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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 1, 2026 has been entered.
Response to Amendment
The amendment filed March 4, 2026 has been entered. Claims 1-6, 9-16, 27, and 47 are pending, with claim 47 being withdrawn from examination. Examiner acknowledges Applicant’s cancellation of claims 7 and 8 and incorporation of analogous limitations thereof into independent claims 1, 16, and 27.
In light of continued examination, the rejection under 35 U.S.C. 101 has been modified.
A new grounds of rejection under 35 U.S.C. 103 is presented responsive to Applicant’s amendments.
Response to Arguments
35 U.S.C. 101:
Regarding Applicant’s argument:
“… a monitoring process is improved by providing a system that only requires a patient to take a picture to determine different ranges of motion and/or healing progress. Therefore, the pending claims are not directed to an abstract idea since the claims at least improve another technology or technical field, namely negative pressure wound therapy systems. See, MPEP § 2106.05(a).”
Negative pressure wound therapy is not recited in the independent claims, nor is healing progress. The act of taking a picture is performed by a well-understood, routine, and conventional device, e.g., a camera of a smartphone as described in Applicant’s Specification. Providing a drape with one or more locators is also considered well-understood, routine, and conventional in the motion capture arts. Such additional elements are solely used in data-gathering activity to provide data to a conventional processing device to carry out steps of the abstract idea. Examiner notes that an improvement cannot come from the abstract idea itself, but from an additional element. Applicant has failed to identify what particular additional element provides substantive improvement as opposed to what would occur with carrying out abstract idea steps with conventional computing devices and known data-gathering elements.
Examiner notes that claims 12-15 are not rejected under 35 U.S.C. 101 in light of the updated rejection. Each of claims 12-15 recite additional structural limitations which are defined relative to the drape such that these structures in combination cannot be considered well-understood, routine, and conventional, nor are they directed to purely data-gathering.
35 U.S.C. 103:
Applicant’s arguments with respect to claims rejected under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1-6, 9-11, 16, and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of the claims recites limitations which may be grouped as mental processes. Accordingly, each of the claims recites an abstract idea.
Independent claim 1 recites a system for calculating range of motion of a jointed limb of a patient, the system comprising:
a drape configured to be adhered to skin of the jointed limb of the patient, wherein the drape comprises a plurality of locators, wherein one or more first locators of the plurality of locators are configured to be positioned at an upper limb of the jointed limb, one or more second locators of the plurality of locators are configured to be positioned at a lower limb of the jointed limb, and one or more third locators are configured to be positioned at a joint of the jointed limb between the upper limb and the lower limb (additional element);
a personal computer device comprising an imaging device (additional element),
wherein the personal computer device is configured to:
record a first image of the joint of the jointed limb of the patient in a fully extended position with the imaging device (data-gathering);
record a second image of the joint of the jointed limb of the patient in a fully flexed position with the imaging device (data-gathering);
identify positions of the plurality of locators in both the first image and the second image (observation, evaluation, or judgement);
determine an extended angle of the joint of the jointed limb of the patient based on the identified positions of the plurality of locators in the first image (observation, evaluation, or judgement);
determine a flexed angle of the joint of the jointed limb of the patient based on the identified positions of the plurality of locators in the second image (observation, evaluation, or judgement);
determine a range of motion angle based on the extended angle and the flexed angle (observation, evaluation, or judgement),
perform a calibration process to determine offset amounts for any of the flexed angle, the extended angle, and the range of motion angle to account for orientation of the imaging device relative to the jointed limb, the calibration process including:
analyzing the first image and the second image to determine a difference in a shape of the plurality of locators relative to a known shape of the plurality of locators,
determining an orientation of the imaging device relative to the jointed limb based on the difference in the shape of the plurality of locators, and
determining an offset amount for any of the flexed angle, the extended angle, and the range of motion angle to account for the orientation of the imaging device relative to the jointed limb (observation, evaluation, or judgement).
Independent claim 16 recites a controller for calculating a range of motion of a jointed limb of a patient, wherein the controller is configured to perform steps encompassed by limitations recited by the personal computer device of claim 1. Examiner notes that independent claim 16 lacks the additional element of a drape comprising a plurality of locators.
