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 .
Response to Amendment
The amendment filed 6 October, 2025 has been entered.
The amendment of claims 1, 11, and 20 has been acknowledged.
The cancellation of claims 2 – 10 has been acknowledged.
Response to Arguments
Applicant’s arguments, see page 6, section “Claim Rejections – 35 USC 103”, filed 6 October, 2025 with respect to the rejection of claims 1 – 5, 16, 17, 19, and 20 has been fully considered and is persuasive. The rejection of claims 1 – 5, 16, 17, 19, and 20 under 35 U.S.C. § 102 is withdrawn. However, upon further examination a new rejection is made for claims 1 – 5, 16, 17, 19, and 20 under 35 U.S.C. § 103.
Applicant’s arguments, see page 8, section “Claim Rejections – 35 USC 103”, filed 6 October, 2025 with respect to the rejection of claim 11 has been fully considered but is not persuasive.
Applicant states on page 8 of the reply filed 6 October, 2025 that a skilled person would not be motivated to modify the method of Musahl so as to monitor “position, orientation, alignment, and change of position, orientation and alignment in relationship to the patient and the surgical site of each additional OHMD (Optical Head Mounted Display)” as both references operate in different clinical domains and serve different end goals. Specifically, the Musahl reference involves dynamic joint manipulation and observation whereas Lang teaches a surgical registration system that includes spatial correlation of preoperative models. Additionally, the applicant states on page 10 of the reply that the broad teaching of “tissue volume” in ¶ 0728 of Lang is only a generalized assertion, and not a specific assertion of determining change in volume of the tissue. The examiner respectfully disagrees.
Primary art Musahl et al (U.S. Patent Publication No. 2018/0214074 A1, hereinafter “Musahl”) teaches a method of monitoring a joint by marking the subject’s joint and tracking it across images captured of the subject. Lang et al (U.S. Patent Publication No. 2017/0258526 A1, hereinafter “Lang”) teaches a system for monitoring a subject by comparing real time images captured against digital representations of virtual pro-operative images. The system of lang is used for monitoring joints as well as the tissue of a subject to determine changes between the pre-operative data and the data collected in real time, see ¶ 0728 “The matching, superimposing and/or registering of the live data of the patient and the virtual data of the patient after the surgical tissue alteration can be manual, semiautomatic or automatic using information about the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features.”. Table 6 of Lang describes a steps applied to patient tissue which is monitored by the camera system including a step of “placement of registration marker or calibration phantom on the tissue surface or inside the tissue”. This is understood by the examiner to be a process of using a marker placed on the tissue of the subject to track and monitor the changes in tissue volume of a subject during various procedures. As such, it is understood that one skilled in the art would be able to incorporate aspects of Lang, specifically, the utilizing of a skin marker to track over time changes in the volume of a subjects skin.
With respect to applicants statement that Lang does not teach “determining change in volume of the tissue ‘based on the change in position of the at least one marking’”, ¶ 0728 states the following “The matching, superimposing and/or registering of the live data of the patient and the virtual data of the patient after the surgical tissue alteration can be manual, semiautomatic or automatic using information about the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features. Automated re-registration can, for example, be performed using an image and/or video capture system integrated into, attached to or separate from the OHMD which can capture information about the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features in the live patient data after the surgical alteration and compare the information to information in the virtual data of the patient, e.g. for the virtual data after performing the comparable step in a virtual surgical plan.”. This paragraph clearly defines that the image or video capture system matches, superimposes, and/or registers live data of the patient with virtual data of the patient. Specifically regarding the information about “surgically altered tissue or tissue surface, or tissue contour, or tissue perimeter or tissue volume or other tissue features (emphasis added)”. Again, table 6 describes the various steps applied to the patient tissue including “placement of a registration marker or calibration phantom on the tissue surface or inside the tissue”. This is clear in describing a process of comparing skin tissue which has been marked by a registration marker in images captured to determine information about the tissue volume.
Claim Objections
Claim 11 is objected to because of the following informalities:
Line 2 states “plurality of fiducial”, examiner believes this should say “plurality of fiducials”
Appropriate correction is required.
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.
Claims 1, 16, 17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Musahl et al (U.S. Patent Publication No. 2018/0214074 A1, hereinafter “Musahl”) in view of Lang et al (U.S. Patent Publication No. 2017/0258526 A1, hereinafter “Lang”).
