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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 29, 2025 has been entered.
Response to Arguments
Applicant’s remarks concerning the previous § 103 rejections have been fully considered but are not persuasive. Applicant argues that the Pavlovskaia reference does not teach or suggest bone positioning to match a biomechanical parameter with a user input target value. To support this, Applicant argues that Pavlovskaia is limited to the system itself automatically calculating the historical anatomical baseline (i.e. desired state, or “restored bone model” to use Pavlovskaia’s terminology), rather than a “user-defined quantitative target.” The Examiner respectfully disagrees. As explained in the previous rejections, Pavlovskaia teaches that the restored bone model (i.e. having the bones moved into the desired position) can be achieved manually (either in addition to, or instead of, the automatic adjustments). For instance, in Para. 241 (cited in the previous action for this limitation), Pavlovskaia teaches that a user can manually create the restored bone model by manually manipulating the bone portion positions to desired positions, which results in computer generated 3D bone models that match the user’s input target positioning. In other words, the user inputs a “target value” (in this case, the target or desired position of the bones relative to each other, which is a biomechanical parameter) and the bone models are moved such that the bone positions match that target value. As such, the previous grounds of rejection are maintained.
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.
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.
Claims 1-4 and 7-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190239926 A1 to Pavlovskaia et al. (hereinafter “Pavlovskaia”) [cited in Applicant’s IDS] in view of US 2014/0303990 A1 to Schoenefeld (hereinafter “Schoenefeld”) in view of US 2018/0140309 A1 to Fouts et al. (hereinafter “Fouts”).
Regarding Claims 1, 8, 11-12, Pavlovskaia teaches a computer implemented method for planning an orthopedic procedure (see e.g. “computer-implemented method of preoperatively planning a surgical procedure on a knee of a patient” in the abstract), comprising:
retrieving medical imaging data comprising a portion of a first bone and a portion of a second bone, wherein the portion of the first bone and the portion of the second bone are unsegmented (see e.g. “the 2D images 16 of the patient's joint 14 are generated via the imaging system 8” in Para. 421; as noted in that same paragraph, the segmentation of individual structures such as bones (e.g. the tibia and femur) occurs after collection of the image data, i.e. the image data is originally “unsegmented”);
identifying within the medical imaging data a plurality of anatomical landmarks including at least a first anatomical landmark associated with the first bone and at least a second anatomical landmark associated with the second bone (see e.g. discussion of segmentation using landmarks beginning in Para. 419; as noted in e.g. Paras. 276, 283, 544 multiple bones may be segmented, for example the tibia and femur; also see Paras. 452 and 460-461);
indicating the plurality of anatomical landmarks in the medical imaging data with a plurality of indicators, wherein at least one of the plurality of indicators comprises a position of the bone (see e.g. landmark indicators 777 in e.g. FIGS. 35A-H);
segmenting the portion of the first bone and the portion of the second bone, such that said portion of the first bone is moveable relative said portion of the second bone (see e.g. discussion of segmentation using landmarks beginning in Para. 419; as noted in e.g. Paras. 276, 283, 544 multiple bones may be segmented, for example the tibia and femur);
moving said portion of the first bone relative to said portion of the second bone to define a planned surgical outcome by altering a biomechanical parameter relative to said first and second bone, wherein the planned surgical outcome is defined by moving said bone portions until the biomechanical parameter matches a user input target value (see e.g. block 115 in FIG. 1C and Section III (beginning at Para. 546) which generally discusses how the model derived from segmented image data is modified to arrive at a desired result (e.g. a healthy, pre-deteriorated state of a patient’s knee or other joint) after implantation. Specifically, the “restored bone model” referenced in e.g. Paras. 547-548, 552, etc. represents the movement(s) of the bones into the desired position from the original position in the “bone model” which represents the current degenerated state. Additionally, see e.g. Paras. 241, 244, 253, 705 and 712 describing manual adjustments to the models, either in addition to or instead of the automatic adjustments);
selecting at least one of a first implant component and a second implant component from among a plurality of implant components in a database, wherein the selection is based on information obtained from said first anatomical landmark and said second anatomical landmark (see e.g. the discussion of femoral implant selection in Paras. 810-812; as discussed in e.g. Para. 811, multiple candidate implants are stored in a database and are chosen based on the results of the analysis of the segmented data discussed earlier; also see e.g. Paras. 864-870 discussing the similar process for choosing a tibia implant; see e.g. Paras. 241, 244, 253, 705 and 712 describing manual adjustments either in addition to or instead of the automatic adjustments); and
fitting at least one of said first implant component and said second implant component in a space at least partially defined by said first anatomical landmark and said second anatomical landmark (see e.g. Para. 550 discussing how the procedure could be a total knee replacement, which includes placing femoral and tibial implants in the knee region which is a space at least partially defined by the landmarks associated with the lower femur and upper tibia; as noted above in Paras. 810-812 and 864-870, both femoral and tibia implants may be selected and fit into the appropriate space; see e.g. Paras. 241, 244, 253, 705 and 712 describing manual adjustments either in addition to or instead of the automatic adjustments).