Independent claim 27 recites a method for calculating range of motion of a jointed limb of a patient, the method comprising limitations encompassed by steps carried out by the personal computer device of claim 1. Examiner notes that independent claim 27 lacks the additional element of a drape comprising a plurality of locators.
Thus, streamlined analysis is provided for claim 1, encompassing analysis of independent claims 16 and 27.
As indicated above, independent claim 1 recites at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting generic computer components (i.e., “personal computer device” and “a controller”), can be grouped as a mental process (see italicized portions above), and is addressed as follows:
The limitation of identify positions of the plurality of locators in both the first image and the second image is plainly an abstract step of observation.
Each limitation reciting “determine” is an act of evaluation after the previous abstract step of observation.
Each limitation reciting “determining” is similarly treated, whereby such steps in the claimed calibration process requires no more than observation of two images, identification of a shape change, and determining relative orientation based on such shape change, then determining how such change in orientation affects a true value of various postures/poses of the jointed limb.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Dependent claims 2-6, and 9-11 recite limitations relating to data gathered, data-gathering components, or pre- or post-solution activity. Thus, the dependent claims amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use and are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed. These concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
More specifically:
Independent claim 1 recites the following additional elements:
a drape configured to be adhered to skin of the jointed limb of the patient, wherein the drape comprises a plurality of locators…
a personal computer device comprising an imaging device.
Independent claim 16 recites the following additional elements:
a controller;
an imaging device;
one or more first and second locators.
Independent claim 27 recites the following additional elements:
a plurality of locators;
a personal computer device comprising an imaging device.
Such additional element are a generically recited elements which do not improve the functioning of a computer or any other technology or technical field. The use of a plurality of locators is a data-gathering component well-known in the computer vision arts (see analysis under 2B below); thus, the claim is directed to acquiring data from sensors having no operative connection to the a controller or personal computer device besides communication of obtained data, which amounts to insignificant, extra-solution activity in the form of mere data gathering, which does not constitute an integration into a practical application. Although the elements directed to use in data-gathering may imply particular structure, their use in the mental process is merely extra-solution. See MPEP 2106.05(b).III:
“Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted)”
Both the controller and personal computer device are recited at a high-level of generality (i.e., as a generic processors and memory performing a generic computer function of performing calculations and storing data, respectively) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
Thus, such additional elements do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified generically recited elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea is not integrated into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application under because the claimed method and system merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer (e.g., controller and personal computer device as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract ideas identified above in the independent claims (and their respective dependent claims) are not integrated into a practical application.
Dependent claims 2-6, and 9-11, as stated in the analysis under Step 2A, Prong One, recite limitations relating to data gathered, data-gathering components, or pre- or post-solution activity.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
Independent claim 1 recites the following additional elements:
a drape configured to be adhered to skin of the jointed limb of the patient, wherein the drape comprises a plurality of locators…
a personal computer device comprising an imaging device.
Independent claim 16 recites the following additional elements:
a controller;
an imaging device;
one or more first and second locators.
Independent claim 27 recites the following additional elements:
a plurality of locators;
a personal computer device comprising an imaging device.
As per Applicant’s Paragraph 0078, a personal computer device comprising an imaging device is described as “(e.g., a smartphone, a tablet, a laptop computer, etc.).” Applicant’s disclosure is not particular regarding the particular structure of such devices. No special programming or algorithms is indicated for how such devices operate. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities for processing and imaging. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the personal computer device comprising an imaging device because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
Examiner notes that the above analysis of a personal computer device comprising an imaging device encompasses the broader additional element of a controller.
