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 .
This Office Action is responsive to the Response to Office Action filed June 3, 2025. The Examiner acknowledges the amendments to claims 1, 3, 8, 16, 23, 27, and 34, and the cancellation of claims 17-21, 24-26, 28-32, and 35-46. Claims 1-16, 22, 23, 27, 33, 34 and 47 are currently pending, with claim 47 being withdrawn.
Response to Arguments
Regarding the previous rejection of the claims under 35 USC 112(b), Applicant argues that the previous rejections of the claims under 35 USC 112(b) have been overcome by the amendments to the claims. Applicant’s arguments have been fully considered and are persuasive. The previous rejection of the claims under 35 USC 112(b) has been withdrawn.
Regarding the previous rejection of the claims under 35 USC 101, Applicant argues that the claims should not be rejected under 35 USC 101 because the claims recite limitations that cannot practically be performed in the human mind, such as "providing a plurality of locators", "capturing a first image", and "capturing a second image" as recited in claim 27. The Examiner respectfully disagrees, because the abstract ideas recited in the claims are determining an extended angle of a patient’s joint based on identified positions of locators of a first image, determining a flexed angle of the patient’s joint based on identified positions of locators of a second image, and determining a range of motion angle based on the extended angle and the flexed angle. These determination steps could practically be performed in the human mind because one can look at images and subsequently make determinations based upon information presented in those images. Therefore, the claims are still drawn to an abstract idea. Regarding Applicant's assertion that the human mind cannot "provid[e] a plurality of locators", "captur[e] a first image", and "captur[e] a second image", those limitations that Applicant referenced are additional elements that fail to integrate the judicial exception (i.e., the abstract idea) into a practical application because those limitations pertain to mere data gathering activity.
Regarding the rejection of the claims under 35 USC 101 for encompassing a human organism, Applicant's amendments have overcome this rejection, and as such this previous rejection has been withdrawn. See 35 USC 101 rejections.
Regarding the rejection of the claims under 35 USC 103, Applicant argues that Tam fails to remedy the deficiencies of Kang with respect to claim 1 because Tam does not describe at least "one or more third locators [that] are configured to be positioned at a joint of the jointed limb between the upper limb and the lower limb" as recited in claim 1. The Examiner agrees that Kang as modified by Tam fails to teach the aforementioned claim limitation, but disagrees that Tam teaches away from providing "one or more third locators [that] are configured to be positioned at a joint of the jointed limb between the upper limb and the lower limb", as paragraph 0046 of Tam that Applicant alleges teaches away from the aforementioned claim limitation teaches that if appropriate, the placement device can be designed to accommodate constraints of a patient such as a wound area as to minimize contact with the wound (see Tam).
Moreover, Applicant argues the Barral reference is unrelated to systems and methods for calculating range of motion of joints of a patient and does not describe the analyzing steps of claim 8, and further that the examiner identifies no need or problem that was recognized in the art, thus there is no apparent reason for a person having ordinary skill in the art to modify the combination of Kang and Tam based on Barral as the examiner suggests because there is no need or problem of disorientation for a system configured to determine a range of motion of a jointed limb of a patient. In response to applicant's argument that the Barral reference is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the Barral reference is reasonably pertinent to the particular problem with which the inventor was concerned because Barral teaches a system for the display of preoperative and intraoperative images that comprises changing the orientation of preoperative images by a surgeon or a controller if it becomes more desirable to show a different angle of the preoperative image model (see Barral, par 0029 & 0035). Furthermore, the preoperative image may be changed as a result of recognition of fiducial markers in the preoperative image, wherein once the fiducial markers are recognized, the orientation of the preoperative image is changed to best display the data (i.e., the orientation of the preoperative images is updated in accordance with the fiducial markers) (see Barral, par 0041 & 0043). This addresses a similar problem as the claimed invention because fiducial markers in images are used to determine and adjust an orientation of the images. Applicant alleges that there is no apparent reason for a person having ordinary skill in the art to modify the combination of Kang and Tam based on Barral as the examiner suggests because there is no need or problem of disorientation for a system configured to determine a range of motion of a jointed limb of a patient, however, the Examiner disagrees because Barral demonstrates the need for calibrating an imaging device such that the orientation of images obtained from it are in accordance with the plurality of locators.
As discussed above, Applicant’s arguments with respect to the rejection(s) of claim(s) 1, 16 & 27, as well as their dependents under 35 USC 103 over Kang in view of Tam have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly added claim limitations. See 35 USC 103 rejections.
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 1-16, 22-23, 27 & 33-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 27 follows.
