The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Objections
Claims 5-7 is objected to because of the following informalities:
Claims 5 and 6 are objected to because they both recite “The method of claims 1…”, whereas the word “claims” should not be plural.
Claim 7 is objected to because it recites “The method of any of claims 1…”. The words “any of” should be removed and the word “claims” should not be plural.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-7 and 16-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5 and 6 are both rejected because (a) “the probe tip” and “the trackable cut plane” lack antecedent basis, as they are introduced in claim 3 and claim 2 respectively, while claim 5 depends from claim 1; and (b) “the one or more surgical tools” lacks antecedent basis because claim 1 recites “one or more surgical instruments”.
Claim 7 is rejected because “the trackable cut plane” lacks antecedent basis.
Claim 16 is rejected because “the trackable cut plane” lacks antecedent basis.
Claim 17 is rejected because “the one or more surgical tools” in lines 14-15 lacks antecedent basis and should state “the one or more surgical instruments” as is recited in line 5.
Claim 18 is rejected because “the user interface” lacks antecedent basis.
Claim 20 is rejected because the “or” which comes after a semi-colon in line 4 makes the claim unclear. It is not clear where the alternative presented by the “or” presents the plural options. For instance, it is unclear if the “dividing” and “determining” are both positively required or “respective dynamic distal points of each area for the non-planar profile for the one respective mesh” stands alone. It also could be interpreted that the “or” makes it so only one of the three is required (i.e., “dividing…”, or “determining…,” or “respective dynamic…” are all three alternatives). The claim is currently unclear based on the wording and placement of “or”.
Claim 19 is rejected based on its dependency from claim 18, thereby containing the same described issues.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moctezuma et al. (WO 2018/189725).
Moctezuma teaches a computer implemented method comprising:
receiving tracking information of an anatomic structure of a patient (see tracker 136 in Figure 27 and corresponding “virtual first patient tracker 136V”);
receiving tracking information of one or more surgical instruments (see pointer tracker 120 in Figure 27 and corresponding “virtual digitization device 106V”);
receiving at least one plurality of anatomic points identifying actual locations in one or more regions of the anatomic structure of the patient (see Figures 28-34, which illustrating receiving of a plurality of anatomic points as point cloud data in Figures 28-29 and isolated additional anatomic points in Figures 30-34);
generating a respective mesh for each of the one or more regions from the at least one plurality of anatomic points (see Figures 35-45, which illustrate additional steps of localizing planes, ultimately ending with the generation of mesh MV within Figure 45);
generating a non-planar profile for each respective mesh (see mesh MV in Figure 45, which is a volumetric profile having two planar edges connected by the non-planar cylindrical portion as seen in Figures 46A or 47); and
displaying one or more non-planar profiles via the user interface (see all previously mentioned Figures which illustrate displays of the user interface).
Allowable Subject Matter
Claims 1-4 and 8-15 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach the generation of two planar profiles from one or more respective meshes, wherein each planar profile is defined to b as lice that is parallel to one or both of an anatomic axis or an anatomic reference plane; displaying the at least two planar profiles simultaneously via a user interface”; receiving updated tracking information of the anatomic structure and the one or more surgical instruments; updating the at least two planar profiles according to the updated tracking information; and displaying the at least two updated planar profiles on a user interface”, as recited in claim 1.
Similar subject matter is present in claim 17, and would be allowable also if all pending formality issues are resolved.
US Patent Pub. No. 2023/0233259 to Young et al. teaches the use of augmented reality devices and pointers in generating intra-operative plans and providing guidance for knee surgery. A pointer may indicate one or more anatomical points. An augmented reality device may detect positions of knee anatomical features based on a position of the pointer and positions of fiducials associated with a marker affixed to body part proximate to a knee, such as a femur or a tibia. Figures 10A-T illustrate a surgeon acquiring a point cloud and/or specific points on a tibia and/or femur; where the instrument used (i.e., a pointer) comprises a tracking device thereon, and each one of the femur and tibia also have tracking devices affixed thereto. Additionally, a “resection guide” to which a tracking marker is affixed (see Figures 13A-D). Paragraph 167 teaches that there are two schematic views of the femur shown in Figure 16A, but that these “need not be a true depiction of the patient's anatomy”. “The resection guide for a femur 1602 may be placed on or proximate the femur 1602. The augmented reality headset may recognize the fiducials of the resection marker removably coupled to the resection guide and may use the position (e.g., location and orientation) of the fiducials to generate actual resection plane information—such as actual resection plane 1606” (see paragraph 168). And paragraph 68 teaches that “the medical provider can have the headset generate a model of the anatomy and may update that model intra-operatively as the anatomy changes during the surgery (e.g., due to resection of bones)”. However, the Young reference fails to teach the generation of at least two planar profiles from a generated mesh and displaying an updated version of the at least two planar profiles based on receiving updated tracking information.
