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 .
This Office Action is in response to claims filed on 08/12/2025
Claims 1-15 are pending.
Claims 1, 3, 10, 12 and 15
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/12/2025 is being considered by the examiner.
Claim Objections
Applicant’s arguments, see page 6, filed 08/12/2025, with respect to claims 1, 3, 10 and 15 have been fully considered and are persuasive. The Claims objection of claims 1, 3, 10 and 15 has been withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see page 6, filed 08/12/2025, with respect to claims 3 and 4 have been fully considered and are persuasive. The Claims rejection of claims 3 and 4 has been withdrawn.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 08/12/2025 have been fully considered but they are not persuasive. The claims rejection of claims 1-15 are maintained.
Claim Rejections - 35 USC § 102
Applicant argues on page 9, “there is no disclosure in Mako that the images shown in these figures are segmented to obtain points belonging to the planar cutting surface and points belonging to the target bone”. Mako discloses checkpoint verification, by placing a blunt probe on the target bone and on the planar cutting surface. Mako differentiates the target bone and the cutting tool, thus segmenting each as an individual that has to be checkpoint verified. Furthermore, applicant argues, “additionally that a spatial orientation and position of an osteotomy plane is obtained by fitting a plane to the segmented points obtained from these images”, applicant agues on features not claimed “obtained from these images”, Mako discloses the spatial orientation and position of an osteotomy plane is obtained by fitting a plane to the segmented cutting tool, as seen on Mako page 48, on the cutting mode, where a blue color plane represents the cutting tool.
Applicant's arguments filed 08/12/2025 have been fully considered but they are not persuasive. The claims rejection of claims 1-4, 7-12 and 15 are maintained.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 08/12/2025 have been fully considered but they are not persuasive. The claims rejection of claims 5, 6 13 and 14 are maintained.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
To determine if a claim is directed to patent ineligible subject matter, the Court has guided the Office to apply the Alice/Mayo test, which requires:
1. Determining if the claim falls within a statutory category;
2A. Determining if the claim is directed to a patent ineligible judicial exception consisting of a law of nature, a natural phenomenon, or abstract idea; and
Step 2A is a two-prong inquiry. MPEP 2106.04(II)(A). Under the first prong, examiners evaluate whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. Abstract ideas include mathematical concepts, certain methods of organizing human activity, and mental processes. MPEP 2106.04(a)(2). The second prong is an inquiry into whether the claim integrates a judicial exception into a practical application. MPEP 2106.04(d).
2B. If the claim is directed to a judicial exception, determining if the claim recites limitations or elements that amount to significantly more than the judicial exception. (See MPEP 2106).
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite a mental process and a mathematical calculation; see MPEP 2106.04(a)(2)(I) and MPEP 2106.04(a)(2)(III).
Step 1:
Claims 1-8 are directed to the statutory category of processes.
Claim 1 Step 2A prong 1:
For the sake of identifying the abstract ideas, a copy of the claim is provided below. Abstract ideas are bolded.
A computer-implemented method for intra-operatively predicting an outcome of a planar cut performed with a planar surgical tool on a target bone of a subject, wherein said planar surgical tool comprises a planar cutting surface, said method comprising:
receiving at least one 3D image previously acquired from at least one 3D imaging sensor; said 3D image being a 3D point cloud comprising at least one portion of the target bone and at least one portion of planar cutting surface of the planar surgical tool;
segmenting the 3D image to obtain points of the 3D image belonging to the planar cutting surface of the surgical tool and points of the 3D image belonging to the target bone;
obtaining a spatial orientation and position of an osteotomy plane by fitting a plane to the segmented points belonging to the planar cutting surface of the planar surgical tool;
overlapping the osteotomy plane to the segmented points belonging to the target bone and selecting the points belonging to the portion of target bone intended to be removed with the planar surgical tool; and
outputting the points belonging to the portion of target bone intended to be removed with the surgical tool (Pr).
The limitations “predicting an outcome of a planar cut performed with a planar surgical tool on a target bone of a subject”, “segmenting the 3D image to obtain points of the 3D image belonging to the planar cutting surface of the surgical tool and points of the 3D image belonging to the target bone”, “fitting a plane to the segmented points belonging to the planar cutting surface of the planar surgical tool”, “overlapping the osteotomy plane to the segmented points belonging to the target bone” and “selecting the points belonging to the portion of target bone intended to be removed with the planar surgical tool” are an abstract ideas because it is directed to a mathematical model. The limitation, as drafted and under broadest reasonable interpretation, “can be performed using mathematical equations” MPEP 2106.04(a)(2)(I). Also, the limitation, as drafted and under broadest reasonable interpretation, “can be performed in the human mind or by a human using a pen and paper”. MPEP 2106.04(a)(2)(III). For example, a human could, mentally or on paper, observe, evaluate or analyze to make the determination of a model and its output.
