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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 05/04/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Element 110 in Fig. 7 is not referenced in the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 recites “the bone density” in line 4, but instead should be --a bone density--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 4, and 10 recite “the procedure” in line 6, but is indefinite. Is the procedure referring to the medical treatment plan, and/or pre/intra/post operative information? Further clarification required.
Claim 5 recites “a valgus-valgus constrained implant” in line 3, but is indefinite. What is a valgus-valgus implant? Is the implant instead a varus-valgus implant? Further clarification required.
Claim 7 recites “the joint” in lines 2-3, but is indefinite. What joint is being referred to the first, second, or both. For examination purposes, any of those interpretations are reasonable. Further clarification required.
Claims not listed are rejected by virtue of claim dependency.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mckinnon et al. (US 20200275976- cited by Applicant), hereinafter Mckinnon.
Regarding claim 1, Mckinnon teaches method for optimizing a medical treatment plan (abstract, optimizing knee arthroplasty surgical procedure), the method comprising:
receiving kinematics data from a wearable sensor coupled to an instant patient (¶[0209-10], “the Patient 805 may have a mobile phone, wearable device, or other mobile device that collects data” and “gait or biomechanical information”);
determining, based on the received kinematics data and stored information, a medical treatment plan for the instant patient (¶[0205], “optimization may be extended to the entire episode of care using an Operative Patient Care System 820 that uses the surgical data, and other data from the Patient 805 and Healthcare Professionals 830 to optimize outcomes and patient satisfaction”); and
displaying the medical treatment plan on an electronic display, wherein: the procedure includes installation of an implant (¶[0134], “The display 125 can provide the surgeon 111 with a variety of data and information about the patient, the planned surgical intervention, and the implants”), determining the medical treatment plan includes determining an alignment, position, design, or type of the implant (¶[0193,0198], a variety of implant parameters are considered for determining the treatment plant), and the stored information includes:
preoperative information for the instant patient (¶[0226], “data 810 is captured relating to the current patient 805 and is compared to all or portions of a historical database of patient data and associated outcomes” and “the system utilizes preoperative, intraoperative, or postoperative modules”), and
preoperative information, intraoperative information, and postoperative information from a plurality of previous patients having at least one characteristic in common with the instant patient (¶[0226], “Data in the historical database can be filtered to include, for example, only data sets with favorable outcomes, data sets corresponding to historical surgeries of patients with profiles that are the same or similar to the current patient profile” and “the system utilizes preoperative, intraoperative, or postoperative modules”)
each of the preoperative information, intraoperative information, and postoperative information including kinematics data obtained using a previous wearable sensor (¶[0209], “the Patient 805 may have a mobile phone, wearable device, or other mobile device that collects data”).
Regarding claim 2, Mckinnon teaches wherein the kinematics data includes: a range of motion, stiffness, or laxity of a first joint (¶[0143,0209,0317,0328], “the patient may be outfitted with one or more wearable devices that collect data relevant to the surgery,” “Patient 805 may have a mobile phone, wearable device, or other mobile device that collects data,” and “specific information from the patient, such as height, weight, age, gender, bone segment lengths, range of motion and stiffness profile for each joint, balance, posture, prior surgeries, lifestyle expectations”);
and a range of motion, stiffness, or laxity of a second joint, wherein the implant is installed at the first joint (¶[0328], “specific information from the patient, such as height, weight, age, gender, bone segment lengths, range of motion and stiffness profile for each joint, balance, posture, prior surgeries, lifestyle expectations” (emphasis added) indicating more than one joint).
Regarding claim 3, Mckinnon teaches further comprising determining that
the laxity of the second joint is less than a predetermined laxity for the second joint (¶[0134,0379], “relevant information about the knee joint such as data about the joint's tension (e.g., ligament laxity) and information concerning rotation and alignment of the joint” and “the laxity of the quadricep in the patient's passive knee and move/rotate the patella dome to add a desired amount of tension to the quadriceps while keeping the q-angle within a desired range.” One of ordinary skill in the art understands that the laxity of the knee joint is being determined by adding tension from moving the patella to be within a desired amount, i.e. above and below a range),
wherein determining the medical treatment plan includes determining whether the implant has a fit which is tighter than a predetermined fit based on the determined laxity of the second joint (¶[0379], once the implant is placed in the knee, this is the predetermined fit, when the surgeon moves the patella to achieve the desired laxity, is considered the tighter fit).