A drape as claimed as having a plurality of locators is claimed broadly enough such that it encompasses elements known from motion tracking and computer vision arts. For instance, an element which encompasses limitations of the drape is considered well-understood, routine, and conventional from at least:
Gordon et al. (US 20070206832 A1) – Paragraph 0003: “Motion capture systems are used to capture the movement of a real object and map it onto a computer generated object as a way of animating it. Such systems are often used in the production of motion pictures and video games for creating a digital representation of a person that is used as source data to create a computer graphics (CO) animation. In a typical system, an actor wears a suit having markers attached at various locations (e.g., having small reflective markers attached to the body and limbs) and digital cameras record the movement of the actor from different angles while illuminating the markers. The system then analyzes the images to determine the locations (e.g., as spatial coordinates) and orientation of the markers on the actor's suit in each frame. By tracking the locations of the markers, the system creates a spatial representation of the markers over time and builds a digital representation of the actor in motion. The motion is then applied to a digital model, which may then be textured and rendered to produce a complete CG representation of the actor and/or performance. This technique has been used by special effects companies to produce highly realistic animations in many popular movies.”
Examiner notes that the above analysis of a drape encompasses the broader additional elements of one or more first and second locators and a plurality of locators.
Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear from the claims themselves and the specification that these limitations require no improved computer resources and merely utilize already available computers with their already available basic functions to use as tools in executing the claimed process.
Dependent claims 2-6, and 9-11, again as stated in the analysis under Step 2A, Prong One, recite limitations relating to data gathered, data-gathering components, or pre- or post-solution activity.
Examiner notes that the dependent claims recite limitations which are extra-solution or part of the abstract idea itself do not constitute significantly more. See MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
The recitation of the above-identified additional limitations in the claims amount to mere instructions to implement the abstract idea on a computer using well-known components for requisite data-gathering. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
For at least the above reasons, the claims are directed to applying an abstract idea on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (joint motion analysis). That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself, or (ii) provide a technical solution to a problem in a technical field.
Therefore, none of the claims amounts to significantly more than the abstract idea itself.
Accordingly, the claims are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
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.
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.
Claim(s) 1-6, 10-11, 15-16, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20190066832 --as previously cited--, hereinafter referenced as "Kang" in view of US Patent Application Publication 20160220175 --as cited by applicant--, hereinafter referenced as "Tam", and in further view of US Patent Application Publication 20150335271, hereinafter referenced as “Lin”, and in further view of Mostafavi et al. (US 20030063292 A1) (hereinafter – Mostafavi).
With respect to claim 1, Kang teaches a system for calculating range of motion of a jointed limb of a patient (i.e., a system and method for detecting patient risk during a physical therapy program that includes determining an angular range of motion of a joint from a first and a second digital photographic image) (see Kang, abstract, par 0008-0009, 0017-0018, 0044, figs. 1A & 1B), the system comprising:
a personal computer device comprising an imaging device (i.e., a mobile computing device) (see Kang, par 0008-0009, figs. 1A & 1B), wherein the personal computer device is configured to:
record a first image of the joint of the jointed limb of the patient in a fully extended position with the imaging device (i.e., the patient records a digital photographic image of their joint in extension) (see Kang, 0008, 0044, figs. 1A, 1B & 2-3);
record a second image of the joint of the jointed limb of the patient in a fully flexed position with the imaging device (i.e., the patient records a digital photographic image of their joint in flexion) (see Kang, 0008, 0044, figs. 1A, 1B & 2-3);
identify positions of both the first image and the second image (i.e., wherein the mobile computing device is further placed in a plurality of positions proximal to the joint of interest to identify and record an orientation of the mobile computing device with respect to the patient’s joint for calculating a tangential plane representing the contact point of the mobile computing device at the patient’s limb that is used to calculate angles of extension and/or flexion of the patient’s joint) (see Kang, par 0064-0065, 0068-0071 & 0073, figs. 2 & 3);
determine an extended angle of the joint of the jointed limb of the patient based on the identified positions of the first image (i.e., the system and method determines an angle of extension based upon the identified positions and orientations of the patient’s joint during extension) (see Kang, par 0009 & 0068-0073, figs. 2 & 3);
determine a flexed angle of the joint of the jointed limb of the patient based on the identified positions of the second image (i.e., the system and method determines an angle of flexion based upon the identified positions and orientations of the patient’s joint during flexion) (see Kang, par 0009 & 0068-0073, figs. 2 & 3);
and determine a range of motion angle based on the extended angle and the flexed angle (i.e., the system and method calculates an angular range of motion of the joint as a difference between the angle of extension and the angle of flexion) (see Kang, par 0009 & 0068-0073, figs. 2 & 3).
