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
The inventions of claims 1 - 16, which encompass a method directed towards assessing socket fit and claims 17 - 20, which encompass a method of calculating muscle movement, are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed do not overlap in scope and have a materially different mode of operation because one method is used to assess a socket fit for a prosthetic device using a sensor network within a socket and the other method is used to measure muscle movement with a sensor assembly in contact with a user. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions have acquired a separate status in the art in view of their different classification. Specifically, claims 1 - 16 are classified in USPC A61F 2/76 (Means for assembling, fitting, or testing prosthesis) and Claims 17 - 20 are classified in USPC A61B5/68 (arrangements of detecting, measuring, or recording means, e.g., sensors in relation to patient).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Attorney Tom Cowan on 1/03/2026, a provisional election was made without traverse to prosecute the invention of a method for assessing socket fit, claims 1 - 16. Affirmation of this election must be made by applicant in replying to this Office action. Claims 17 - 20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regard to claim 12, lines 1 - 2 recite, “The method of Claim 9, wherein the muscle movement comprises muscle deformation.” However, under BRI, “muscle deformation” encompasses “volume changes of the limb,” which is introduced in claim 9 from which claim 12 depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 - 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hurley (US 20180020973 A1 - cited by Applicant)
In regard to claim 1, Hurley discloses A method of assessing socket fit, comprising:
obtaining a measurement related to muscle movement utilizing or derived from a sensor assembly positioned within a socket worn by a user, wherein the sensor assembly measures a signal caused by a force applied by the user’s limb against the sensor assembly; Hurley discloses a method for profiling a distribution of forces transferred from the body weight and residual limb of a wearer of a prosthetic socket (FIG. 5A, component 100) to the socket using a sensor assembly (paragraph [0010]; FIG. 5A, components 51). The sensor assembly may include different types of sensors to detect and quantify force, torque, load, and/or pressure in many different ways and can further include other types of sensors including motion sensors, magnetic field sensors, global positioning sensors (paragraph [0091]).
determining if the measurement related to muscle movement satisfies a force or displacement threshold corresponding to a desired fit of the limb within the socket; Hurley discloses that their method includes using measured sensor data from the force sensors to determine the amount of pressure inside of specific regions of the socket and compare the pressure to a maximum threshold based on qualitative data collected from the user on comfort scores and daily use metrics (paragraph [0098]). As noted in paragraph [0008] of Applicant’s specification, “Pressure may, alternatively or in addition to force, be used as described with respect to an applied force or a force sensor. Thus, any description herein of the use of “force” applies equally to pressure unless otherwise indicated,” thus the pressure threshold disclosed by Hurley meets the claim limitation set forth in claim 1.
outputting an indication regarding the fit of the limb within the socket. Hurley discloses that the measured data is used to produce notifications to a user, such as a notification sent directly to a user’s smart device with recommendations for socket adjustment (paragraph [0098]). Hurley further discloses that notifications, alerts, alarms, or instructions can be associated with any sensor (e.g., pressure, tension, moisture, temperature), with a range of values defined as normal and a range (or upper and/or lower limits, for example) defined as concerning (paragraph [0113]).
In regard to claim 2, Hurley discloses the invention as set forth for claim 1, further comprising determining if the measurement related to muscle movement exceeds a minimum force or displacement corresponding to a desired amount of pressure between the limb and the socket. Hurley discloses that their method includes using measured sensor data from the force sensors to determine the amount of pressure inside of specific regions of the socket and compare the pressure to a maximum threshold based on qualitative data collected from the user on comfort scores and daily use metrics (paragraph [0098]) and further discloses further discloses that measurements associated with any sensor (e.g., pressure, tension, moisture, temperature) can be sorted into a range of values defined as normal and a range (or upper and/or lower limits, for example) defined as concerning (paragraph [0113]).
