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
Claims 18, 19, 21, 24, 25, 28-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/18/26.
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 1-2, 4, 7-9, 11-17 are 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.
Independent claims 1 and 18 are ambiguous as to whether the claim positively requires the one or more motorized struts. For example, in claim 1, line 2, the frame is configured to support the strut(s), which introduces the strut(s) in a functional/intended use capacity. However, in line 6-7, the processing component(s) are coupled to a strut/motor which would require the strut/motor. There is never a clear limitation that positively incorporates the motorized strut(s) as part of the spatial frame apparatus and therefore the scope is ambiguous. As best understood, for examination purposes, claim 1, line 2 will be interpreted as “a frame supporting one or more motorized struts…” which positively requires the one or more motorized struts. Claim 18, line 4 has the same issue as described in claim 1 and will be interpreted the same way for examination purposes- positively requiring the one or more motorized struts.
Dependent claims 2, 4, 7-9, 11-17, 19, 21, 24-25, 28-34 are rejected under 112(b) as they contain all the deficiencies of claim 1 or 18 from which they depend.
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.
Claim(s) 1 (as best understood)-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferrante et al. (WIPO WO2021/061816 A1).
Regarding Claim 1, Ferrante discloses a spatial frame apparatus (1000, Fig. 9), comprising:
a frame (1010, 1020) configured to support one or more motorized struts (fig. 20, item 1160) (for the combination of the strut 1160 of fig. 20 with the frame 1000 of fig. 9, please refer to para. [0205]. 1st sentence), wherein the one or more motorized struts (1160) comprise one or more motors (1165) configured to cause movement of the one or more motorized struts in one or more directions in accordance with one or more treatment plans (para. [00204], 3rd sentence);
one or more processing components (1200) communicatively coupled to at least one of: the one or more motorized struts and the one or more motors (para. [00204], 3rd sentence);
wherein the one or more processing components (1200) are configured to determine one or more loading parameters on the one or more motorized struts (“all three forces and three moments in the strut 1160”, [00194]);
wherein the one or more loading parameters define loading on the one or more motorized struts upon the frame being at least one of: positioned on a patient and adjusted on the patient (para. [00194]); and
wherein the one or more processing components (1200) execute at least one adjustment in one or more adjustments of the one or more motorized struts based on the one or more loading parameters (para. [00194], “The sensor data can be used in a controlled feedback loop to independently actuate the wireless automated struts 1160 by controlling the force or extension/compression of the frame.”).
Regarding Claim 2, further comprising one or more monitoring components selected from one of the following: one or more sensors, one or more gauges, and any combination thereof, the one or more monitoring components configured to perform monitoring of at least one of the following: loading on the one or more motorized struts, current pull by the one or more motors from one or more power sources communicatively coupled to the one or more motors, and any combination thereof ([00200] describes current sensor).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrante et al. (WIPO WO2021/061816 A1) in view of Hyung Jung et al. (US Publication No. 2020/0306584 A1),
Regarding Claim 4, Ferrante discloses that the forces in all three directions on the strut are measured and the data can be used in a controlled feedback loop to actuate the struts by controlling the force of the frame [0194], however Ferrante doesn’t expressly describe any “baseline loading” measurement taken upon an action performed by the patient while the frame is on the patient.
Hyung Jung discloses a calibration phase in the analogous art of limb rehabilitation devices with load cells, wherein there is an initial baseline measurement taken upon the installation of the device on the patient in a calibration phase (1000) in order to see if subsequent loads applied by the device are in the positive force or negative force [0092]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to establish a baseline load measurement during a calibration phase as taught by Hyung Jung when the device is first installed on the patient in order to accurately measure subsequent forces on the device.
Claim(s) 7-9, 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrante et al. (WIPO WO2021/061816 A1) in view of Cordonnier et al. (US Publication No. 2022/0409140 A1).
Regarding Claim 7, Ferrante discloses that the forces in all three directions on the strut are measured and the data can be used in a controlled feedback loop to independently actuate the struts by controlling the force of the frame [0194]. This occurs while the frame is attached to the patient. However Ferrante doesn’t expressly describe any loading thresholds which are defined and which initiate an actuation (adjustment) if exceeded.