Regarding claim 1, Musahl teaches a method of performing a physiological measurement, the method comprising:
applying a first marker to a portion of a tissue (¶ 0035: In order to accurately measure motion (e.g., lateral pivot shift) using video, markers can be affixed externally to the patient's skin in a noninvasive manner), the first marker having a pattern of markings thereon, each marking of the pattern of markings having an initial position (¶ 0035: While a variety of marking schemes can be supported by innovations herein, an example can include using circular stickers in a predetermined pattern.);
capturing an image of the pattern of markings at a first time after applying the first marker to the tissue (¶ 0036: A digital camera can be positioned to capture motion of the markers and other aspects during a test.), at least one marking of the pattern of markings having a subsequent position at the first time when the image is captured (¶ 0036: For example, in a pivot shift test, the video camera can record the lateral aspect of the knee during the pivot shift test.);
determining a change of position of the at least one marking by comparing the subsequent position of the at least one marking in the captured image to the initial position of the at least one marking (¶ 0038: With respect to the lateral pivot shift test, the anteroposterior (AP) position of the femur can be calculated on consecutive still images extracted from the video recording. AP translation over time can be recorded and associated with various diagnoses.); and
based on the change of position of the at least one marking, determining the physiological measurement of the tissue (¶ 0039: A sudden anterior translation of the distal femur can be associated with various grades or measurements indicative of ACL injury. In studies and/or embodiments, the sudden anterior translation of the lateral epicondyle can be on average 3.7±2.1 mm and occurred within 0.2±0.1 seconds from the start of such anterior translation. These shifts are successfully detected in accordance with disclosures herein, facilitating a simple and affordable method to evaluate the lateral pivot shift test.).
Musahl does not explicitly teach wherein the physiological measurement is a change in volume of the tissue.
However Lang does teach wherein the physiological measurement is a change in volume of the tissue (¶ 0728: Automated re-registration can, for example, be performed using an image and/or video capture system integrated into, attached to or separate from the OHMD (optical head mounted display) which can capture information about the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features in the live patient data after the surgical alteration and compare the information to information in the virtual data of the patient, e.g. for the virtual data after performing the comparable step in a virtual surgical plan. Automated re-registration can, for example, be performed using an image and/or video capture system integrated into, attached to or separate from the OHMD which can capture information about the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features in the live patient data after the surgical alteration and compare the information to information in the virtual data of the patient, e.g. for the virtual data after performing the comparable step in a virtual surgical plan.).
Musahl and Lang are considered to be analogous art as both pertain to fiducial patterns being applied to a person. Therefore, it would have been obvious to one of ordinary skill in the art to combine the quantified injury diagnostics (as taught by Musahl) and the devices and methods for surgery (as taught by Elliott) before the effective filing date of the claimed invention. The motivation for this combination of references would be the method of Lang enables the position, orientation, alignment, and change in position, orientation and alignment in relationship to the patient and the surgical site of each additional OHMD can be individually monitored thereby maintaining alignment and superimposition of corresponding structures in the live data of the patient and the virtual data of the patient for each additional OHMD irrespective of their position, orientation, and alignment in relationship to the patient and/or the surgical site. (See ¶ 0146).
This motivation for the combination of Musahl and Lang is supported by KSR exemplary rationale (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. MPEP 2141 (III).
Regarding claim 16, the Musahl and Lang combination teaches the method of claim 1.
Additionally, Musahl teaches wherein the pattern of markings includes a plurality of dots and a plurality of fiducials (¶ 0043: Markers, as described herein, are visible, noninvasive, external markings on a patient. Markers can include, but are not limited to, stickers, ink, and other identifiable visual features. Markers can be included in all shapes and sizes. For example, solid or outlined shapes such as circles, rectangles, triangles, and others can be affixed or drawn on bodily landmarks or arbitrary locations. In alternative examples, various lined, grid, or other patterns can be affixed or drawn.) .
Regarding claim 17, the Musahl and Lang combination teaches the method of claim 16.
Additionally, Musahl teaches wherein the plurality of fiducials each have a cross shape (¶ 0043: In alternative examples, various lined, grid, or other patterns can be affixed or drawn.).
Regarding claim 19, the Musahl and Lang combination teaches the method of claim 16.
Additionally, Musahl teaches wherein determining the change of position of the at least one marking includes comparing a subsequent position of at least one feature of at least one of the fiducials in the captured image to an initial position of the at least one feature of the of at least one of the fiducials in a template image (¶ 0036: A digital camera can be positioned to capture motion of the markers and other aspects during a test. For example, in a pivot shift test, the video camera can record the lateral aspect of the knee during the pivot shift test.; ¶ 0038: With respect to the lateral pivot shift test, the anteroposterior (AP) position of the femur can be calculated on consecutive still images extracted from the video recording. AP translation over time can be recorded and associated with various diagnoses.; ¶ 0052: In a detailed example of processing component 120 determining image parameters, a marker can be a circle with a diameter of one-half inch. With this information provided, processing component 120 can utilize images from capture component 110 (which, for example, may show the marker as an oval if the capture component does not view the marker straight-on) to determine an angle to the target and adjust calculations accordingly. Further, by being provided information (e.g., that the markers are one-half inch in diameter), a scale can be defined relative to the known-sized markers.).