US Patent Pub. No. 2008/0319448 to Lavallee et al. teaches a system for determining an optimal position for an implant and illustrates the use of a heat map in Figure 4 with regard to the tibial and/or femoral surface. However, there is no discussion of updating tracking information of the patient’s anatomy and/or surgical instruments and generation of updated planar profiles from meshes based on an updated tracking.
US Patent Pub. No. 2009/0043556 to Axelson et al. teaches A system for virtually planning a size and position of a prosthetic implant for a bone on a patient includes a database containing pre-defined form factor information for a plurality of different implants and a circuit for obtaining surface shape information of the bone. “On each screen 208a and 208b, visual indications 214, such as dots, are displayed superimposed over the bone that show what survey data points have been obtained and the approximate positions thereof. In one embodiment, survey data points are acquired using a digitizer mechanism, such as the pointer 46” (see paragraph 60). In Fig. 17, the flexion/extension gaps are calculated. However, there is no discussion of updating tracking information of the patient’s anatomy and/or surgical instruments and generation of updated planar profiles from meshes based on an updated tracking.
KR 10-1190973 to Mun Joung et al. teaches “an apparatus and method for displaying an amputation plane of a knee joint are provided to have help from a system by matching a part to be cut with a cutting guide line.” Figure 1 illustrates a tracked surgical instrument, and tracked femur and tibia. However, there is no discussion of updating tracking information of the patient’s anatomy and/or surgical instruments and generation of updated planar profiles from meshes based on an updated tracking.
US Patent Pub. No. 2017/0340389 to Otto et al. teaches a method of generating resection plane data for use in planning an arthroplasty procedure on a patient bone, which includes generating a three-dimensional patient bone model from the patient data, the patient bone model including a polygonal surface mesh; identifying a location of a posterior point on the polygonal surface mesh; creating a three-dimensional shape centered at or near the location; identifying a most posterior vertex of all vertices of the polygonal surface mesh that may be enclosed by the three-dimensional shape; using the most posterior vertex as a factor for determining a posterior resection depth; and generating resection data using the posterior resection depth, the resection data configured to be utilized by a navigation system during the arthroplasty procedure (see Abstract). However, there is no discussion of updating tracking information of the patient’s anatomy and/or surgical instruments and generation of updated planar profiles from meshes based on an updated tracking.
EP 3858279 A1 to Van Tienen et al. teaches a system for sizing an implant on a bony surface in a joint. Figure 4 illustrates a shape model 201 of a tibia and plane 402. Figure 5 illustrates a top view of Figure 4. “The curvature of the tibial plateau may be resection guidedetermined based on the points in this region using image analysis techniques. This fitting may be performed using, for example, a least sum of squared errors optimization to minimize the distance of the points to the plane. An initial position of the plane may be determined with respect to the reference model. The plane may be iteratively moved and/or rotated in order to minimize the sum of squared errors.” “Fig. 5 shows the intersection points 404 thus found, which may be arranged along a curve.” However, there is no discussion of updating tracking information of the patient’s anatomy and/or surgical instruments and generation of updated planar profiles from meshes based on an updated tracking.
US Patent 11,160,568 to Park teaches a cutting jig and corresponding method of manufacture. “Curvilinear surfaces are characterized by custom patient-specific parameters derived from measurements obtained from selected image slices of a patient's joint region” (see Abstract). Figures 7-8, for example, illustrate multiple non-planar “profiles” of the patient’s anatomy. However, these are used in manufacture of the jig. These are not based on any tracking of a surgical instrument, nor on updated tracking information of anatomy and surgical instruments.
Additional prior art considered to be within the general area of technology as that of the instant application, but also failing to teach the updating tracking information of the patient’s anatomy and/or surgical instruments and generation of at least two updated planar profiles from meshes based on an updated tracking can be found on the PTO-892.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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