Kang fails to teach a drape configured to be adhered to skin of the jointed limb of the patient, wherein the drape comprises a plurality of locators, wherein one or more first locators of the plurality of locators are configured to be positioned at an upper limb of the jointed limb, one or more second locators of the plurality of locators are configured to be positioned at a lower limb of the jointed limb, and one or more third locators are configured to be positioned at a joint of the jointed limb between the upper limb and the lower limb. Kang further fails to teach the personal computer device identifies positions of the plurality of locators in both the first image and the second image, determines the extended angle of the joint of the jointed limb of the patient based on the identified positions of the plurality of locators in the first image, and determines the flexed angle of the patient's joint based on the identified positions of the locators of the second image.
Tam teaches an apparatus and method for range of motion tracking with integrated reporting that comprises a positioning device such as a traditional knee brace (i.e., a drape that adheres to the limb of the patient) (see Tam, par 0044) that is used to place multiple two-dimensional markers, such as circles, or three-dimensional markers, such as spheres, around a joint of a patient, wherein the markers have a fixed relation to each other (see Tam, par 0048, figs. 2 & 3). The markers are used to denote positions along the joint of the patient (see Tam, par 0044), when the joint articulating through a range of motion is recorded on a video camera of a mobile device (see Tam, par 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kang such that it comprises a drape configured to be adhered to the skin of the jointed limb of the patient, wherein the drape comprises a plurality of locators, wherein one or more first locators are configured to be positioned at an upper limb of the jointed limb and one or more second locators of the plurality of locators are configured to be positioned at a lower limb of the jointed limb, and further such that the personal computer device identifies positions of the plurality of locators in both the first image and the second image, determines the extended angle of the joint of the jointed limb of the patient based on the identified positions of the plurality of locators in the first image, and determines the flexed angle of joint of the jointed limb of the patient based on the identified positions of the plurality of locators in the second image because the use of locators (i.e., markers) enables tracking of relevant positions near/around the joint such that video of the joint articulating through a range of motion can be recorded, and joint flexion, joint extension, and overall range of motion can be calculated based on the positions of the markers in the video using a software program (see Tam, par 0044, 0047-0051).
Kang as modified by Tam fails to teach one or more third locators are configured to be positioned at a joint of the jointed limb between the upper limb and the lower limb.
Lin teaches a system and method for evaluating range of motion of a subject, wherein three markers are used to capture images of motion of a user’s limb, such as an arm, when the subject is completing exercises (see Lin, abstract, par 0027, fig. 1). The markers are attached to the shoulder, wrist, and elbow of the subject, therefore the markers are attached to an upper limb (i.e., shoulder), joint (i.e., elbow), and a lower limb (i.e., wrist) (see Lin, par 0016, 0027, 0037, fig. 1). The attachment of the marker to joints of the subject permits the evaluation of different exercises, such as shoulder abduction exercise, shoulder flexion exercise, shoulder internal/external rotation exercise, and elbow flexion exercise in the evaluation of the range of motion of the subject (see Lin, par 0029, figs. 2a-2e).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kang as modified by Tam such that one or more third locators are configured to be positioned at a joint of the jointed limb between the upper limb and the lower limb because one or more third locators configured to be positioned at a joint of the jointed limb between the upper limb and the lower limb permits the evaluation of different exercises that involve the joint of interest, such as abduction, rotation, and flexion exercises in the evaluation/determination of the range of motion of the subject (see Lin, par 0029, figs. 2a-2e).
Kang as modified by Tam and Lin does not teach the invention wherein the personal computer device is configured to:
perform a calibration process to determine offset amounts for any of the flexed angle, the extended angle, and the range of motion angle to account for orientation of the imaging device relative to the jointed limb, the calibration process including:
analyzing the first image and the second image to determine a difference in a shape of the plurality of locators relative to a known shape of the plurality of locators,
determining an orientation of the imaging device relative to the jointed limb based on the difference in the shape of the plurality of locators, and
determining an offset amount for any of the flexed angle, the extended angle, and the range of motion angle to account for the orientation of the imaging device relative to the jointed limb.
