 7:30am - 5:00pm.
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/BRIANNA RENAE COCHRAN/Examiner, Art Unit 2615
/ALICIA M HARRINGTON/Supervisory Patent Examiner, Art Unit 2615
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