Pavlovskaia fails to teach that the anatomical landmarks are [automatically/automatedly] identified within the medical imaging data using a computer-implemented analytical model. Another similar reference, Schoenefeld, teaches this limitation in roughly the same context (see e.g. Para. 7: “A patient specific three-dimensional model of the patient's bone joint can be generated automatically, at the server, and can include identification of anatomical landmarks based at least on the preoperative image data and the database three-dimensional model data” and Para. 9: “Generating the patient specific three-dimensional model of the patient's bone joint can include automatically identifying anatomical landmarks on the generated patient specific three-dimensional model based at least on the preoperative image data and the defined anatomical landmarks in the database three-dimensional bone model data.”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Pavlovskaia to include [automatically/automatedly] identifying the landmarks within the medical imaging data using a computer-implemented analytical model, as taught by Schoenefeld, to provide the well understood benefits of automation such as speed, convenience and accuracy.
Concerning the limitation of at least one of the landmark indicators comprising a dimension of the bone, the Examiner notes that when analyzed in relation to other data, e.g. other landmarks, each landmark does provide information as to the dimension of the bone (e.g. see Paras. 468, 506-508 describing measuring distances from landmarks). However, in the interest of being thorough, it is acknowledged that Pavlovskaia fails to specifically teach that a single landmark indicator comprises a dimension of the bone (i.e. by itself without comparison to other landmarks or other data). Another reference, Fouts, teaches a related invention including bone imaging and image annotation prior to or during surgery, including the step of placing a re-sizeable circle (circle 5; see e.g. FIGS. 36-38) over the femoral head to approximate the size (e.g. diameter) of the head (see Paras. 36, 175-176 and 184-185; note that this process can be manually done as described in Para. 36, or also see e.g. Paras. 156-163 describing how this might be done automatically instead of manually from the surgeon). The diameter of the circle (5) approximates the diameter of the head, and the centerpoint (185) of the circle may be considered to represent the center of rotation of the head. It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Pavlovskaia to incorporate the placement of a circle landmark over the head of the femur (thereby indicating both the position and dimensions of the head of the femur, including diameter and center of rotation) since it would increase the total amount of useful information provided in the image, and would be useful in procedures involving the hip joint (note e.g. Para. 283, 292, 307 etc. of Pavlovskaia indicating that various joints including the hip can be imaged as part of the invention – search for “hip” to see other indications throughout the reference).
Regarding Claims 2-3 and 13-14, see e.g. block 115 in FIG. 1C and Section III (beginning at Para. 546) which generally discusses how the model derived from segmented image data is modified to arrive at a desired result (e.g. a healthy, pre-deteriorated state of a patient’s knee or other joint) after implantation. Specifically, the “restored bone model” referenced in e.g. Paras. 547-548, 552, etc. represents the movement(s) of the bones into the desired position from the original position in the “bone model” which represents the current degenerated state.
Additionally, see e.g. Paras. 241, 244, 253, 705 and 712 describing a manually adjustments to the models, either in addition to or instead of the automatic adjustments.
Further concerning claim 13, the user must eventually move on after making manual identifications of the landmarks. For instance, looking at FIG. 33, in which the landmarks are set at block 251, by either moving on to block 252 (or, alternatively, by selecting “Yes” and moving to “End”), this action effectively serves as a user confirmation of the landmark choices/selections made previously.
Regarding Claims 4, 9-10 and 15, again see e.g. Paras. 810-812 which discusses selection of the implant. As noted in e.g. Para. 688, “the implant planning may take place utilizing the image data (e.g., 2D image slices) of the bone models representative of the patient's bones in a pre-deteriorated state (described in Section III),” i.e. after segmentation and after the first and second bones have been moved/modified relative to each other. It is noted that not only is the position of each individual landmark of course known, but also those landmarks represent dimension(s) when compared to other landmarks or other locations (e.g. see Paras. 468, 506-508 describing measuring distances from landmarks).
Regarding Claim 7, see e.g. discussion of segmentation using landmarks beginning in Para. 419, in which three (or many more) landmarks (e.g. 777) are contemplated; as noted in e.g. Paras. 276, 283, 544 multiple bones may be segmented, for example the tibia and femur.
