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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/17/2023 has been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
• “first device”, and “second device” first recited in claims 1 and 11;
• “a navigation system” recited in claims 4 and 19;
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for “first device” and “second device” are identified as device 9 and device 106, comprising electronic circuitry and at least one inertial measurement unit (IMU) for measuring orientation, as described in par. [0032].
The corresponding structure for “navigation system” is identified as the first device, second device, and computer, described in par. [0065].
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10 and 16-20 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.
Regarding claim 1, the claim recites “wherein a zero level is determined by kinematic axes coupling rotational joints to the first and second segments”. Based on the current construction of the claim, it seems to recite that the kinematic axes perform the act of coupling rotational joints to the first and second segments. However, the first and second segments are segments of a musculoskeletal system of a person. Therefore it is unclear how the kinematic axes of the application included in the computer is capable of coupling the rotational joints between segments. Clarification is requested.
For the purposes of examination, the claim is interpreted as “wherein a zero level is determined by kinematic axes coupling virtual rotational joints to virtual representations of the first and second segments”.
Further regarding claim 1, the claim recites the limitation "wherein the measurement data collected during the at least one movement" in lines 11-12. There is insufficient antecedent basis for this limitation in the claim. Clarification is requested.
For the purposes of examination, the claim is interpreted as "wherein measurement data is collected during the at least one movement, wherein the measurement data collected during the at least one movement…".
Regarding claim 2, the claim recites “wherein the rotational joints comprises a first segment end coupling to a first joint that provides rotational freedom and a second segment end coupling to a second joint that provides rotational freedom,”. It is unclear whether a first segment end refers to an end of the first segment recited in claim 1, or whether the it is an end of another segment. A similar issue of unclarity is present for the recitation of a second segment end. Clarification is requested.
For the purposes of examination, “a first segment end” is interpreted as “an end of the first segment” and “a second segment end” is interpreted as “an end of the second segment”.
Further regarding claim 2, the claim recites the phrase “wherein an end of the first segment end”. It is unclear what this recitation refers to. The first segment end represents an end of the first segment, therefore it is unclear how this end may have an end. Clarification is requested.
For the purposes of examination, the phrase is interpreted as “wherein the first segment end”.
Regarding claims 4 and 19, the claims recite “further comprising a navigation system for monitoring…”. The navigation system is interpreted under 35 U.S.C. 112(f), and is interpreted as the first device, the second device, and the computer (See claim interpretation above). As these elements are recited in claim 1, it is unclear how the limitations of claim 4 further limit the limitations of claim 1, which renders the claim indefinite. A similar recitation an issue of indefiniteness is present in claim 19. Clarification is requested.
For the purposes of examination, the any reference or combination of references that meets the claim limitations of claims 1 and 11 will also meet the claim limitations of claims 4 and 19, respectively.
Regarding claim 7, the claim recites “when the at least one movement has traveled a predetermined distance or angle”. The recited at least one movement of claim 1 describes the motion of a person, wherein the first segment rotates and the second segment moves in a straight line. It is unclear, however, how the movement can travel a predetermined distance or angle. If the movement comprises motion of the segments, the segments may travel a distance or angle, but the movement refers to a pattern of motion of the segments. Clarification is requested.
For the purposes of examination, the claim is interpreted as “when the first segment or second segment has traveled a predetermined distance or angle.”
Regarding claim 17, the claim recites the limitation “the movement of the calibration process” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
For the purposes of examination, the limitation is interpreted as “the at least one movement”.
Regarding claim 16, the claim recites “wherein a zero level corresponds to a static calibration pose”. It is unclear whether “a zero level” refers to the same zero level recited in claim 1, or a different zero level. Clarification is requested.
For the purposes of examination, the claim is interpreted as “wherein the zero level corresponds to a static calibration pose”.
Regarding claim 17, the claim recites the limitation “the movement of the calibration process” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
For the purposes of examination, the limitation is interpreted as “the at least one movement”.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2022/0299542 by Ramalho Ferreira et al., hereinafter “Ramalho Ferreira” in view of US Patent Publication 2019/0090744 by Mahfouz, hereinafter “Mahfouz”.