Regarding claim 4, Mckinnon teaches wherein determining the medical treatment plan includes at least determining whether: a slope of a bone to which the implant is to be aligned is to be less than a predetermined slope (¶[0190] and Fig. 5E, the tibial posterior slope is to be with 9 degrees posterior slope to 3 degree’s anterior slope).
Regarding claim 5, wherein the first joint is a knee joint, the second joint is a pelvic joint or hip joint (¶[0069,0097,0328], knee, hip, pelvic joints are arthroplasties. “[S]pecific information from the patient, such as height, weight, age, gender, bone segment lengths, range of motion and stiffness profile for each joint.”), and determining the surgical plan includes: determining that the implant is to be a valgus-valgus constrained (VVC) implant (¶[0317], total hip arthroplasty implant can be determine to be “neutral, hooded, anteverted, ceramic, constrained”), and determining whether the implant is to be aligned with a tibial slope less than or equal to a predetermined tibial slope (¶[0166-7,0174,0190] and fig. 5E, “implant alignment and positioning parameters that may be used in the knee predictor equation. . . . example parameters include . . . , the tibial posterior slope,” which must be within the 9 degrees posterior slope and 3 degrees anterior slope).
Regarding claim 16, McKinnon teaches determining, based on the received kinematics data and stored information, a rehabilitation plan for the instant patient (¶[0199], “generate a recommended post-operative rehabilitation protocol (e.g., goals, exercises, etc.). Examples of data that can affect the rehab protocol include, without limitation, implant make and size, operative time, tourniquet time, tissue release, and the intraoperative flexion” (emphasis added)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon, as applied to claim 1, and further view of Roche (US 20210290063- cited by Applicant).
Regarding claim 6, Mckinnon teaches wherein the kinematic data includes a range of motion or stiffness of a first joint (¶[0143,0209,0317,0328], “the patient may be outfitted with one or more wearable devices that collect data relevant to the surgery,” “Patient 805 may have a mobile phone, wearable device, or other mobile device that collects data,” and “specific information from the patient, such as height, weight, age, gender, bone segment lengths, range of motion and stiffness profile for each joint, balance, posture, prior surgeries, lifestyle expectations”), but fail to teach receiving a bone density of a bone adjacent to the first joint.
Roche teaches a method for detecting biometric parameters for performing bone graft surgery on the user (abstract). The method further comprises using a wearable device to measure bone density of adjacent to the joint to aid in correct installation of an orthopedic device (¶[0177], “sensors 802 can measure one or more of at least the following characteristics: load; weight; strain; pressure; wear; position; acceleration; temperature; vibration; density . . . to aid in correct installation of an orthopedic device”).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of McKinnon, such that a bone density of a bone adjacent to the first joint is received, as taught by Roche, to aid in correct installation of an orthopedic device.
Regarding claim 7, McKinnon teaches determining whether the laxity of the joint is above a predetermined laxity threshold (¶[0134,0379], “relevant information about the knee joint such as data about the joint's tension (e.g., ligament laxity) and information concerning rotation and alignment of the joint” and “the laxity of the quadricep in the patient's passive knee and move/rotate the patella dome to add a desired amount of tension to the quadriceps while keeping the q-angle within a desired range.” One of ordinary skill in the art understands that the laxity of the knee joint is being determined by adding tension from moving the patella to be within a desired amount, i.e. above and below a range); and
wherein determining the medical treatment plan includes determining whether the implant has a fit which is tighter than a predetermined fit (¶[0379], once the implant is placed in the knee, this is the predetermined fit, when the surgeon moves the patella to achieve the desired laxity, is considered the tighter fit). McKinnon fails to teach determining whether the bone density is less than a predetermined bone density threshold.
Roche teaches that a baseline reading of density is determined before monitoring the changes in the density over time (¶[0182], when below the predetermined baseline, it indicates that the bone is not healing).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of McKinnon, such that bone density less than a predetermined bone density threshold is determined, as taught by Roche, to aid in determine the surgical site is healing or not (¶[0182] of Roche).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon, as applied to claim 1, and further view of Galarneau et al. (US 20210290063), hereinafter Galarneau.