Regarding claim 27, the claim recites a series of steps or acts, including determining an extended angle of a joint of a jointed limb of a patient based on identified positions of a plurality of locators of a first image, determining a flexed angle of the joint of the jointed limb of the patient based on identified positions of a plurality of locators of a second image, and determining a range of motion angle based on the extended angle and the flexed angle. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of determining an extended angle of a joint of a jointed limb of a patient based on identified positions of a plurality of locators of a first image, determining a flexed angle of the joint of the jointed limb of the patient based on identified positions of a plurality of locators of a second image, and determining a range of motion angle based on the extended angle and the flexed angle set forth judicial exceptions. These steps describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Therefore, the claim does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of providing a plurality of locators configured to be positioned on the jointed limb of the patient, capturing a first image of a joint of the jointed limb of the patient in a fully extended position, capturing a second image of the joint of the jointed limb of the patient in a fully flexed position, and identifying positions of the plurality of locators in both the first image and the second image. The providing, capturing, and identifying steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the providing, capturing, and identifying steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 1 & 16, the system and controller respectively recited in the claims are a generic device and a generic controller comprising generic components configured to perform the abstract idea. The recited locators and imaging device are generic sensors configured to perform pre-solutional data gathering activity, and the controller is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and data calibration. The providing, capturing, and identifying steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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) 1-7, 10-11, 15-16, 22, 27 & 33 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”.
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).
With respect to claim 2, Kang as modified by Tam and Lin 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 and Lin 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 and Lin 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 7, Kang as modified by Tam and Lin teaches the system of claim 1. Kang further teaches 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 (i.e., based on a known location of an IMU sensor in the mobile computing device, or based on a known offset between the IMU and a reference point, the system can calculate an orientation of the mobile computing device based upon the angle the IMU recorded when the mobile computing device was aligned with the patient’s body, such that the system can then estimate orientation and position of the mobile computing device and the surface of the patient’s body) (see Kang, par 0067).
With respect to claim 10, Kang as modified by Tam and Lin 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 and Lin 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 and Lin teaches the system of claim 1. Kang 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 such that the system comprises a dressing, the dressing comprising the drape and a manifold layer 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, Kang teaches a controller for calculating a range of motion of a jointed limb of a patient (i.e., a controller that executes 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, 0105, figs. 1A & 1B) wherein the controller is configured to:
record a first image of the joint of the jointed limb of the patient in a fully extended position with an imaging device (i.e., the patient records a digital photographic image of their joint in extension with a mobile device) (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 with a mobile device) (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 the controller identifies positions of the locators in both the first image and the second image, wherein the one or more locators includes one or more first locators configured to be positioned at an upper limb of the jointed limb, one or more second locators configured to be positioned at a lower limb of the jointed limb, and one or more third locators configured to be positioned at a joint of the jointed limb between the upper limb and the lower limb, determines the extended angle of the joint of the jointed limb of the patient based on the identified positions of the one or more locators of the first image, and determines the flexed angle of the patient's joint based on the identified positions of the one or more locators of the second image.
Tam teaches an apparatus and method for range of motion tracking with integrated reporting that comprises a positioning device (i.e., a traditional knee brace) (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 controller of Kang such that it identifies positions of the locators in both the first image and the second image, wherein the one or more locators includes one or more first locators configured to be positioned at an upper limb of the jointed limb, one or more second locators configured to be positioned at a lower limb of the jointed limb, determines the extended angle of the joint of the jointed limb of the patient based on the identified positions of the one or more locators of the first image, and determines the flexed angle of the patient's joint based on the identified positions of the one or more locators of 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) of the subject (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).
With respect to claim 22, Kang as modified by Tam and Lin teaches the controller of claim 16. Kang further teaches controller 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 (i.e., based on a known location of an IMU sensor in the mobile computing device, or based on a known offset between the IMU and a reference point, the system can calculate an orientation of the mobile computing device based upon the angle the IMU recorded when the mobile computing device was aligned with the patient’s body, such that the system can then estimate orientation and position of the mobile computing device and the surface of the patient’s body) (see Kang, par 0067).
With respect to claim 27, Kang teaches a method 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 method comprising:
capturing a first image of a joint of the jointed limb of the patient in a fully extended position with an imaging device (i.e., the patient records a digital photographic image of their joint in extension with a mobile device) (see Kang, 0008, 0044, figs. 1A, 1B & 2-3);
capturing 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 with a mobile device) (see Kang, 0008, 0044, figs. 1A, 1B & 2-3);
identifying positions of a plurality positions in 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);
determining 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);
determining a flexed angle of the patient's joint 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 determining 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 providing a plurality of locators configured to be positioned on the jointed limb of the patient, wherein one or more first locators of the plurality of 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 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 identifying positions of the plurality of locators in both the first image and the second image, determining the extended angle of the patient's joint based on the identified positions of the plurality of locators in the first image, and determining 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.
Tam teaches an apparatus and method for range of motion tracking with integrated reporting that comprises a positioning device (i.e., a traditional knee brace) (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 method of Kang such that it comprises providing a plurality of locators on the patient's jointed limb, wherein one or more of the locators are positioned at an upper limb of the jointed limb, and one or more of the locators are positioned at a lower limb of the jointed limb, and further such that the method comprises identifying positions of the plurality of locators in both the first image and the second image, determining the extended angle of the patient's joint based on the identified positions of the plurality of locators in the first image, and determining 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 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).