Claim 1 Step 2A prong 2:
Under step 2A prong two, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present general field of use or insignificant extra-solution activity. In particular, the claim recites the additional limitations:
“A computer-implemented method for and wherein said planar surgical tool comprises a planar cutting surface” (general field of use – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
“receiving at least one 3D image previously acquired from at least one 3D imaging sensor; said 3D image being a 3D point cloud comprising at least one portion of the target bone and at least one portion of planar cutting surface of the planar surgical tool” (general field of use and data gathering – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
“obtaining a spatial orientation and position of an osteotomy plane” (general field of use and data gathering – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
“outputting the points belonging to the portion of target bone intended to be removed with the surgical tool (Pr)” (general field of use and data displaying – see MPEP 2106.04(d) referencing MPEP 2106.05(h))
Claim 1 Step 2B:
The Examiner must consider whether each claim limitation individually or as an ordered combination amount to significantly more than the abstract idea. This analysis includes determining whether an inventive concept is furnished by an element or a combination of elements that are beyond the judicial exception. For limitations that were categorized as “apply it” or generally linking the use of the abstract idea to a particular technological environment or field of use, the analysis is the same. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations considered directed towards field of use or insignificant extra-solution activity. See MPEP 2106.04(d) referencing MPEP 2106.05(h) and MPEP2106.05(g).
The insignificant extra-solution receiving data is further Well-Understood, Routine and Conventional (WURC), see MPEP § 2106.05(d)(II) “The courts have recognized the following computer functions as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. (ii) The prior art relied upon below within the 35 USC 102/103 rejection section shows that the computer functions are well-understood, routine and conventional functions.
Considering the claim limitations as an ordered combination, claim 1 does not include significantly more than the abstract idea.
Claim 2 further recites: “further comprising generating a simulated 3D model of the removed bone portion using the points belonging to the portion of target bone intended to be removed with the surgical tool” These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. The additional feature(s) are considered to further clarify the outcomes that are being determined (mental observation of outputting) under step 2A prong 1 of the abstract idea analysis. MPEP 2106.04(a)(2)(III). Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 3 recites “further comprising: receiving a 3D model of the bone and a preoperative planning comprising equations of planned cutting planes in a reference frame of the 3D model of the bone, obtaining a planned 3D model of the removed bone portion by applying the equations of the planned cutting planes to the 3D model of the bone, comparing the simulated 3D model and said planned 3D model of the removed bone portion and outputting the result of said comparison” These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. The additional feature(s) are considered to further clarify the 3D models that are being compared (mental observation of determining the difference) under step 2A prong 1 of the abstract idea analysis, or alternatively, the limitation is considered to further define the mathematical formula. MPEP 2106.04(a)(2)(I) and MPEP 2106.04(a)(2)(III). Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 4 recites “wherein the result of the comparison is a 3D shape similarity measure or a matching error” This limitation is considered to be a field of use limitation, because it defines the type of data that is being considered. see MPEP 2106.05(d) referencing MPEP 2106.05(h). These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 5 recites “further comprising calculating principal components of the simulated 3D model, defining from the principal components a bounding box of the removed bone portion and estimating from the bounding box a thickness of the removed bone portion” The additional feature(s) are considered to further clarify the models that are being determined (mental observation of estimating) under step 2A prong 1 of the abstract idea analysis, or alternatively, the limitation is considered to further define the mathematical formula. MPEP 2106.04(a)(2)(I) and MPEP 2106.04(a)(2)(III).
These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 6 recites “further comprising comparing said estimated thickness of the removed bone portion to a planned thickness of the removed bone portion and outputting an alert whenever a deviation from the planned thickness is detected” These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. The additional feature(s) are considered to further clarify estimating thickness (mental observation of estimating) under step 2A prong 1 of the abstract idea analysis, MPEP 2106.04(a)(2)(III). Therefore, the claim is considered to be ineligible under 35 USC 101.