Regarding claim 8, McKinnon fails to teach wherein the kinematics data
includes: postural sway or stability data of the instant patient, a number or frequency of bending motions, squat motions, lunge motions, sit-to-stand motions, or one-legged motions performed by the instant patient over a period greater than one day, and/or includes a number of fall events of the instant patient.
Galarneau teaches an implantable medical device for monitoring the patient and to deliver therapy, including monitoring fall events (abstract and ¶[0004,0031]). The device is configured to determine the number of fall events of the patient (¶0031,0105]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of McKinnon, such that a number of fall events of the instant patient is determined, as taught by Galarneau, to aid in managing the treatment plan of a medical condition and/or indicating worsening health (¶[0003,0104] of Roche).
Regarding claim 9, McKinnon fails to teach a fall risk score based on kinematics data, wherein determining the medical treatment plan is based on the fall risk score.
Galarneau teaches an implantable medical device for monitoring the patient and to deliver therapy, including monitoring fall events (abstract and ¶[0004,0031]). The device is configured to determine the number of fall events of the patient (¶0031,0105]). The device determines that a change in the treatment management/therapy plan is required when the fall risk score (severity score, fall detection criteria, and/or posture threshold) is above a predetermined threshold (¶[0036, 0051,0066,0104], “adjusting a therapy delivered by therapy delivery circuit” and “managing treatment of a medical condition”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of McKinnon, such that a fall risk score based on kinematics data is determined, and the medical treatment plan is based on the fall risk score, as taught by Galarneau, to aid in prevent undiagnosed medical conditions or worsening of medical conditions by updated the treatment/therapy plan (¶[0003,0040-2,0051] of Roche).
Regarding claim 10, Galarneau teaches determining the fall risk score is greater than a predetermined fall risk threshold (¶[0036, 0051,0066,0104], “The medical device may set various thresholds for detecting a body posture change and an accelerometer signal spike”), and McKinnon teaches wherein determining the medical treatment plan includes determining that:
the implant is be a constrained type of implant (¶[0317], constrained implant for at least total hip arthroplasty).
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over McKinnon, as applied to claim 1, and further view of Hladio et al. (US 20230285080), hereinafter Hladio.
Regarding claim 11, McKinnon fails to teach determining, based on the received kinematics data and stored information, a prehabilitation plan for the instant patient.
Hladio teaches procedure planning based on a prehabilitation (prehab) plan (abstract and ¶[0003], “ Prehabilitation in the context of surgery (for example, total joint arthroplasty (TJA)) is the concept of preparation to optimize a patient's physical condition for a surgical procedure and its recovery”). The method include obtaining sensor measurements from sensor 104 to a prehabilitation module 10 (¶[0018-21]). The method includes receiving the user’s kinematics, based on the prehab plan, and outputs a post-surgery plan (¶[0007]). In addition, prehab metrics are obtained to determine how well the patient is complying with the prescribed prehab plan (¶[0026,0054-55], the prehab plan being based on the kinematics of the user. “The patient has a low probability of rehabilitation compliance, 2. The patient has low range of motion in their left knee, and 3. The weight loss goals of prehabilitation were not achieved” and “The advantage of allowing a user (such as a surgeon) to view surgical plans associated with different patient conditions is to provide insight, for example, into the utility of the surgical planning system 114 or into how effective the prehabilitation regime has been for the patient” indicating that the prehab plan and the metrics obtained, kinematics, are correlated to the post-surgical outcome).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of McKinnon, such that a prehabilitation plan for the instant patient is determined, based on the received kinematics data and stored information, as taught by Hladio, to aid in optimizing a patient’s physical condition for a surgical procedure and its recovery. It is further noted, McKinnon teaches using prehab data for optimizing a surgical plan, but fails to provide details, and Hladio teaches the type and plan of prehab (¶[0211]).
Regarding claim 12, McKinnon-Hladio teaches wherein receiving the kinematics data includes receiving additional kinematics data from a performance of the prehabilitation plan (¶[0211] of McKinnon, “Patient Data 815 can include, but is not limited to, activity level, preexisting conditions, comorbidities, prehab performance” (emphasis added)).
