DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
An IDS has not been filed in the instant application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of US application 61/779805 filed 3/13/2013 is acknowledged.
Status of Claims
Amendments to the claims filed 3/11/2025 are acknowledged.
Claims 43-44 are new.
Claims 1-24 are cancelled.
Claims 25-44 are under examination.
Double Patenting
The rejection of claims 25-42 on the ground of nonstatutory obviousness-type double patenting over claims 1, 2, 5 and 7 of US 11,086,970 is withdrawn in view of the Terminal Disclaimer filed 3/11/2025.
The rejection of claims 25-42 on the ground of nonstatutory obviousness-type double patenting over claims 1-4, 6 and 8 of US 11,862,348 is withdrawn in view of the Terminal Disclaimer filed 3/11/2025.
Claim Rejections - 35 USC § 101
The rejection of claims 25-44 under 35 U.S.C. 101 is withdrawn in view of Applicant’s amendments filed 3/17/2026.
Claim Rejections - 35 USC § 103
The instant rejection is maintained from the previous Office Action filed 12/17/2025.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 25-44 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tuma et al. (US 2008/0319449) in view of Schumann et al. (Medical Engineering and Physics, vol. 32 (2010) pgs. 638-644) and further in view of Lang et al. (The Journal of Bone and Joint Surgery, vol. 93 (2011) pages 1296-1299).
Tuma et al. teach a method for correcting changes in a patient bone including imaging the bone joint (Abstract)(i.e. receiving a representation of the patient bone), as in claim 25, 34 and 43.
Tuma et al. teach providing a “base shape” of a bone joint to compare with the patient bone (par. 0007-0009) which can be statistical shape models or generic models (par. 0014-0015)(i.e. receiving a target bone model), as in claim 25, 34 and 43.
Tuma et al. teach selecting and overlaying the target bone shape with the patent bone (Figure 1)(i.e. registering the patient bone to the target bone), as in claims 25, 34 and 43.
Tuma et al. teach determining contour deviations of the bone joint by ascertaining contour distances between the base shape and the shape of the joint bone (par. 0008); Tuma et al. teach comparison with typical joint bone shapes (par. 0006) and standard shapes (par. 0024); Tuma et al. ascertaining contour deviations volumetrically (i.e. determining a morphological deviation) and detecting part of the bone that is to be removed; the volume can be output separately or in relation to the bone as an image in a computer assisted planning system (par. 0011 and Figure 1); Tuma et al teach determining the anomalies that should be removed (par. 0042)(i.e. based on the representation of the patient bone and the target bone model, determining a region of the patient bone that comprises a morphological deviation based on the level of disconformity between the patient and target bone model), as in claim 25, 34 and 43.
Tuma et al. teach inscribing a base shape (i.e. generic bone model) into the head of the femoral neck bone (par. 0014 and Figure 1); Tuma et al. also teach creating a new shape that has a natural bone shape by overlaying the base shape and bone model (par. 0024); the modified bone model with the natural shape would read on a “desired postoperative shape” (i.e. modifying the generic bone model to generate a target bone model having a desired postoperative shape), as in claim 43.
Tuma et al. teach a data set representing a patient bone (Abstract) as taken from a CT scan (par. 0047) or x-ray (par. 0011)(i.e. medical image), as in claim 26 and 35.
Tuma et al. teach the target bone is a shape-based model (Figure 1), statistical shape model and volumetric model (par. 0037), as in claim 27 and 36.
Tuma et al. teach a data set representing a patient bone (Abstract) as taken from a CT scan (par. 0047) or x-ray (par. 0011)(i.e. medical image), as in claims 28 and 37.
Tuma et al. teach displaying visual indicia indicating the volume to be removed on the patient bone (Figure 1 and par. 0011), as in claim 30 and 39.
Tuma et al. teach standardized models or generic models (par. 0014-0015)(i.e. a desired postoperative shape or appearance), as in claim 31 and 40.
Tuma et al. teach reshaping a femoral neck bone (par. 0039)(i.e. patient bone comprises a hip bone) and reshaping the socket part of the hip’s joint ball (i.e. acetabular rim)(Figure 1), as in claims 33 and 42.
Tuma et al. teach determining the depth and rate of the abnormality and interference caused by the abnormality (par. 0043-0044); Tuma et al. teach using a and b angles as a minimal limit for defining the volume to be removed (par. 0037)(i.e. which suggests determining a level of disconformity violates a threshold), as in claim 44.
Tuma et al. do not specifically teach a target bone model that is generated from bones corresponding to the patient bone from a group of subjects having normal bone anatomy, as in claims 25, 34 and 43.
Tuma et al. do not teach in response to the disconformity, guiding by the computer system a surgical tool to alter the morphological deviation as in claims 25, 34 and 44.
Tuma et al. do not specifically teach that the group of subjects from which the target bone is generated have at least common age, gender, ethnicity, body size or other common physical or demographic features, as in claims 29 and 38.
Tuma et al. do not specifically teach guiding a robotic surgical cutting instrument to alter the determined region comprising a morphological deviation and that the surgical tool comprises a robotic surgical tool, as in claims 25, 32 and 41.