In regard to claim 3, Hurley discloses the invention as set forth for claim 2, further comprising determining if the measurement related to muscle movement is below a maximum force or displacement corresponding to a desired range of motion. Hurley discloses that their method includes using measured sensor data from the force sensors to determine the amount of pressure inside of specific regions of the socket and compare the pressure to a maximum threshold based on qualitative data collected from the user and further discloses that the collected qualitative data includes information on reduced and increased range of motion (paragraph [0145]).
In regard to claim 4, Hurley discloses the invention as set forth for claim 1, wherein the sensor assembly comprises an EMG sensor and a) a force sensor or b) a displacement sensor. Hurley discloses that the sensor assembly may include one or more sensors within the socket for sensing various parameters, including force and motion sensors in addition to sensors configured to measure electromyographic (EMG) signals (paragraph [0087]).
In regard to claim 5, Hurley discloses the invention as set forth for claim 1, wherein the sensor assembly is calibrated to a plurality of force values for a corresponding plurality of measurements related to muscle movement. Hurley discloses that the data collected from the plurality of sensors (FIG. 11), including using EMG sensors (paragraph [0087]) configured to measure muscle movement, is uploaded to a computer application (FIG. 11, component 344) that includes a movement analysis module (FIG. 11, component 360) that tracks movement of the user (FIG. 11, component 366; paragraph [0201]).
In regard to claim 6, Hurley discloses the invention as set forth for claim 1, wherein the determination of the measurement related to muscle movement satisfies the force or displacement threshold is performed using a processor of a mobile device. Hurley discloses that a processor is used to analyze the sensor data and determine if the pressure in the socket is beyond the maximum threshold based on qualitative data (paragraph [0098]).
In regard to claim 7, Hurley discloses the invention as set forth for claim 6, further comprising providing instructions to the mobile device display to increase or decrease a socket size based on the determination of if the measurement related to muscle movement satisfies the force or displacement threshold. Hurley discloses that based on the determination that the measured pressure is beyond a threshold value, a notification is sent to a user’s mobile device, in this case a smart phone, to provide a recommendation on how to adjust the socket (paragraph [0098]), where the adjustment can include changing the size of the socket by engaging a bladder system (FIG. 25, component 710; paragraphs [0238] - [0240]).
In regard to claim 8, Hurley discloses the invention as set forth for claim 1, comprising obtaining a plurality of measurements related to muscle movement over a period of time to measure volume changes of the limb within the socket and outputting an indication regarding volume changes of the limb. Hurley discloses that their method includes monitoring a user over time and establishing a user baseline and targets associated with the socket, collecting data over time using the prosthetic socket sensor assembly, and analyzing the data at regular time intervals where machine learning principles and predictive algorithms are utilized to provide notifications and information to a user or associated person, such as a healthcare professional, researcher, or family member (paragraph [0166]). Hurley further discloses that pressure in the socket, tightness of the socket, and overall volume of the residual limb may be tracked and that notifications, alerts, alarms, or instructions can be associated with the measured sensor data (paragraph [0113]). Hurley additionally discloses that changes in inductance may be used to track changes in circumference of the residual limb, and circumferences throughout the residual limb may be used to mathematically estimate the overall volume of the residual limb (paragraph [0113]).
In regard to claim 9, Hurley discloses a method of assessing socket fit, comprising:
obtaining measurements related to muscle movement over a period of time utilizing or derived from a sensor assembly positioned within a socket worn by a user. Hurley discloses a method that includes measuring a variety of parameters, including pressure applied to a socket, volume of a limb, and other vital signs such as those measured by EMG sensors and accelerometers (paragraphs [0091], [0092]], [0113]). Hurley further discloses that the sensor assembly may include different types of sensors to detect and quantify force, torque, load, and/or pressure in many different ways and can further include other types of sensors including motion sensors, magnetic field sensors, global positioning sensors (paragraph [0091]).
wherein the sensor assembly measures a signal caused by varying forces applied by the user’s limb due to volume changes in the limb. Hurley discloses that pressure in the socket, tightness of the socket, and overall volume of the residual limb may be tracked and that notifications, alerts, alarms, or instructions can be associated with the measured sensor data (paragraph [0113]). Examiner notes that as written, the claim limitations only require that the sensor assembly be able to measure a signal caused by varying forces, as regardless of what causes the forces to be impacted, such as movement or volume change of the limb, the sensor assembly would still be able to measure the signal.