Cordonnier discloses, in the analogous art of automated loading processes of a medical device, independent actuation is done by establishing loading thresholds which, when reached, initiate an adjustment action of the lengthening of the implant device in order to adjust the loading to the desired amount [0216]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to build the controlled feedback loop through establishing thresholds of sensor data and initiating adjustments when the thresholds are reached as taught by Cordonnier in order to adjust the force (loading) of the frame to desired levels.
Regarding Claim 8, Ferrente discloses that the struts have wireless communication modules [0030-0031, 0204, 0191] and further, the above modification of the loading thresholds being used to initiate the adjustment inherently requires the use of communication components to send the signals to the motorized struts to cause actuation.
Regarding Claim 9, Ferrente discloses adjustments are performed by actuation of the struts [0194]. The actuation of the struts are defined by at least one of the following: a direction of the one or more adjustments of the one or more motorized struts, a length of the one or more adjustments of the one or more motorized struts, an angle of the one or more adjustments of the one or more motorized struts, a time for the one or more adjustments of the one or more motorized struts, a change in positioning of the one or more motorized struts, and any combination thereof [00113, 00162, 00204, Ferrente].
Regarding Claim 11, Ferrante discloses that the forces in all three directions on the strut are measured and the data can be used in a controlled feedback loop to independently actuate the struts by controlling the force of the frame [0194]. Ferrante discloses that the computing system/device which communicates with the struts has software which stores and communicates treatment plan information [00157-0162], however Ferrante doesn’t expressly describe one or more machine-learning components, the one or more machine-learning components determine an expected healing time associated with a treatment of an injury to the patient.
Cordonnier discloses, in the analogous art of automated patient-specific adjustable implants, use of a server communicating with the implant, configured to generate patient-specific treatment plan data which can predict outcomes including recovery times [0062]. The predictive model(s) can be developed using clinical knowledge, statistics, machine learning, AI, neural networks, or the like [0068].
It would have been obvious to one having ordinary skill in the art to run AI-generated prediction outcomes on the computing system of Ferrante to determine expected healing time as taught by Cordonnier in order to anticipate the length of treatment for the patient as part of the treatment plan information.
Regarding Claim 12, Cordonnier machine-learning models used in generating predictions are trained using at least one of the following: one or more historic motor loading data associated with a healing process of injuries, one or more patient specific factors, an age of the patient, a weight of the patient, a bone density of the patient, an anatomical correction area of the patient, a deformity of the patient, a patient's trauma, one or more comorbidities of the patient, and any combination thereof ([0070-0075], “the training data set can include any of the reference data stored in database 110, such as multiple reference patient data sets or a selected subset thereof (e.g., multiple similar patient data sets)., “Patient data sets” are described in [0064] to include parameters such as age, gender, BMI, LL, PI, and/or treatment levels). It would have been obvious to input reference patient data sets which include information such as age, gender, BMI, LL, PI, and/or treatment levels as taught by Cordonnier in order to use pertinent information to calculate predictions on treatment parameters.
Regarding Claim 13, as discussed in the rejection of claim 11, the algorithm taught by Cordonnier (AI model) predicts a recovery time [0062]. Recovery time is a time for completion of the healing process. Considering that the device of Ferrante is an external fixator intended to be removed after healing is complete, it would be obvious to consider the end of the healing process to coincide with the removal of the frame from the patient.
Regarding Claims 14 and 15, Ferrante discloses that the struts are automated and controlled by the treatment plan and the rate of adjustment and frequency of adjustment can be controlled by this treatment plan [0023]. However, Ferrante does not describe a machine learning model being used to generate the treatment plan or predict future adjustment parameters.
Cordonnier discloses the use of a server communicating with the implant, configured to generate patient-specific treatment plan data [0062]. The predictive model(s) can be developed using clinical knowledge, statistics, machine learning, AI, neural networks, or the like [0068]. The treatment plan module generates a prescriptive model [0068-0075]. It would have been obvious to one having ordinary skill in the art to use AI algorithms and models as taught by Cordonnier to predict and generate treatment plan data and a prescriptive model in order to treat the patient with statistically the best possible outcome.
Allowable Subject Matter
Claims 16-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773