Schumann et al. teach construction of a statistical shape model of a femur from seventeen bones (Abstract, par. 1) including normal bones (Abstract, par. 2). Schumann et al. teach a training population from seventeen cadaver bones that serve as ground truth surface models (page 642, col. 1, par. 1) used to construct the statistical shape model (page 642, col. 2, par. 5) and considered as the “normal group” (page 642, col. 2, par. 6). Schumann et al. teach that their method can construct a normal bone (page 644, col. 1, last paragraph), as in claims 25, 34 and 43.
Schumann et al. teach that the femur from the seventeen cadavers (Abstract), using datasets from all female patients (page 638, col. 2, par. 1), and healthy patients (page 639, col. 1, par. 1)(i.e. having a common sex or physical feature), as in claims 29 and 38.
Lang et al. teach computer assisted surgery in combination with surgeon guided as well and autonomous robotic systems for orthopedic surgery (Abstract); Lang et al. teach a robotic arm that resects the bone while the surgeon views a 3D model of the bone (page 1296, col. 2, lines 1-10 from bottom)(i.e. guiding by a computer system a surgical tool to alter the morphological deviation corresponding to the bone model), as in claims 25, 32, 34, and 41.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the generic, statistical bone model of Tuma et al. with the statistical shape model created from individuals with a normal bone, as taught by Schumann et al. Modifying the teachings of Tuma et al. with the statistical shape model generated for a normal bone as taught by Schumann et al. is merely a simple substitution of one known, equivalent element for another to obtain a predictable result, as set forth in KSR. The result is predictable because the statistical shape bone model of Schumann et al. would serve the same purpose and function as the base generic or statistical shape model implemented by Tuma et al., i.e. as the reference for altering a deviation in a patient bone. Using statistical shape models as references in bone surgery are well known to those of ordinary skill at the time of filing of the instant application. Schumann et al. also teach the need for statistical shapes in surgery (page 638, col. 1-2 and page 644, col. 1, par. 2). One of skill in the art would have had a reasonable expectation of success combing Tuma et al and Schumann et al. because both teach surgical planning with statistical shape bone models.
It would have been further obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Tuma et al. and Schumann et al. for computer assisted surgery using bone models with the teachings of Lang et al. where the bone deviation is operated upon with a computer system that guides a robot. Lang et al. provide motivation by teaching that robot assisted surgery can improve surgical outcomes (Abstract, par. 3). One of skill in the art would have had a reasonable expectation of success at combing Tuma et al., Schumann et al. and Lang et al. because all teach computer-assisted surgical planning with bone models.
Response to Arguments
Applicant's arguments filed 3/17/2026 have been fully considered but they are not persuasive.
Applicants argue (Remarks, page 8-9) that the prior art of Tuma, Shuman and Lang do not teach “guiding, by the computer system, a robotic surgical cutting instrument to alter the determined region comprising the morphological deviation to cause the patient bone to correspond to the target bone model.” Applicants argue (Remarks, page 9,) that Lang teaches automatically stopping the burr if the surgeon goes outside the predetermined zone of resection, and that the robotic art only serves to limit the force-controlled tip of the rotating burr so that it resects only within the confines of the predefined cutting zone.
In response, under Broadest Reasonable Interpretation (BRI) of the claim, the teaching of Lang reads on the limitation claimed. The instant claims only require “guiding, by the computer system, robotic surgical cutting instrument to alter the determined region comprising the morphological deviation…” The limitation does not recite the mechanism or the extent to which the robotic arm is guided. The teaching of Lang et al. for a robotic arm that limits the force controlled tip thereby preventing it from cutting outside a pre-defined zone reads on “guiding” a robotic surgical cutting instrument.” Furthermore, Lang teaches a pre-defined cutting zone which reads on a “determined region” as claimed. It would therefore be obvious to combine the teachings of Tuma and Shuman which make obvious a morphological deviation to be cut based on a registered normal target bone model, with the teachings of Lang for a predetermined region that is cut with a robotic arm that guides the burr by forcing it to stay within the predetermined region (i.e. such as between the periphery of a target bone region and the morphological deviation to be cut off).
Furthermore, the instant specification only provides broad disclosure for generating a surgical plan to be used within a robotic surgical cutting instrument (par. 0008), guiding a surgical tool with medical robotics (par. 0020, 0069). The instant specification does not provide specific disclosure of how the determined region of morphological deviation is used by the robotic system. The instant specification also does not disclose or describe specific components of the robotic system and how they might work to “cause the patient bone to correspond to the target bone model.”
Additional Noted Art
Ianotti et al. US 2012/0022657
Williams, Tomos G., et al. IEEE transactions on medical imaging 29.8 (2010): 1541-1559.
Barratt, Dean C., et al. Medical image analysis 12.3 (2008): 358-374.
Fleute, Markus, and Stephane Lavallee. International Conference on Medical Image Computing and Computer-Assisted Intervention. Berlin, Heidelberg: Springer Berlin Heidelberg, 1998.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Skibinsky whose telephone number is (571) 272-4373. The examiner can normally be reached on 12 pm - 8:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on (571) 272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anna Skibinsky/
Primary Examiner, AU 1635
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