Regarding claims 1 and 4, Ramalho Ferreira teaches a kinematics tracking system comprising: a first device configured to measure a first orientation wherein the first device is configured to be coupled to a first segment of a musculoskeletal system of a person (Fig. 2b, device 20b is coupled to the thigh of person 1. [0103]; Each IMU may include an accelerometer, gyroscope (measures orientation), and a magnetometer); a second device configured to measure a second orientation wherein the second device is configured to be coupled to a second segment of the musculoskeletal system of the person (Fig. 2b device 20c); and a computer configured to receive measurement data from the first device and the second device (Fig. 1, [0104]; computing device 15 receive data from the IMUs), wherein a zero level is determined by kinematic axes coupling rotational joints to the first and second segments (Fig. 5 shows joint 95f coupling segment 94g or 94h. Axis A can be considered a kinematic axis of a coupling rotational joint defining zero level. The angle 98 is measured relative to axis A), wherein at least one movement comprises the first segment configured to rotate and the second segment is configured to move in a straight line while remaining rotationally free (the segments of a body of a person can perform this movement), wherein the measurement data collected during the at least one movement is used to determine a rotation of δF and δT of the first device and the second device such that the zero level corresponds to a kinematic axis connecting the rotational joints with a shared joint coupled between the first and second segments ([0164-0168]; The model (containing the rotational joints and the rotations of the first and second devices) is modified according to a predetermined movement being performed for calibrating the model. The rotations of the segments, such as angle 98 correspond to a rotation δF and δT of the first device and the second device).
Ramalho Ferreira does not teach wherein the computer includes an application configured to direct the person to perform a registration process.
Mahfouz teaches a method of calibrating IMUs wherein an application directs a user to complete a series of actions to calibrate the IMUs (Figs. 5-9). The application and calibration (i.e., registration) process allows an individual user to use the motion tracking system individually and for collected data to be reviewed by a physician or therapist at a later time ([0102]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Ramalho Ferreira such that the system includes an application configured to direct the person to perform a registration process, to allow for the use of the motion tracking system individually, wherein the collected data can be reviewed by a physician or therapist at a later time, as taught by Mahfouz ([0102]).
It is noted that the navigation system of claim 4 is interpreted as comprising the first device, second device, and computer (See claim interpretation in paragraph 4 above). Therefore Ramalho Ferreira in view of Mahfouz as applied to claim 1 also teaches the limitations of claim 4.
Regarding claim 2, Ramalho Ferreira in view of Mahfouz teaches the kinematics tracking system of claim 1, wherein the rotational joints comprises a first segment end coupling to a first joint that provides rotational freedom (Ramalho Ferreira, Fig. 5, joint 95e can be considered the first joint wherein the first segment (94g) is coupled to it) and a second segment end coupling to a second joint that provides rotational freedom (Ramalho Ferreira, Fig. 5, joint 95f can be considered the second joint wherein the first segment (94g) is coupled to it), wherein an end of the first segment end is configured to have no translational movement (The first segment end of the model 91 of Ramalho Ferreira is a virtual representation of a person. A person is capable of not translating their hip joint (analogous to joint 95e) therefore not translating the first segment end), and wherein the computer is configured to receive the measurement data and calculate the rotation of δF and δT of the first device and the second device such that the zero level corresponds to the kinematic axis coupling the rotational joints with the shared joint coupled between the first and second segments (See the rejection of claim 1; the shared joint between the first and second joints is joint 95f).
Regarding claim 3, Ramalho Ferreira in view of Mahfouz teaches the kinematics tracking system of claim 1, wherein the first device includes at least one inertial measurement unit (IMU) configured to measure the first orientation, and wherein the second device includes at least one IMU configured to measure the second orientation (Ramalho Ferreira, Fig. 2b, [0103, 0110]; device 20b and 20c are IMUs comprising gyroscopes, capable of measuring orientation).
Ramalho Ferreira in view of Mahfouz does not teach wherein the first device is configured to couple to skin of the person, wherein the second device is configured to couple to the skin.
Figs. 2A and 2D of Ramalho Ferreira further teaches configurations of sensors wherein the sensors (20b and 20c of Fig. 2A and 20b of Fig. 2D) are attached to the skin of a person.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Ramalho Ferreira in view of Mahfouz such that the first device is configured to couple to skin of the person, wherein the second device is configured to couple to the skin. This modification merely comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A.
Regarding claim 6, Ramalho Ferreira in view of Mahfouz teaches the kinematics tracking system of claim 1, wherein the computer includes a display (Mahfouz, Figs. 5-9 show a display of the application for the registration process),
Ramalho Ferreira in view of Mahfouz does not teach wherein the display indicates a position of the first segment and the second segment, and wherein the display is configured to indicate movement of the first segment and the second segment in real-time.