Regarding claim 13, Hladio teaches wherein determining the prehabilitation plan includes determining, based on the additional kinematics data from the performance of the prehabilitation plan, a secondary prehabilitation plan (¶[0003,0071, 0081], “Prehabilitation in the context of surgery (for example, total joint arthroplasty (TJA)) is the concept of preparation to optimize a patient's physical condition for a surgical procedure and its recovery,” “a surgical plan optimized for the post-surgical kinetic condition of the patient,” “the surgical plan based on the post-surgical rehabilitation compliance metric,” and “the surgical plan includes additional patient preparation for surgery, including one or more of: additional prehabilitation.” That is based, on the surgical plan, which includes kinematics, progression of the patient, and post-surgical outcome, additional prehabilitation plans may be required to get the patient ready for the post-surgical goals).
Regarding claim 14, McKinnon-Hladio teaches wherein determining the medical treatment plan includes determining, based on the additional kinematics data, a secondary medical treatment plan (¶[0008,0164,0312,0009] of McKinnon, the surgical plan is updated based on new information being available, the information which may include kinematics/prehab performance).
Regarding claim 15, McKinnon fails to teach determining, based on the received kinematics data, a patient readiness score; and determining, based on the patient readiness score, (i) a timing of performing the medical treatment plan, (ii) a timing of performing a prehabilitation plan, and/or (iii) a timing of performing a rehabilitation plan.
Hladio teaches determining a patient readiness score, based on kinematics data during prehab, that indicates whether the patient is complying with the plan and will continue to comply post-surgery and therefore plan a surgery date accordingly (¶[0026,0043], “extrapolation results of a post-surgical condition are useful to determine a date (e.g. a time range) for surgery”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of McKinnon, such that a patient readiness score is determined based on the kinematics data to determine a timing of performing the medical treatment plan, as taught by Hladio, to optimize a patient's physical condition for a surgical procedure and its recovery (¶[0003] of Hladio).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over McKinnon, as applied to claim 1, and further view of Rho et al. (US 20230397964), hereinafter Rho.
Regarding claim 17, McKinnon teaches receiving additional data during a performance of the medical treatment plan (¶[0160,0201,0225], “the CASS 100 can recommend any aspect of the surgical plan and modify this recommendation based on new data collected during surgery.” Additional parameters, e.g. implant size, are monitored intra-operatively and the surgical plan is updated based on the parameters), but fails to teach wherein: the implant includes one or more sensors, and at least some of the additional data is received from the implant.
Rho teaches a smart implant for hip, knee, joint, etc. arthroplasties (abstract and ¶[0005,0009,0010], smart implants aid in ensuring correct operation of the implant, improving surgical procedure, and improving the placement of the implant).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of McKinnon, such that the implant includes one or more sensors, and at least some of the additional data is received from the implant, as taught by Rho, to aid in ensuring correct operation of the implant, improving surgical procedure, and improving the placement of the implant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kraal teaches assessments of potential complications for particular patients, recommended interventions (pre-surgical or surgical) for particular patients, recommended surgical approaches and techniques for patients (including intraoperative recommendations based on additional data collected during surgery), chances of post-operative success, recommended post-intervention treatment and therapy plans, risks of failure to comply with prescribed pre- and post-operative therapy regimens (e.g., predicted poor adherence by a particular patient). US 20220223255
Jaramaz teaches a broach tracking option using femoral arrays to allow the surgeon to intraoperatively capture the broach position and orientation and calculate hip length and offset values for the patient. Based on information provided about the patient’s hip joint and the planned implant position and orientation after broach tracking is completed, the surgeon can make modifications or adjustments to the surgical plan. US 20230346478
Trabish teaches sensored measurement components are designed to allow ligaments, tissue, and bone to be in place while the quantitative measurement data is taken. This is significant because the bone cuts take into account the kinetic forces where a kinematic assessment and subsequent bone cuts could be substantial changed from an alignment, load, and position of load once the joint is reassembled. US 20190290253
Lang teaches an implant component can be placed using two or more parameters, e.g. mechanical axis alignment or modifications thereof, rotation or rotation axis, slope, femoral offset, femoral component flexion, notching, medial and/or lateral joint line, alignment relative to one or more articular surface(s) (e.g. tangent or intersecting), e.g. a medial or latera femoral condyle. US 20220133484
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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