Regarding claim 20, the Musahl and Lang combination teaches a system for performing a physiological measurement of a tissue of a person, the system comprising:
a computer processor coupled to a memory (¶ 0105: With reference to FIG. 10, the exemplary environment 1000 for implementing various aspects of the innovation includes a computer 1002, the computer 1002 including a processing unit 1004, a system memory 1006 and a system bus 1008.), wherein the computer processor is programmed to perform a physiological measurement by:
receiving image data from a patient device, the image data including a pattern of markings of a marker on the tissue at a first time after applying the marker to the portion of the tissue ¶ 0036: A digital camera can be positioned to capture motion of the markers and other aspects during a test.;
determining a change of position of at least one marking of the pattern of markings by comparing a subsequent position of the at least one marking to an initial position of the at least one marking (¶ 0038: With respect to the lateral pivot shift test, the anteroposterior (AP) position of the femur can be calculated on consecutive still images extracted from the video recording. AP translation over time can be recorded and associated with various diagnoses.); and
based on the change of position of the at least one marking, determining the physiological measurement of the person (¶ 0039: A sudden anterior translation of the distal femur can be associated with various grades or measurements indicative of ACL injury. In studies and/or embodiments, the sudden anterior translation of the lateral epicondyle can be on average 3.7±2.1 mm and occurred within 0.2±0.1 seconds from the start of such anterior translation. These shifts are successfully detected in accordance with disclosures herein, facilitating a simple and affordable method to evaluate the lateral pivot shift test.),
additionally, Lang teaches the physiological measurement being a change in volume of the tissue (¶ 0728: Automated re-registration can, for example, be performed using an image and/or video capture system integrated into, attached to or separate from the OHMD (optical head mounted display) which can capture information about the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features in the live patient data after the surgical alteration and compare the information to information in the virtual data of the patient, e.g. for the virtual data after performing the comparable step in a virtual surgical plan. Automated re-registration can, for example, be performed using an image and/or video capture system integrated into, attached to or separate from the OHMD which can capture information about the surgically altered tissue or tissue surface or tissue contour or tissue perimeter or tissue volume or other tissue features in the live patient data after the surgical alteration and compare the information to information in the virtual data of the patient, e.g. for the virtual data after performing the comparable step in a virtual surgical plan.).
Claims 12, 13, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Musahl et al (U.S. Patent Publication No. 2018/0214074 A1, hereinafter “Musahl”) in view of Lang et al (U.S. Patent Publication No. 2017/0258526 A1, hereinafter “Lang”) and further in view of Daon et al (U.S. Patent Publication No. 2013/0131505 A1, hereinafter “Daon”).
Regarding claim 12, the Musahl and Lang combination teaches the method of claim 1.
Musahl does not explicitly teach further comprising, prior to applying the marker to the portion of the tissue, applying a stencil to the portion of the tissue, the stencil having the pattern of markings cut out to provide for the semi-permanent ink to pass through openings forming the pattern of markings and into the tissue.
However Daon does teach further comprising, prior to applying the marker to the portion of the tissue, applying a stencil to the portion of the tissue, the stencil having the pattern of markings cut out to provide for the semi-permanent ink to pass through openings forming the pattern of markings and into the tissue (¶ 0008: The pattern may be configured to be transferable from a transfer film to the skin, or may be directly applied to the skin through a mask or a stencil bearing the multi-element fiducial pattern.).
Musahl and Daon are considered to be analogous art as both pertain to fiducial patterns being applied to a person. Therefore, it would have been obvious to one of ordinary skill in the art to combine the quantified injury diagnostics (as taught by Musahl) and the surgical location monitoring system (as taught by Daon) before the effective filing date of the claimed invention. The motivation for this combination of references would be the method of Daon has known configurations so that observational data and/or tracking markers can be precisely mapped to the coordinate system. (See ¶ 0061).
This motivation for the combination of Musahl and Daon is supported by KSR exemplary rationale (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. MPEP 2141 (III).
Regarding claim 13, the Musahl, Lang, and Daon combination teaches the method of claim 12.
Additionally, Daon teaches wherein the tissue is adjacent to a surgical incision (¶ 0006: The present invention involves a surgical monitoring system comprising a fiducial reference configured for (1) applying to a location on skin proximate a surgical site, (2) for having a three-dimensional location and orientation determinable based on scan data of the surgical site, and (3) for having the three-dimensional location and orientation determinable based on image information about the surgical site.).