Fig. 18-19 of Mahfouz further teaches the application updating the tracked anatomy of the user in real-time. The application includes representations of the femur and shank (tibia and fibula), corresponding to the first and second segments. This display provides dynamic visual information to the user ([0099, 0102]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system taught by Ramalho Ferreira in view of Mahfouz such that the display indicates a position of the first segment and the second segment, and wherein the display is configured to indicate movement of the first segment and the second segment in real-time, providing dynamic visual information to the user, as taught by Mahfouz ([0099, 0102]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ramalho Ferreira in view of Mahfouz, as applied to claim 1, in view of WIPO Patent Publication 2020/123988 by Khan et al., hereinafter “Khan”.
Ramalho Ferreira in view of Mahfouz teaches the kinematics tracking system of claim 1, but does not teach wherein the first device is a first implanted device configured to be coupled to the first segment, wherein the second device is a second implanted device configured to be coupled to the second segment, and wherein the first and second devices are subdermal.
Fig. 4 of Khan teaches a high precision inertial measurement sensing system wherein sensors 402 and 404 measure orientation. The sensors may be attached to the bones/and or implant of the user (i.e., subdermal) and data is wirelessly communicated to monitor 450 with a display. Using the inertial sensors during surgery improves precisions in an alignment and angular movement of the patient’s knee during the procedure and after the procedure in the clinic, without using an expensive surgical robot ([0033]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Ramalho Ferreira in view of Mahfouz such that the first device is a first implanted device configured to be coupled to the first segment, wherein the second device is a second implanted device configured to be coupled to the second segment, and wherein the first and second devices are subdermal, to improve precision in an alignment and angular movement of the patient’s knee during a procedure and after the procedure in the clinic, without using an expensive surgical robot, as taught by Khan ([0033]).
Claims 7-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ramalho Ferreira in view of Mahfouz, as applied to claims 1 and 6, in view of US Patent Publication 2018/0360383 by Ishikura et al., hereinafter “Ishikura” in view of An inertial and magnetic sensor… by O’Donovan et al. (2007), hereinafter “O’Donovan”.
Regarding claims 7 and 8, Ramalho Ferreira in view of Mahfouz teaches the kinematics tracking system of claim 6, but does not teach wherein the display includes a movement bar configured to show movement related to the second segment, wherein the at least one movement is displayed in real-time as the person performs the at least one movement, and wherein the display indicates when the at least one movement has traveled a predetermined distance or angle.
Fig. 22 of Ishikura teaches a system for the monitoring of a subject’s movement, comprising two devices (100 and 200), each comprising sensors (acceleration sensors and angular velocity sensors). The two devices are calibrated by the user moving to match a predetermined position, as indicated an application. The information indicating progress of the calibration may be presented visually as a progress bar ([0200]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Ramalho Ferreira in view of Mahfouz such that the display includes a movement bar configured to show movement related to the second segment, wherein the at least one movement is displayed in real-time as the person performs the at least one movement, and wherein the display indicates when the at least one movement has traveled a predetermined distance or angle, as the progress bar (i.e., movement bar) provides visual feedback to the user, as taught by Ishikura ([0200]).
It is noted that the calibration procedure of Ramalho Ferreira in view of Mahfouz comprises a predetermined movement for the calibration, therefore the completion of the predetermined movement must include moving a predetermined distance or angle. The combination of Ramalho Ferreira, Mahfouz, and Ishikura teaches the progress bar relating to the at least one movement. The combination of Ramalho Ferreira, Mahfouz, and Ishikura does not teach a movement bar configured to show movement related to the second segment.
O’Donovan teaches a movement for the calibration of IMUs around a knee joint as a seated knee extension task (Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the predetermined movement taught by Ramalho Ferreira, Mahfouz, and Ishikura such that the predetermined movement comprises a knee extension task as taught by O’Donovan, such that the display includes a movement bar configured to show movement related to the second segment. This combination comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A. It is noted that in the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan, the second segment is moving in the at least one movement, so the movement bar would be configured to show movement related to the second segment.
It is further noted that the movement bar corresponding to the at least one movement related to the second segment comprises a visual feedback to the at least one movement, and therefore satisfies the limitations of claim 8.
Regarding claim 9, the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan teaches the kinematics tracking system of claim 8, wherein the at least one movement comprises the person sitting in a chair and sliding a heel of a leg along a floor in a straight line or wherein the at least one movement comprises the person sitting in the chair and the person lifting the leg with a toe touching a wall (the person is capable of performing each of these movements in addition to the predetermined movement for calibration taught by the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan).