Claim 7 recites “wherein the surgical tool comprises a fiducial marker to help obtaining the spatial orientation and position of the osteotomy plane.” This limitation is considered to be a field of use limitation, because it defines the objects that are being considered. see MPEP 2106.05(d) referencing MPEP 2106.05(h). These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. Therefore, the claim is considered to be ineligible
Claim 8 recites “wherein the target bone is a femur or a tibia” This limitation is considered to be a field of use limitation, because it defines the bones that are being considered. see MPEP 2106.05(d) referencing MPEP 2106.05(h). These feature(s) have been considered in combination with the feature required by the claim(s) from which it depends. Therefore, the claim is considered to be ineligible
Claim 9 has substantially similar limitations as stated in claim 1; therefore, it is being rejected under 35 USC 101 under the same rationale.
Regarding claims 10-15 are rejected under 35 U.S.C. 101
Step 1:
Claims 10-15 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to non-statutory subject matter. During examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, 367 F.3d 1359, 1369, 70 U.S.P.Q.2d 1827, 1834 (Fed. Cir. 2004). Independent claim 16 recites a “computer-readable medium,” which is not comprehensively defined by the specification. The broadest reasonable interpretation of a claim drawn to a computer readable medium covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. Transitory propagating signals are non-statutory subject matter. In re Nuijten, 500 F.3d 1346, 1356-57, 84 U.S.P.Q.2d 1495, 1502 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter). See also Subject Matter Eligibility of Computer Readable Media, 1351 Off. Gaz. Pat. Office 212 (Feb. 23, 2010).
However, for purposes of compact prosecution, the claims are being further considered under the abstract idea two step analysis.
Claim 10 Step 2A prong 1:
The claim language is substantially similar as claim 1, except for the following claim elements/limitations: A system for
The claim does not include any additional abstract ideas from claim 1
Claim 10 Step 2A prong 2:
Under step 2A prong two, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present general field of use or insignificant extra-solution activity. In particular, the claim recites the additional limitations:
“A system for” (general field of use – see MPEP 2106.04(d) referencing MPEP 2106.05(h)) (Mere Instructions to Apply an Exception, MPEP § 2106.05(f))
Claim 10 Step 2B:
The additional limitations found in claim 10, this additional elements are recited at a high level of generality (computer readable medium, processor, and system) and would function in its ordinary capacity for measuring a temperature, this additional element does not integrate the judicial exception into a practical application and does not amount to significantly more. These additional elements do not integrate the judicial exception into a practical application and do not amount to significantly more. Step 2A Prong I and Step 2B.
Considering the claim limitations as an ordered combination, claim 10 does not include significantly more than the abstract idea.
Claim 11 has substantially similar limitations as stated in claims 2; therefore, it is being rejected under 35 USC 101 under the same rationale.
Claim 12 has substantially similar limitations as stated in claim 3; therefore, it is being rejected under 35 USC 101 under the same rationale.
Claim 13 has substantially similar limitations as stated in claim 5; therefore, it is being rejected under 35 USC 101 under the same rationale.
Claim 14 has substantially similar limitations as stated in claim 6; therefore, it is being rejected under 35 USC 101 under the same rationale.
Claim 15 has substantially similar limitations as stated in claim 4; therefore, it is being rejected under 35 USC 101 under the same rationale.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4, 7-12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mako TKA, NPL “MAKO TKA Surgical Guide”, Published: 2016, (hereafter Mako).