In regard to claim 10, Hurley discloses the invention as set forth for claim 9, further comprising determining if the obtained measurements related to muscle movement satisfy a force or displacement threshold corresponding to a desired fit of the limb within the socket. Hurley discloses that their method includes using measured sensor data from the force sensors to determine the amount of pressure inside of specific regions of the socket and compare the pressure to a maximum threshold based on qualitative data collected from the user on comfort scores and daily use metrics (paragraph [0098]) and further discloses further discloses that measurements associated with any sensor (e.g., pressure, tension, moisture, temperature) can be sorted into a range of values defined as normal and a range (or upper and/or lower limits, for example) defined as concerning (paragraph [0113]).
In regard to claim 11, Hurley discloses the invention as set forth for claim 9, further comprising outputting an indication regarding the fit of the limb within the socket. Hurley discloses that the measured data is used to produce notifications to a user, such as a notification sent directly to a user’s smart device with recommendations for socket adjustment (paragraph [0098]). Hurley further discloses that notifications, alerts, alarms, or instructions can be associated with any sensor (e.g., pressure, tension, moisture, temperature), with a range of values defined as normal and a range (or upper and/or lower limits, for example) defined as concerning (paragraph [0113]).
In regard to claim 12, Hurley discloses the invention as set forth for claim 9, wherein the muscle movement comprises muscle deformation. Examiner notes that as written, muscle deformation is broad and under BRI could encompass any process of the muscle changing in shape including changes to the muscle volume. Hurley discloses that pressure in the socket, tightness of the socket, and overall volume of the residual limb is measured (paragraph [0113]). Hurley additionally discloses that changes in inductance may be used to determine changes in circumference of the residual limb, and circumferences throughout the residual limb may be used to mathematically estimate the overall volume of the residual limb (paragraph [0113]).
In regard to claim 13, Hurley discloses the invention as set forth for claim 9, further comprising quantifying volume changes of the limb over the period of time based on the obtained measurements related to muscle movement. Hurley discloses that pressure in the socket, tightness of the socket, and overall volume of the residual limb is measured (paragraph [0113]). Hurley additionally discloses that changes in inductance may be used to determine changes in circumference of the residual limb, and circumferences throughout the residual limb may be used to mathematically estimate the overall volume of the residual limb (paragraph [0113]).
In regard to claim 14, Hurley discloses the invention as set forth for claim 13, wherein the period of time is at least one month. Hurley discloses that assessment of changing residual limb volume can take place over a time period of weeks or months (paragraph [0122]).
In regard to claim 15, Hurley discloses the invention as set forth for claim 9, wherein the sensor assembly comprises an EMG sensor and a) a force sensor or b) a displacement sensor. Hurley discloses that the sensor assembly may include one or more sensors within the socket for sensing various parameters, including force and motion sensors in addition to sensors configured to measure electromyographic (EMG) signals (paragraph [0087]).
In regard to claim 16, Hurley discloses the invention as set forth for claim 9, wherein the sensor assembly comprises a force sensor and is calibrated to derive a pressure signal from a measurement of the force sensor. Hurley discloses that force sensors disposed within the socket can sense outward pressure from the residual limb that is directed towards the inner structure of the socket (paragraph [0102]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hurley 2015 (US 20150313730 A1) discloses methods for making modular prosthetic sockets where a prosthetic sock that is worn within a socket includes sensors used to measure data that is utilized to adjust the socket (paragraph [0055]; paragraph [0154]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791