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.
Joint Inventors
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Information Disclosure Statement
The file wrapper contains 5 separate IDS documents, all marked as considered by the Examiner of record. However, in order of submission, those 5 IDS’s contain the following allegedly relevant references:
(1) 1 NPL, 24 Foreign, 98 PGPubs, 172 Patents - 27 June 2025
(2) 2 Foreign - 15 December 2025
(3) 2 Foreign - 5 February 2026
(4) 1 Foreign - 5 May 2026
(5) 2 PGPubs - 11 June 2026
In total, this compilation likely totals thousands upon thousands of pages to potentially review. In accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), stating that forcing the Examiner to find "a needle in a haystack" is "probative of bad faith." Id. [The Molins] case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Likewise, the instant application’s IDSs include way more than even what was found to be excessive in the Molins case, and these IDSs do not include any concise explanation of the relevance of any of the listed references nor cite any pages, columns, and lines (or paragraph numbers) where relevant passages or relevant figures appear. According to MPEP Section 2004 “Aids to Compliance With Duty of Disclosure [R-08.2012]”, “It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of most significance.” Additionally, per MPEP Section 609.04(a)(III): “applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.” See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v.Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
As such, even though these IDSs have been placed in the application file with the lists of references marked as considered, and the compilation of those listed US Patents and Pre-Grant Publications have at least been key-word searched and/or classification searched for relevant prior art, and the compilation of foreign and/or NPL references have at least been briefly reviewed (for example, abstracts and drawings reviewed), the information referred to therein for each individual reference has admittedly been considered only within the reasonable time period allocated by the Examiner out of the total normal examination time given for any given application with a similar classification picture. If Applicant wishes to have one or more references considered more in depth, the Examiner requests resubmitting the IDSs with a reasonable number of references that are known to be pertinent for the determination of patentability as defined by 37 C.F.R. § 1.56, along with the concise explanations as to relevance and citations explaining the locations of relevant passages or figures, as per 37 CFR 1.98(a)(3) and 37 CFR § 1.105.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being obvious over McKinnon et al. (US Patent Pub. No. 2022/0273281 A1), herein “McKinnon”, filed August 7th, 2019, in view of Kang et al. (US Patent Pub. No. 2012/0209419 A1), herein “Kang”, and further in view of Rosenburg (US Patent Pub. No. 2005/0101970 A1).
Regarding Claims 1, 10 and 19, McKinnon discloses a method and surgical system (See Abstract, “Methods and systems for planning a joint replacement surgical procedure […]”), comprising:
(per Claim 10 only) providing a graphical user interface configured to facilitate planning a planned pose of an implant cup (See 0031, “[…] graphical user interfaces including images depicting an implant placement […]” See also 0098, “[…] the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan would impact the procedure and the final position and orientation of implants […]”);
positioning the implant cup using a robot (See 0065, “[…] impactor that is attached or connected to the robotic arm 105A or end effector 105B to impact trial implants and final implants into the acetabulum. The robotic arm 105A and/or end effector 105B can be used to guide the impactor to impact the trial and final implants into the acetabulum in accordance with the surgical plan.”);
checking, prior to impaction and using a trackable probe, an actual pose of the implant cup relative to the planned pose (See 0055, “[…] registers the CASS 100 to the relevant anatomy of the patient can also involve the use of anatomical landmarks, such as landmarks on a bone or cartilage […] can include a 3D model of the relevant bone or joint and the surgeon can intraoperatively collect data regarding the location of bony landmarks on the patient's actual bone using a probe that is connected to the CASS […] compare and register the location data of bony landmarks collected by the surgeon with the probe with the location data of the same landmarks in the 3D model.” See also 0065, “[…] cause the position and orientation of the trial and final implants vis-à-vis the bone to be displayed to inform the surgeon as to how the trial and final implant's orientation and position compare to the surgical plan […]” See also 0067, “[…] number and types of anatomical landmarks that are checked and captured and/or the location and number of tracker arrays used […]”); and
performing the impaction of the implant cup (See 0072, “[…] during insertion of a prosthetic acetabular cup with a powered impaction device, the device may automatically extend an impaction head (e.g., an end effector) moving the implant into the proper location […]”).
But does not explicitly disclose planning a planned pose of an implant cup, wherein the planning comprises planning screw trajectories associated with the implant cup.
Kang, in a similar field of endeavor, teaches planning a planned pose of an implant cup (See 0024, “[…] the controller 110 may be configured to plan a pose to implant the acetabular cup 22 into a patient's pelvis 10. As used herein, “pose” means position and orientation. The acetabular cup 22 may have an acetabular cup axis 23 associated with it. The acetabular cup axis 23 may be pass through the center of the acetabular cup 23, and may be substantially normal to the center of the acetabular cup 23 and/or the rim of the acetabular cup 23.”).
Rosenburg, in a similar field of endeavor, teaches the planning comprises planning screw trajectories associated with the implant cup (See 0011, “[…] Image-guided fine surgery, as described above, has been directed to calculating bone density for screw path optimization.” See also 0014, “[…] screw trajectories with configurable inner and outer diameters, generally describing a hollow cylinder.”).
In view of Kang and Rosenburg’s teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include, with the robotic implant planning and placement techniques as disclosed by McKinnon, the implant pose planning operation from Kang and the screw trajectory planning process from Rosenburg, with a reasonable expectation of success, since the combination would provide a more comprehensive preoperative and intraoperative planning workflow to optimize both implant placement and fixation. Furthermore, such a combination merely applies known image-guided screw trajectory optimization techniques to a known robotic acetabular implant planning system to improve the quality of fixation while reducing the likelihood of undesired or suboptimal screw placements.