Regarding claim 1. Mako teaches a computer-implemented method for intra-operatively predicting an outcome of a planar cut performed with a planar surgical tool on a target bone of a subject (Page 31, Implant planning)(Page 49, figure 34 and 35), wherein said planar surgical tool comprises a planar cutting surface (Page 47, figure 30 and 31, saw attachment is a planer cutting surface)(Page 49, figure 34 and 35), said method comprising:
receiving at least one 3D image previously acquired from at least one 3D imaging sensor (Page 5, pre operative implant planning using a patient specific CT-based bone model, Computer tomography (CT), thus the 3D image was acquired from at least CT imaging sensor);
said 3D image being a 3D point cloud comprising at least one portion of the target bone and at least one portion of planar cutting surface of the planar surgical tool (Page 47, figure 30 and 31, 3D image (having points on 3D space) with the bone and saw having a planer cutting surface);
segmenting the 3D image to obtain points of the 3D image belonging to the planar cutting surface of the surgical tool and points of the 3D image belonging to the target bone (Page 48, figure 33, 3D image that contains the green volume (target bone) and the cutting surface (blue))(Page 32, figure 19, implant planning, segments the white volume bone (containing points of the 3D image) and the green volume bone (containing points of the Target bone) to be removed with distinct linear plane cuts (interface between the white volume and green volume));
obtaining a spatial orientation and position of an osteotomy plane by fitting a plane to the segmented points belonging to the planar cutting surface of the planar surgical tool (Page 48, figure 33, 3D image that contains segments of the green volume (target bone) and the cutting surface (blue)) (Page 45, 6, align the saw blade to the cutting plane (osteotomy plane))(Page 47, figure 30 and 31, saw orientation, to accommodate the required approach angle);
overlapping the osteotomy plane to the segmented points belonging to the target bone (Page 32, figure 19, implant planning, overlap the green volume bone (Target bone) to be removed with distinct linear plane cuts (interface between the white volume and green volume), visualize the after cut, the bone is separated into segments of different colors) and selecting the points belonging to the portion of target bone intended to be removed with the planar surgical tool (Page 52, figure 37, the green volume overlaps the white volume and has a different color for removal); and
outputting the points belonging to the portion of target bone intended to be removed with the surgical tool (Pr) (Page 52, figure 37, displaying (outputting) the 3D green volume containing points to be removed) (Page 49, figure 34 and 35, Displays the saw planer cutting tool removes the green material).
Regarding claim 2. Mako teaches the method according to claim 1, further comprising generating a simulated 3D model of the removed bone portion using the points belonging to the portion of target bone intended to be removed with the surgical tool (Page 52, figure 37, the green volume of bone to be resected, showing points belonging to the portion of the target bone that is intended to be removed).
Regarding claim 3. Mako teaches the method according to claim 2, further comprising:
receiving a 3D model of the bone and a preoperative planning comprising equations of planned cutting planes in a reference frame of the 3D model of the bone (Page 5, pre operative implant planning using a patient specific CT-based bone model)(Page 9, table 1, table 2, table 3, provide the recommended implant planning guidelines )(Page 12, table 1)(Page 15, table 2)(Page 16, table 3),
obtaining a planned 3D model of the removed bone portion by applying the equations of the planned cutting planes to the 3D model of the bone (Page 8, sec B, calculated based on a software algorithm, the calculating is performed by the software algorithm thus applying equations)(Page 40, figure 27 and 28,resection view, virtual resection ),
comparing the simulated 3D model and said planned 3D model of the removed bone portion (Page 46, confirm accuracy of bone resection, establish accurate bone resection depth, examiner notes, confirming resection depth thus comparing the expected planned 3D model with the actual 3D measurement analyzing the 3D shape by measuring the result) and
outputting the result of said comparison (Page 53, resection depth error and two angular errors are displayed).
Regarding claim 4. Mako teaches the method according to claim 3, wherein the result of the comparison is a 3D shape similarity measure or a matching error (Page 53, resection depth to better match the desired contact point to determine the difference).
Regarding claim 7. Mako teaches the method according to claim 1, wherein the surgical tool comprises a fiducial marker to help obtaining the spatial orientation and position of the osteotomy plane (Page 6, VIZADISC, reflective markers that attach, track their location)(Page 19, 6, to all tracking arrays and probes)(Page 18, direct line of sight is required for all tracking arrays, paced across the robotic arm).
Regarding claim 8. Mako teaches the method according to claim 1, wherein the target bone is a femur or a tibia (Page 6, TKA, cutting steps for the femur and tibia).
Regarding claim 9. Mako teaches a non-transitory computer readable medium comprising instructions which, when executed by a computer, cause the computer to carry out the steps of the method according to claim 1 (Page 22, figure 7, implant system, stryker, has a Graphical user interface that displays and computes the planning, thus a computer having computer readable media is being used to perform the surgery planning)(Claim 9 comprises the steps according to claim 1, and is rejected as was rejected claim 1).