Regarding claim 10, the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan teaches the kinematics tracking system of claim 8, wherein the at least one movement comprises a back of the person coupled to a wall and sliding a heel of a leg from the wall in a straight line away from the wall, or wherein the at least one movement comprises the back of the person coupled to the wall and sliding the heel from a floor upward in a straight line along the wall (the person is capable of performing each of these movements in addition to the predetermined movement for calibration taught by the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan).
Regarding claim 11, the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan teaches a kinematics tracking system comprising: a first device configured to measure a first motion, a first position, or a first orientation wherein the first device is configured to be coupled to a first segment of a musculoskeletal system of a person (See the rejection of claim 1, the IMUs 20b and 20c comprise accelerometers, gyroscopes, and magnetometers and are therefore configured to measure position, orientation and motion (position over time)); a second device configured to measure a second motion, a second position, or a second orientation wherein the second device is configured to be coupled to a second segment of the musculoskeletal system of the person (See the rejection of claim 1); and a computer configured to receive measurement data from the first device and the second device (See the rejection of claim 1) wherein the computer includes an application configured to direct the person to perform a registration process comprising a movement (See the rejection of claim 1), wherein the first segment is configured to rotate and wherein the second segment is configured to move in a straight line while remaining rotationally free (See the rejection of claim 1), wherein the computer reports on a display when the second segment has moved a predetermined distance or angle (See the rejection of claim 7).
Regarding claim 12, the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan teaches the kinematics tracking system of claim 11, wherein the display indicates the first position of the first segment and the second position of the second segment (See the rejection of claim 6, the real-time tracking includes an initial position and orientation of the first and second segments), wherein the display is configured to indicate movement of the first segment and the second segment in real-time (See the rejection of claim 6), and wherein the kinematics tracking system is configured to provide audible, visual, or haptic feedback to the person to support the registration process (the progress bar of the calibration is visual feedback to support the registration process).
Regarding claim 15, the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan teaches the kinematics tracking system of claim 11, wherein the display further includes a movement bar configured to show movement related to the second segment in real-time, wherein the display indicates when the movement has traveled the predetermined distance (See the rejection of claim 7) such that the movement can be repeated or stopped (the user is capable of repeating or stopping the at least one movement).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ramalho Ferreira in view of Mahfouz, as applied to claim 12, in view of Lower Limb Kinematics Using Inertial Sensors… (2020) by Lebleu et al., hereinafter “Lebleu”.
The combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan teaches the kinematics tracking system of claim 12, wherein the application is configured to support the registration process using the movement (See the rejection of claims 1 and 11, the application directs the person to perform a series of acts to calibrate the IMUs), but does not teach wherein the movement comprises the person sitting in a chair sliding a heel of a leg along a floor in a straight line or wherein the movement comprises the person sitting in the chair and the person lifting the leg with a toe touching a wall.
Fig. 2 of Lebleu teaches a method of calibrating body-worn IMUs. Fig. 2b teaches a movement for a functional calibration movement (Calibration movement 2) comprising the person sitting and sliding their foot along the floor and in a straight line. Applying a functional calibration movement such as this before IMU-based lower limb kinematic assessment allows for a fairly accurate measurement of gait movements (4. Discussion, par. 1).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the movement of system taught by the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan such that the movement comprises the person sitting in a chair sliding a heel of a leg along a floor in a straight line, as applying a functional calibration movement before IMU-based lower limb kinematic assessment allows for a fairly accurate measurement of gait movements, as taught by Lebleu (4. Discussion, par. 1).
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ramalho Ferreira in view of Mahfouz, as applied to claim 1, in view of US Patent Publication 2017/0042467 by Herr et al., hereinafter “Herr”.
Regarding claims 16 and 17, Ramalho Ferreira in view of Mahfouz teaches the kinematics tracking system of claim 1, wherein the first and second segments are adjacent (the first segment and second segment are connected by a joint, therefore they must be adjacent), wherein a zero level corresponds to a static calibration pose of the first and second segments (Ramalho Ferreira, Fig. 5 depicts a static calibration pose, and the angle 98 depicts a deviation from that static calibration pose), wherein the zero level is determined by kinematic axes coupling rotational joints to the first and second segments (See the rejection of claim 1), wherein the application on the computer is configured to direct the person through the movement of the first or second segments to determine a rotation of δF and δT of the first device and the second device such that the zero level corresponds to the static calibration pose (see the rejection of claim 1), but does not teach wherein an end of the first segment is positioned to prevent movement of the end, and wherein an end of the second segment moves in a straight line.