Such a process is known from Mostafavi (Paragraph 0041: “According to one embodiment, the pixel coordinates of each marker in the video frame are tracked. The distance in the pixel domain between the two markers for each video frame is thereafter measured. The known physical distance of the two markers is divided by the measured distance to provide the scale factor for transforming the incremental motion of the block in the direction of the line connecting the two markers. This scale factor is updated for each new video frame and is used to transform the incremental motion of each marker from pixel domain to the physical domain. The transformation accounts for changes in the camera viewing angle, marker block orientation, and its distance to the camera during motion tracking”).
Examiner notes that application of the process of Mostafavi to the computer-vision tracking of limb motion in the modified Kang results in determination of an offset amount for any of the flexed angle, the extended angle, and the range of motion angle to account for the orientation of the imaging device relative to the jointed limb since the process of Mostafavi accounts for incremental motion of markers, such as the one attached to the claimed drape, and accounts for changes in orientation relative to the claimed imaging device. Additional pertinent art of record are cited in the Conclusion which teach a similar process.
With respect to claim 2, Kang as modified by Tam, Lin, and Mostafavi teaches the system of claim 1. Kang further teaches the personal computer device is a mobile device with an application configured to determine the range of motion angle (see Kang, par 0014, 0017, 0033, 0105).
With respect to claim 3, Kang as modified by Tam, Lin, and Mostafavi teaches the system of claim 1. Kang as modified by Tam and Lin further teaches the identified positions of the plurality of locators in the first image and the identified positions of the plurality of locators in the second image are identified based on image data of the first image and the second image (i.e., positions of markers are identifiable in video of the joint articulating through a range of motion) (see Tam, par 0048).
With respect to claims 4-6, Kang as modified by Tam, Lin, and Mostafavi teaches the system of claim 1. Kang further teaches the personal computer device is configured to generate a report and control a display screen to display the report (i.e., the personal computer device is configured to generate notifications and/or visualizations such as graphs of various patient data) (see Kang, par 0094-0095), the report comprises any of the range of motion angle, tabular historical information of the range of motion angle, graphical historical information of the range of motion angle, and improvements in the range of motion angle over time (i.e., the generated visualizations include a graph containing the measured range of motion in the joint of interest in one degree of freedom) (see Kang, par 0094-0095), and further the personal computer device is configured to provide the report to a clinician device (i.e., notifications of patient data are sent to a care provider’s mobile computing device) (see Kang, par 0094-0095).
With respect to claim 9, Kang as modified by Tam, Lin, and Mostafavi teaches the system of claim 1. Mostafavi, in teaching further detail related to the modification, further teaches wherein the difference in the shape of the plurality of locators is determined based on one or more initially recorded images (see citation of claim 1).
With respect to claim 10, Kang as modified by Tam, Lin, and Mostafavi teaches the system of claim 1. Kang further teaches the personal computer device is configured to provide a notification to the patient to record the first image and the second image (i.e., the patient is prompted to record the first and the second digital photographic images of the joint in flexion and extension) (see Kang, abstract, par 0008, 0017, 0049, 0051).
With respect to claim 11, Kang as modified by Tam, Lin, and Mostafavi teaches the system of claim 1. Kang further teaches the personal computer device is further configured to generate a plurality of centerlines to determine the extended angle and the flexed angle (see Kang, step 160 (S160) of fig. 1B, S154-S155, S157-S158 & S162 of fig. 2, par 0008-0009, 0021, 0044, 0064, 0073).
With respect to claim 15, Kang as modified by Tam, Lin, and Mostafavi teaches the system of claim 1, but fails to teach the system comprises a dressing, the dressing comprising the drape and a manifold layer.