Regarding claim 10. Mako teaches a system for intra-operatively predicting an outcome of a planar cut performed with a planar surgical tool on a target bone of a subject (Page 22, figure 7, implant system, Stryker, has a Graphical user interface that displays and computes the planning,) (Page 31, Implant planning)(Page 49, figure 34 and 35), wherein the planar surgical tool comprises a planar cutting surface (Page 47, figure 30 and 31, saw attachment is a planer cutting surface)(Page 49, figure 34 and 35), said system comprising:
at least one input adapted to receive at least one 3D image previously acquired from at least one 3D imaging sensor (Page 5, pre operative implant planning using a patient specific CT-based bone model, Computer tomography (CT), thus the 3D image was acquired from at least CT imaging sensor), said 3D image being a 3D point cloud comprising at least one portion of the target bone and at least one portion of the planar cutting surface of the surgical tool (Page 47, figure 30 and 31, 3D image (having points on 3D space) with the bone and saw having a planer cutting surface),
at least one processor (Page 22, figure 7, implant system, Stryker) configured to:
segment the 3D image to obtain points of the 3D image belonging to the planar cutting surface of the planar surgical tool and points of the 3D image belonging to the target bone (Page 48, figure 33, 3D image that contains the green volume (target bone) and the cutting surface (blue))(Page 32, figure 19, implant planning, segments the white volume bone (containing points of the 3D image) and the green volume bone (containing points of the Target bone) to be removed with distinct linear plane cuts (interface between the white volume and green volume));
obtain a spatial orientation and position of an osteotomy plane by 3D fitting the segmented points belonging to the planar cutting surface of the planar surgical tool (Page 48, figure 33, 3D image that contains segments of the green volume (target bone) and the cutting surface (blue)) (Page 45, 6, align the saw blade to the cutting plane (osteotomy plane))(Page 47, figure 30 and 31, saw orientation, to accommodate the required approach angle); and
overlap the osteotomy plane to the segmented points belonging to the target bone (Page 32, figure 19, implant planning, overlap the green volume bone (Target bone) to be removed with distinct linear plane cuts (interface between the white volume and green volume), visualize the after cut, the bone is separated into segments of different colors) and
selecting the points belonging to the portion of target bone intended to be removed with the planar surgical tool (Page 52, figure 37, the green volume overlaps the white volume and has a different color for removal, the removed portions (points) was selected and removed, while the green is intended to be removed); and
at least one output adapted to provide the points belonging to the portion of target bone intended to be removed with the surgical tool (Page 52, figure 37, displaying (providing an output) the 3D green volume containing points to be removed) (Page 49, figure 34 and 35, Displays the saw planer cutting tool removes the green material).
Regarding claim 11. Mako teaches the system according to claim 10, wherein the at least one processor is further configured to generate a simulated 3D model of the removed bone portion using the points belonging to the portion of target bone intended to be removed with the surgical tool (Page 52, figure 37, the green volume of bone to be resected, showing points belonging to the portion of the target bone that is intended to be removed, as the points selected are removed a new display is generated with the selected region being removed).
Regarding claim 12. Mako teaches the system according to claim 10, wherein the at least one processor is further configured to:
receive a 3D model of the bone and a preoperative planning comprising equations of the planned cutting planes in a reference frame of the 3D model of the bone (Page 8, sec B, calculated based on a software algorithm, the calculating is performed by the software algorithm thus applying equations) (Page 5, pre operative implant planning using a patient specific CT-based bone model)(Page 9, table 1, table 2, table 3, provide the recommended implant planning guidelines )(Page 12, table 1)(Page 15, table 2)(Page 16, table 3),
obtain a planned 3D model of the removed bone portion by applying the equations of the cutting planes to the 3D model of the bone (Page 8, sec B, calculated based on a software algorithm, the calculating is performed by the software algorithm thus applying equations)(Page 40, figure 27 and 28,resection view, virtual resection ),
compare the simulated 3D model and said planned 3D model of the removed bone portion using 3D shape analysis (Page 46, confirm accuracy of bone resection, establish accurate bone resection depth, examiner notes, confirming resection depth thus comparing the expected planned 3D model with the actual 3D measurement analyzing the 3D shape by measuring the result) and
output the result of said comparison (Page 53, resection depth error and two angular errors are displayed).
Regarding claim 15. Mako teaches the system according to claim 12, wherein
the result of the comparison between the simulated 3D model and said planned 3D model is a 3D shape similarity measure or a matching error (Page 53, resection depth to better match the desired contact point to determine the difference).
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.
Claims 5-6 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mako TKA, NPL “MAKO TKA Surgical Guide”, Published: 2016, (hereafter Mako), in views of Lukas Jud, “Combined Correction of Tibial Torsion and Tibial Tuberosity-Trochlear Groove Distance by Supratuberositary Torsional Osteotomy of the Tibia (hereafter Jud).