Regarding Claims 16, 19 and 22, the user must eventually move on after making manual identifications of the landmarks. For instance, looking at FIG. 33, in which the landmarks are set at block 251, by either moving on to block 252 (or, alternatively, by selecting “Yes” and moving to “End”), this action effectively serves as a user confirmation of the landmark choices/selections made previously.
Regarding Claim 17, as noted in Para. 429 (and elsewhere, such as Paras. 47-48, 267; search for “automatic segmentation”), Pavlovskaia offers an option for an auto-segmentation feature which can be independent of user-identified landmarks.
Regarding Claim 18, see the rejections above for claims 3, 12, 13, 16-17, which collectively include all of the limitations of claim 18.
Regarding Claim 20, see the rejection of claim 1 above; see e.g. discussion of segmentation using landmarks beginning in Para. 419; as noted in e.g. Paras. 276, 283, 544 multiple bones may be segmented, for example the tibia and femur.
Regarding Claims 21 and 23, see e.g. Para. 285 of Pavlovskaia (the user can modify the initial automatedly suggested segmentation).
Claims 13, 16, 18-19 and 22 are also rejected under 35 U.S.C. 103 as being unpatentable over Pavlovskaia in view of Schoenefeld in view of Fouts as applied to claim 12 above, and further in view of US 2016/0022286 A1 to Borries et al. (hereinafter “Borries”).
Regarding Claims 13, 16, 19 and 22, see e.g. block 115 in FIG. 1C and Section III (beginning at Para. 546) which generally discusses how the model derived from segmented image data is modified to arrive at a desired result (e.g. a healthy, pre-deteriorated state of a patient’s knee or other joint) after implantation. Specifically, the “restored bone model” referenced in e.g. Paras. 547-548, 552, etc. represents the movement(s) of the bones into the desired position from the original position in the “bone model” which represents the current degenerated state.
Additionally, see e.g. Paras. 241, 244, 253, 705 and 712 describing a manually adjustments to the models, either in addition to or instead of the automatic adjustments.
Pavlovskaia as modified above arguably fails to specifically teach allowing or requiring the user to confirm identification of the anatomical landmarks identified by the model. Another reference, Borries, teaches this limitation in a similar context (see e.g. Para. 39: “GUI 500 can automatically generate and visually depict radiographic image 502 of the patient's femur including stem tip landmark 318. GUI 500 can then prompt the surgeon or other user to confirm that the location of landmark 318 is correct or to move the landmark and then confirm the tip of the stem has been properly located.”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Pavlovskaia to allow/require confirmation from the surgeon/user of the proper landmark location because it would predictably and advantageously help reduce or prevent any errors with the automatic landmark detection.
Regarding Claim 18, see the rejections above for claims 3, 12, 13, 16 and 17, which collectively include all of the limitations of claim 18; under at least one interpretation, these teachings fail to specifically teach allowing or requiring the user to confirm identification of the anatomical landmarks identified by the model. Another reference, Borries, teaches this limitation in a similar context (see e.g. Para. 39: “GUI 500 can automatically generate and visually depict radiographic image 502 of the patient's femur including stem tip landmark 318. GUI 500 can then prompt the surgeon or other user to confirm that the location of landmark 318 is correct or to move the landmark and then confirm the tip of the stem has been properly located.”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Pavlovskaia to allow/require confirmation from the surgeon/user of the proper landmark location because it would predictably and advantageously help reduce or prevent any errors with the automatic landmark detection.
Claims 17, 20-21 and 23 are also rejected under 35 U.S.C. 103 as being unpatentable over Pavlovskaia in view of Schoenefeld in view of Fouts as applied to claims 1 and 18 above, and further in view of US 2014/0093153 A1 to Sofka et al. [cited in Applicant’s IDS]
Regarding Claims 17 and 20, Pavlovskaia as modified above is considered to render these claims obvious as discussed above. As further evidence, attention is directed to Sofka which teaches an automatic segmentation process using a model and which can be independent of any identified landmarks (see e.g. automatic segmentation step 504 which occurs prior to landmark identification in 506). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Pavlovskaia to include an automated segmentation process independent of landmarks because Sofka demonstrates that this technique was known in almost the same context and thus the modification would merely require adapting a known technique from one reference into another to yield only predictable results.
Regarding Claims 21 and 23, see e.g. Para. 285 of Pavlovskaia (the user can modify the initial automatedly suggested segmentation).
Alternatively, see e.g. step 512 of Sofka described in e.g. Paras. 41-45. It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Pavlovskaia to allow/require the user to correct and/or confirm the suggested segmentation, as taught in Sofka, because doing so would advantageously help improve the accuracy of the segmentation based on the expertise of the surgeon/operator.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792