Tam teaches the positioning device such as a knee brace (i.e., a drape with a manifold layer) can be placed on or near a wound dressing such that tracking devices can be placed (see Tam, par 0044) to enable tracking of relevant positions near/around the joint such that video of the joint articulating through a range of motion can be recorded, and joint flexion, joint extension, and overall range of motion can be calculated based on the positions of the markers in the video using a software program (see Tam, par 0044, 0047-0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kang as modified by Tam, Lin, and Mostafavi such that the system comprises a dressing, the dressing comprising the drape and a manifold layer as taught by Tam, because that would enable tracking of relevant positions near/around the joint such that video of the joint articulating through a range of motion can be recorded, and joint flexion, joint extension, and overall range of motion can be calculated based on the positions of the markers in the video using a software program (see Tam, par 0044, 0047-0051).
With respect to claim 16, claim 16 recites method limitations encompassed by the citations of the rejection of claim 1. See rejection of claim 1.
With respect to claim 27, claim 27 recites method limitations encompassed by the citations of the rejection of claim 1. See rejection of claim 1.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20190066832 --as previously cited--, hereinafter referenced as "Kang" in view of US Patent Application Publication 20160220175 --as cited by applicant--, hereinafter referenced as "Tam", and in further view of US Patent Application Publication 20150335271, hereinafter referenced as “Lin”, and in further view of Mostafavi et al. (US 20030063292 A1) (hereinafter – Mostafavi), and further in view of US Patent Application Publication 20160346444 --as previously cited--, hereinafter referenced as "Zamierowski".
With respect to claim 12, Kang as modified by Tam, Lin, and Mostafavi teaches the system of claim 1. Kang as modified by Tam and Lin fails to teach the system comprises a negative pressure source configured to draw a negative pressure at a wound at the jointed limb.
Zamierowski teaches a negative pressure surface device 303 that is placed over intact skin for producing a therapy zone 326 wherein negative pressure is applied to the skin in the therapy zone (see Zamierowski, par 0087, fig. 23). The negative pressure surface device comprises an output port 310 that is configured for attachment to a negative pressure source (see Zamierowski, par 0087, fig. 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kang as modified by Tam, Lin, and Mostafavi such that the system comprises a negative pressure source configured to draw a negative pressure at a wound at the jointed limb because negative pressure therapy has been shown to significantly improve patient outcomes with respect to wound healing and repair across a wide range of medical conditions and treatment procedures (see Zamierowski, par 0005-0007).
With respect to claim 13, Kang as modified by Tam, Lin, Mostafavi, and Zamierowski teaches the system of claim 12. Kang as modified by Tam, Lin, Mostafavi, and Zamierowski fails to teach the system further comprises a canister configured to receive wound exudate.
Zamierowski teaches a cellular control system 120 that consists of pillars 122 on a scaffold 104 that fluidly connects to inflow and outflow conduits that facilitate moving fluid into and out of the therapy zone (see Zamierowski, par 0060, fig. 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kang as modified by Tam, Lin, Mostafavi, and Zamierowski such that the system further comprises a canister configured to receive wound exudate because fluid drainage/removal from a wound has been shown to achieve significant improvements in patient outcomes (see Zamierowski, par 0005-0007).
With respect to claim 14, Kang as modified by Tam, Lin, Mostafavi, and Zamierowski teaches the system of claim 13. Kang as modified by Tam, Lin, Mostafavi, and Zamierowski fails to teach the system further comprises a connector at the drape and a tubular member, wherein the connector is configured to fluidly couple the wound with the negative pressure source through the tubular member.
Zamierowski teaches a negative pressure surface device 303 that is placed over intact skin for producing a therapy zone 326 wherein negative pressure is applied to the skin in the therapy zone (see Zamierowski, par 0087, fig. 23). The negative pressure surface device comprises an output port 310 that is configured for attachment to a negative pressure source (see Zamierowski, par 0087, fig. 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Kang as modified by Tam, Lin, Mostafavi, and Zamierowski such that the system further comprises a connector at the drape and a tubular member, wherein the connector is configured to fluidly couple the wound with the negative pressure source through the tubular member because negative pressure therapy has been shown to significantly improve patient outcomes with respect to wound healing and repair across a wide range of medical conditions and treatment procedures (see Zamierowski, par 0005-0007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Amended claim limitations appear to be similarly known from motion capture and computer vision arts:
Stulpe US 20160166354 A1 – “For example, the size of the image appearance of the marker pattern can be used to determine the distance between the marker pattern and the imaging plane of the imaging unit, and a difference in shape of the image appearance of the marker pattern compared to its known shape (in particular when viewed in a direction perpendicular to a plane in which the marker pattern is arranged, in particular perpendicular to a carrier surface of the carrier part) may be used to determine the orientation of the marker pattern relative to the imaging plane.”