Fig. 9 of Herr teaches a method of calibrating IMUs placed on the lower body ([0026]), by performing a calibration movement comprising standing straight up and sliding the foot along the ground (i.e., in a straight line) while maintaining the position of an end of the first segment (the end of the femur corresponding to the hip does not move).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified at least one movement taught by Ramalho Ferreira in view of Mahfouz such that an end of the first segment is positioned to prevent movement of the end, and wherein an end of the second segment moves in a straight line. This combination comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A.
It is noted that in this combination of Ramalho Ferreira, Mahfouz, and Herr, the first segment does not have translational movement during the movement of the calibration process, meeting the limitations of claim 17.
Regarding claims 18 and 19, the combination of Ramalho Ferreira, Mahfouz, and Herr teaches The kinematics tracking system of claim 17, but does not teach wherein the first device is configured to couple to skin of the person, wherein the second device is configured to couple to the skin, wherein the first device includes an inertial measurement unit (IMU) configured to measure the first orientation, and wherein the second device includes an IMU configured to measure second orientation.
Figs. 2A and 2D of Ramalho Ferreira further teaches configurations of sensors wherein the sensors (20b and 20c of Fig. 2A and 20b of Fig. 2D) are attached to the skin of a person.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of the combination of Ramalho Ferreira, Mahfouz, and Herr such that the first device is configured to couple to skin of the person, wherein the second device is configured to couple to the skin. This modification merely comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A.
It is noted that the navigation system of claim 19 is interpreted as comprising the first device, second device, and computer (See claim interpretation above). Therefore the combination of Ramalho Ferreira, Mahfouz, and Herr as applied to claim 18 also teaches the limitations of claim 19.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ramalho Ferreira in view of Mahfouz in view of Herr, as applied to claim 19, in view of Khan.
The combination of Ramalho Ferreira, Mahfouz, and Herr teaches the kinematics tracking system of claim 19, but does not teach wherein the first device is a first implanted device coupled to the first segment, wherein the second device is a second implanted device coupled to the second segment, and wherein the first and second devices are subdermal.
Fig. 4 of Khan teaches a high precision inertial measurement sensing system wherein sensors 402 and 404 measure orientation. The sensors may be attached to the bones/and or implant of the user (i.e., subdermal) and data is wirelessly communicated to monitor 450 with a display. Using the inertial sensors during surgery improves precisions in an alignment and angular movement of the patient’s knee during the procedure and after the procedure in the clinic, without using an expensive surgical robot ([0033]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of the combination of Ramalho Ferreira, Mahfouz, and Herr such that the first device is a first implanted device configured to be coupled to the first segment, wherein the second device is a second implanted device configured to be coupled to the second segment, and wherein the first and second devices are subdermal, to improve precision in an alignment and angular movement of the patient’s knee during the procedure and after the procedure in the clinic, without using an expensive surgical robot, as taught by Khan ([0033]).
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 14 recites the kinematics tracking system of claim 12, wherein the application is configured to support the registration process using the movement, wherein the movement comprises a back of the person coupled to a wall and sliding a heel of a leg from the wall in a straight line away from the wall, or wherein the movement comprises the back of the person coupled to the wall and sliding the heel from a floor upward in a straight line along the wall.
The closest prior art is identified as the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan, as applied to claim 12.
The combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan teaches the kinematics tracking system of claim 12, wherein the application is configured to support the registration process using the movement (See the rejection of claims 1 and 11, the application directs the person to perform a series of acts to calibrate the IMUs).
The prior art of the combination of Ramalho Ferreira, Mahfouz, Ishikura, and O’Donovan fails to teach wherein the movement comprises a back of the person coupled to a wall and sliding a heel of a leg from the wall in a straight line away from the wall, or wherein the movement comprises the back of the person coupled to the wall and sliding the heel from a floor upward in a straight line along the wall.
These limitations of claim 14 are patentably distinct over the prior art cited in this Office action and any other prior art.
Etsub did not make a comment here about identifying this as allowable. I reached out to a few primaries and did not get a response. I also went to the QAS shop and they gave me search strings to try but none of that came up with anything that was useful for claim 12.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2014/0303524 by Chen et al. teaches a method of calibrating a set of IMUs with a set of predetermined calibration movements with the aid of a computer.
US Patent Publication 2017/0296115 by Mahfouz teaches a motion tracking system using inertial measurement units that uses a calibration to establish a zero level corresponding to a static pose.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791