Regarding claim 15, the Musahl and Lang combination teaches the method of claim 1.
Additionally, Daon teaches wherein the pattern of markings includes straight line segment markings and curved line segment markings (Figure 7A – 7F; ¶ 0081: In one embodiment, the computer system has a predetermined knowledge of the configuration of multi-element fiducial pattern 710 and examines slices of a scan of the surgical site to locate pattern segments 720 of multi-element fiducial pattern 710 based on one or more of the radio-opacity density of the material of the pattern segments 720, their shapes and their unique tracking markers 740.; Examiner’s note: The markings indicated in Figure 7A show letters which contain straight line segment markings as well as curved line segment markings.).
Regarding claim 18, the Musahl and Lang combination teaches the method of claim 16.
Additionally, Musahl teaches wherein the pattern includes three fiducials (¶ 0035: For example, in a lateral pivot shift test, three skin markers can be attached to bony landmarks on the lateral side of the knee joint.),
Additionally, Daon teaches each pattern having a cross shape (Figure 9C and 9D; ¶ 0094: FIGS. 9C and 9D illustrate a similar use of constellations, wherein skin 912 of the surgical site receives transfer member 902, for example incise film or transfer tape, which bear elements 922. Elements 922, in addition to having radio-opaque qualities, also are visible to tracker 932 so that the location of elements 922, and their corresponding constellations 942 and 952, may be apparent on scans and image data.)
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Musahl et al (U.S. Patent Publication No. 2018/0214074 A1, hereinafter “Musahl”) in view of Daon et al (U.S. Patent Publication No. 2013/0131505 A1, hereinafter “Daon”) and further in view of Knowlton et al (U.S. Patent Publication No. 2021/0085356 A1, hereinafter “Knowlton”).
Regarding claim 14, the Musahl, Lang, and Daon combination teaches the method of claim 13.
Neither Musahl nor Daon teaches wherein the surgical incision was used during one of:
a breast reconstruction or augmentation surgery;
a facial plastic or reconstruction surgery;
a cardio-thoracic surgery such as a sternal repair after coronary artery bypass graft surgery (CABG); and
a hernia surgery.
However Knowlton teaches wherein the surgical incision was used during one of:
a breast reconstruction or augmentation surgery (¶ 0042: Plastic surgery procedures have been developed to resect the redundant lax skin. These procedures must employ long incisions that are typically hidden around anatomical boundaries such as the ear and scalp for a facelift and the inframammary fold for a breast uplift (mastopexy).; ¶ 0511: The harvest pattern comprises indicators or markers on a skin surface on at least one of the donor site and the recipient site, but is not so limited. The markers include any compound that may be applied directly to the skin to mark an area of the skin.);
a facial plastic or reconstruction surgery (¶ 0042: “Facial Cervical Rhytidoplasty” as used herein includes a procedure known as a facelift. However, a major part of this aesthetic surgical procedure involves the restoration of the cervical-mandibular angle in the neck. A facelift is performed through a curvilinear incision around the ear and extending into temporal/occipital scalp.; ¶ 0511: The harvest pattern comprises indicators or markers on a skin surface on at least one of the donor site and the recipient site, but is not so limited. The markers include any compound that may be applied directly to the skin to mark an area of the skin.);
a cardio-thoracic surgery such as a sternal repair after coronary artery bypass graft surgery (CABG); and
a hernia surgery.
Musahl and Knowlton are considered to be analogous art as both pertain to fiducial patterns being applied to a person. It would have been obvious to one of ordinary skill in the art to combine the quantified injury diagnostics (as taught by Musahl) and pixel array medical systems (as taught by Knowlton) before the effective filing date of the claimed invention because such a modification is the result of combining prior art elements according to known methods to yield predictable results. More specifically, Musahl as modified by Knowlton can yield a predictable result of performing various surgeries to be performed utilizing a marker placed on the patient’s skin. Thus, a person of ordinary skill would have appreciated including in Musahl the ability to do a breast reconstruction or augmentation or facial plastic or reconstruction surgery since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
This motivation for the combination of Musahl, Daon, and Knowlton is supported by KSR exemplary rationale (A) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. MPEP 2141 (III).
Allowable Subject Matter
Claim 11 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhao et al (U.S. Patent Publication No. 2023/0196707 A1) teaches a plurality of fiducial patterns, including cross shaped fiducial markers within a grid of dots.
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.
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/ANDREW B. JONES/Examiner, Art Unit 2667
/MATTHEW C BELLA/Supervisory Patent Examiner, Art Unit 2667