Gordon et al. (US 20070206832 A1) – Paragraph 0003: “Motion capture systems are used to capture the movement of a real object and map it onto a computer generated object as a way of animating it. Such systems are often used in the production of motion pictures and video games for creating a digital representation of a person that is used as source data to create a computer graphics (CO) animation. In a typical system, an actor wears a suit having markers attached at various locations (e.g., having small reflective markers attached to the body and limbs) and digital cameras record the movement of the actor from different angles while illuminating the markers. The system then analyzes the images to determine the locations (e.g., as spatial coordinates) and orientation of the markers on the actor's suit in each frame. By tracking the locations of the markers, the system creates a spatial representation of the markers over time and builds a digital representation of the actor in motion. The motion is then applied to a digital model, which may then be textured and rendered to produce a complete CG representation of the actor and/or performance. This technique has been used by special effects companies to produce highly realistic animations in many popular movies.”
Bishop et al. (US 20180293764 A1) – Abstract: “Techniques for creating a three dimensional model of an object and eliminate artifacts due to changes in orientation of the object between successive scans. Such techniques may be applied to line scans and slice scans of an object.”
Hillukka (US 20170165042 A1) – Paragraph 0115: “…an initial image is captured using the imaging system 102 to determine reference orientations of the orientation-indicating fiducial markers 354. Then, a series of images (e.g., a video) is captured as the orientation of the orientation-indicating fiducial markers 354 changes. The relative changes in the orientation between each pair of consecutively captured images can then be determined. In this manner, the changes to the orientation of the clutch 332 relative to the reference structure 330 can be determined as the patient's jaw moves.”
Ernst et al. (US 20130188830 A1) – Paragraph 0039.
Uyama et al. (US 20210398304 A1) – Paragraph 0099: “It is to be noted that the technique of generating the three-dimensional map information regarding the environment and specifying the self-position of the imaging apparatus 2000 by matching the feature points is generally called SLAM (Simultaneous Localization and Mapping) technique.”
Tian et al. (US 20200126297 A1) – Paragraph 0049: “In some embodiments, the patient's 3D human body mesh, the acupuncture points, and other treatment information are updated in real-time, as the patient shifts his body or change his posture, as the imaging sensors 106 change camera angles and/or zoom to capture 2D images of different portions of the patient's body, as the remote expert modifies the locations of the automatically identified acupuncture points or identifies a subset of the acupuncture points as targeted points for treatment, as the remote expert identifies or changes treatment procedures, and/or as a treatment procedure is performed or completed, etc.”
Madadin et al. (US 20180055706 A1) – Paragraph 0109: “… the calibration markings may enable the computing device 80 to determine the perspective angle of the camera, and adjust the scale accordingly in different regions of a picture.”
Mikhailov et al. (US 20150261291 A1) – Paragraph 0011: “The video frames are configured to capture markers on a head mounted display (HMD), and the markers on the HMD are analyzed in the captured video frames to determine position and orientation of the HMD for processing changes to scenes generated during rendering of multimedia content that is displayed by the HMD.”
Lang (US 20210137634 A1) – Figs. 13-16; Paragraph 0982.
Habibian et al. (US 20200051254 A1) – Abstract: “For example, an object motion model of the motion modeling system may first model the motion of the object, assuming the camera is not in motion, in order to identify the expected position of the object. A camera motion model of the motion modeling system may then update the expected position of the object, obtained from the object motion model, based on the motion of the camera.”
Schmidt et al. (US 20070280423 A1) – Paragraphs 0007-0009.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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, Alexander Valvis can be reached at (571) 272-4233. 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.
/JUSTIN XU/ Primary Examiner, Art Unit 3791
Prosecution Insights