Regarding claim 5. Mako teaches the method according to claim 2, further comprising
calculating principal components of the simulated 3D model (Page 52, flexion 108.5, is displayed, thus calculated for the planned bone resection, white model),
defining from the principal components a bounding box of the removed bone portion (Page 52, figure 37, defines a bounding volume (green) of the removed bone portion) and
estimating from the bounding box a thickness of the removed bone portion (Page 52, green, this green region is located 0.25 mm above implant plan, thus estimating the amount of bone it needs to remove).
Mako does not teach a principal component defining a bound box and estimating a thickness from the bounding box.
Jud teaches a principal component defining a bound box and estimating a thickness from the bounding box (Jud, Jud, Page 2262, col 2, an oriented bounding box around the proximal fragment was generated per principal component analysis) (Jud, Page 2263, col 2, box was extended until the most anterior point was identified).
Both Mako and Jud are considered to be analogous arts, because both relate to 3D modeling of bones. Mako: e.g., page 7, first paragraph; Jud: e.g., page 2260 “Methods” paragraph. Mako discloses the various modeling methods; however, Mako fails to specifically disclose a principal component defining a bounding box and estimating a thickness from the bounding box. On the other hand, Jud discloses using a bounding box and estimating a thickness from the bounding box, which is beneficial, because it provides enhanced ways to predict corrections to the planned surgery. Jud: e.g., page 2261, col 1 paragraph 1. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the bounding box and thickness estimation as Jud to the method of Mako to enhance accuracy and provide predicted corrections to the method.
Regarding claim 6. Mako and Jud teach the method according to claim 5, further comprising
comparing said estimated thickness of the removed bone portion to a planned thickness of the removed bone portion (Mako, Page 53, resection depth to better match the desired contact point thus comparing the resection depth (thickness) of the resected bone) and
outputting an alert whenever a deviation from the planned thickness is detected (Mako, Page 53, resection depth error and two angular errors are displayed)(Mako, Page 52, figure 37, red, the volume of bone that appears, the resulting resection is too deep, an audio warning, or disable the saw).
Regarding claim 13. Mako teaches the system according to claim 11, wherein the at least one processor is further configured to
calculating principal components of the simulated 3D model (Page 52, flexion 108.5, is displayed, thus calculated for the planned bone resection, white model),
defining from the principal components a bounding box of the removed bone portion (Page 52, figure 37, defines a bounding volume (green) of the removed bone portion) and
estimating from the bounding box a thickness of the removed bone portion (Page 52, green, this green region is located 0.25 mm above implant plan, thus estimating the amount of bone it needs to remove).
Mako does not teach a principal component defining a bound box and estimating a thickness from the bounding box.
Jud teaches a principal component defining a bound box and estimating a thickness from the bounding box (Jud, Jud, Page 2262, col 2, an oriented bounding box around the proximal fragment was generated per principal component analysis)
Both Mako and Jud are considered to be analogous arts, because both relate to 3D modeling of bones. Mako: e.g., page 7, first paragraph; Jud: e.g., page 2260 “Methods” paragraph. Mako discloses the various modeling methods; however, Mako fails to specifically disclose a principal component defining a bounding box and estimating a thickness from the bounding box. On the other hand, Jud discloses using a bounding box and estimating a thickness from the bounding box, which is beneficial, because provides enhanced ways to predict corrections to the planned surgery. Jud: e.g., page 2261, col 1 paragraph 1. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the bounding box and thickness estimation as Jud to the method of Mako to enhance accuracy and provide predicted corrections to the method.
Regarding claim 14. Mako and Jud teach the system according to claim 13, wherein the at least one processor is further configured to
comparing said estimated thickness of the removed bone portion to a planned thickness of the removed bone portion (Mako, Page 53, resection depth to better match the desired contact point thus comparing the resection depth (thickness) of the resected bone) and
outputting an alert whenever a deviation from the planned thickness is detected (Mako, Page 53, resection depth error and two angular errors are displayed)(Mako, Page 52, figure 37, red, the volume of bone that appears, the resulting resection is too deep, an audio warning, or disable the saw).
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 ANGEL JAVIER CALLE whose telephone number is (571)272-0463. The examiner can normally be reached Monday - Friday 7:30 a.m. - 5 p.m..
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rehana Perveen can be reached at (571)-272-3676. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.C/Examiner, Art Unit 2189
/REHANA PERVEEN/Supervisory Patent Examiner, Art Unit 2189