Regarding Claims 2 and 11, McKinnon further discloses the method of Claims 1 and 10, wherein using the trackable probe comprises touching the implant cup with the trackable probe (See 0055, 0065 and 0067 as referenced above).
Regarding Claims 3 and 12, McKinnon further discloses the method of Claims 1 and 10, wherein using the trackable probe comprises touching a bone with the trackable probe (See 0055, 0065 and 0067 as referenced above).
Regarding Claims 4, 13 and 20, McKinnon further discloses the method of Claims 1 and 10 and surgical system of Claim 19, further comprising modifying the actual pose to bring the actual pose into alignment with the planned pose based on the checking (See 0065 as referenced above and also, “[…] provide the surgeon with the option of re-planning and re-doing the reaming and implant impaction by preparing a new surgical plan if the surgeon is not satisfied with the original implant position and orientation.”).
Regarding Claims 5 and 14, McKinnon does not explicitly disclose the method of Claims 1 and 10, further comprising orienting a model of the implant cup in virtual space based on a trackable position of the trackable probe.
Kang, in a similar field of endeavor, teaches orienting a model of the implant cup in virtual space based on a trackable position of the trackable probe (See 0024, “[…] may position a virtual model of the acetabular cup 22 relative to the medical image of the patient's pelvis […]”).
In view of Kang’s teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include, with the robotic implant planning and placement techniques as disclosed by McKinnon, virtual implant positioning models and orientations, with a reasonable expectation of success, since both references are directed to computer-assisted hip arthroplasty planning and execution, and their combination would predictably improve the accuracy and consistency of robotic acetabular cup placements through the use of known navigation and planning techniques for implant positioning.
Regarding Claims 6 and 15, McKinnon does not explicitly disclose the method of Claims 1 and 10, wherein planning the screw trajectories comprises interacting with a graphical user interface comprising a visualization of the screw trajectories relative to bone density.
Rosenburg, in a similar field of endeavor, teaches planning the screw trajectories comprises interacting with a graphical user interface comprising a visualization of the screw trajectories relative to bone density (See 0002, “[…] utilize intraoperative image-guidance for real-time visualization of non-anatomic bone properties, such as bone density, allowing functional screw path optimization […]” See also 0010, “[…] calculate bone density in potential paths through which the screw will pass.” See also 0014-0015, “The most effective screw trajectory depending upon bone density and other factors will be chosen and can be calculated […] software displays, real-time, the average bone density and aggregate bone density for this cylinder. These values are used to select a screw path optimized for pullout strength.”).
In view of Rosenburg’s teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include, with the robotic implant planning and placement techniques as disclosed by McKinnon, screw trajectory planning and bone density-based optimization techniques, with a reasonable expectation of success, since the combination would improve fixation planning by selecting screw trajectories based on patient-specific bone qualities while avoiding undesirable trajectories. Doing so would have predictably enhanced implant stability and surgical planning using known image-guided optimization within an existing robotic surgical platform.
Regarding Claims 7 and 16, McKinnon does not explicitly disclose the method of Claims 1 and 10, wherein planning the screw trajectories comprises assessing the screw trajectories associated with the implant cup relative to other screw trajectories using a graphical user interface.
Rosenburg, in a similar field of endeavor, teaches planning the screw trajectories comprises assessing the screw trajectories associated with the implant cup relative to other screw trajectories using a graphical user interface (See 0002, 0010 and 0014-0015 as referenced above).
In view of Rosenburg’s teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include, with the robotic implant planning and placement techniques as disclosed by McKinnon, screw trajectory planning based on assessment of multiple potential screw trajectories, with a reasonable expectation of success, since the combination would improve fixation planning by selecting screw trajectories based on comparison with multiple screw trajectories to determine and avoid undesirable trajectories. Doing so would have predictably enhanced implant stability and surgical planning using known image-guided optimization within an existing robotic surgical platform.
Regarding Claims 8 and 17, McKinnon does not explicitly disclose the method of Claims 1 and 10, wherein planning the screw trajectories comprises preventing interference between a screw trajectory and planned or existing hardware.
Rosenburg, in a similar field of endeavor, teaches planning the screw trajectories comprises preventing interference between a screw trajectory and planned or existing hardware (See Abstract, “[…] display means to determine such properties as bone density or obstructions to surgical instrument movement […] enhances the surgical procedure by ensuring desirable screw placement optimized for pullout strength or using SPECT to determine minimally-invasive surgical paths.”).
In view of Rosenburg’s teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include, with the robotic implant planning and placement techniques as disclosed by McKinnon, screw trajectory planning based on interference prevention from a physical component, with a reasonable expectation of success, since the combination would improve fixation planning by selecting screw trajectories based on potential collision or interference with existing physical system components to determine and avoid undesirable trajectories. Doing so would have predictably enhanced implant stability and surgical planning using known image-guided optimization within an existing robotic surgical platform.
Regarding Claims 9 and 18, McKinnon further discloses the method of Claims 1 and 10, wherein performing the impaction of the implant cup comprises operating the robot such that the robot positions an impaction device based on the planned pose of the implant cup (See 0065 and 0072 as referenced above. See also 0083, “[…] the robotic arm 105A may be used to hold a cup impactor at a desired angle or orientation during cup impaction.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bryant Tang whose telephone number is (571)270-0145. The examiner can normally be reached M-F 8-5 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Worden can be reached at (571)272-4876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRYANT TANG/Examiner, Art Unit 3658
/JASON HOLLOWAY/Primary Examiner, Art Unit 3658
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