With respect to claim 33, Kang as modified by Tam and Lin teaches the method of claim 27. Kang further teaches the method comprises performing 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 (i.e., based on a known location of an IMU sensor in the mobile computing device, or based on a known offset between the IMU and a reference point, the system can calculate an orientation of the mobile computing device based upon the angle the IMU recorded when the mobile computing device was aligned with the patient’s body, such that the system can then estimate orientation and position of the mobile computing device and the surface of the patient’s body) (see Kang, par 0067).
Claim(s) 8-9, 23 & 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang in view of Tam and in further view of Lin as applied to claims 7, 22 & 33 above, and further in view of US Patent Application Publication 20190110855 --as previously cited--, hereinafter referenced as "Barral".
With respect to claims 8 & 9, Kang as modified by Tam and Lin teaches the system of claim 7. Kang as modified by Tam and Lin fails to teach the calibration process comprises: 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 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, 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, and wherein the difference in the shape of the locators is determined based on one or more initially recorded images.
Barral teaches a system for the display of preoperative and intraoperative images that comprises changing the orientation of preoperative images by a surgeon or a controller if it becomes more desirable to show a different angle of the preoperative image model (see Barral, par 0029 & 0035). Furthermore, the preoperative image may be changed as a result of recognition of fiducial markers in the preoperative image, wherein once the fiducial markers are recognized, the orientation of the preoperative image is changed to best display the data (i.e., the orientation of the preoperative images is updated in accordance with the fiducial markers) (see Barral, par 0041 & 0043).
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 and Lin such that the personal computer device is configured to perform a calibration process that comprises 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 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, 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, and wherein the difference in the shape of the locators is determined based on one or more initially recorded images because doing so prevents disorientation of a user when using medical images for medical purposes (i.e., prevents disorientation of a surgeon during surgery), and thus demonstrates the need for calibrating an imaging device such that the orientation of images obtained from it are in accordance with the plurality of locators (see Barral, par 0003-0005).
With respect to claim 23, Kang as modified by Tam and Lin teaches the controller of claim 22. Kang as modified by Tam and Lin fails to teach the calibration process comprises: analyzing the first image and the second image to determine a difference in a shape of the one or more locators relative to a known shape of the locators, determining an orientation of the imaging device relative to the jointed limb based on the difference in the shape of the one or more 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.
Barral teaches a system for the display of preoperative and intraoperative images that comprises changing the orientation of preoperative images by a surgeon or a controller if it becomes more desirable to show a different angle of the preoperative image model (see Barral, par 0029 & 0035). Furthermore, the preoperative image may be changed as a result of recognition of fiducial markers in the preoperative image, wherein once the fiducial markers are recognized, the orientation of the preoperative image is changed to best display the data (i.e., the orientation of the preoperative images is updated in accordance with the fiducial markers) (see Barral, par 0041 & 0043).
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 controller of Kang as modified by Tam and Lin such that it is configured to perform a calibration process that comprises analyzing the first image and the second image to determine a difference in a shape of the one or more locators relative to a known shape of the locators, determining an orientation of the imaging device relative to the jointed limb based on the difference in the shape of the one or more 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, because doing so prevents disorientation of a user when using medical images for medical purposes (i.e., prevents disorientation of a surgeon during surgery), and thus demonstrates the need for calibrating an imaging device such that the orientation of images obtained from it are in accordance with the plurality of locators (see Barral, par 0003-0005).
With respect to claim 34, Kang as modified by Tam and Lin teaches the method of claim 33. of Kang as modified by Tam fails to teach the calibration process comprises: 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 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.
Barral teaches a system for the display of preoperative and intraoperative images that comprises changing the orientation of preoperative images by a surgeon or a controller if it becomes more desirable to show a different angle of the preoperative image model (see Barral, par 0029 & 0035). Furthermore, the preoperative image may be changed as a result of recognition of fiducial markers in the preoperative image, wherein once the fiducial markers are recognized, the orientation of the preoperative image is changed to best display the data (i.e., the orientation of the preoperative images is updated in accordance with the fiducial markers) (see Barral, par 0041 & 0043).
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 method of Kang as modified by Tam and Lin such that it is configured to perform a calibration process that comprises 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 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, because doing so prevents disorientation of a user when using medical images for medical purposes (i.e., prevents disorientation of a surgeon during surgery), and thus demonstrates the need for calibrating an imaging device such that the orientation of images obtained from it are in accordance with the plurality of locators (see Barral, par 0003-0005).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang in view of Tam and Lin as applied to claim 1 above, 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 and Lin 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 and Lin 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 and Zamierowski teaches the system of claim 12. Kang as modified by Tam and Lin 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 and Lin 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 and Zamierowski teaches the system of claim 13. Kang as modified by Tam and Lin 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 and Lin 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./ Examiner, Art Unit 3791
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