DETAILED ACTION
This is the first Office Action on the merits and is responsive to the papers filed on 03/02/2026. Claims 1-21 are currently pending and are examined below.
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 without traverse of group 1, claims 1-11, and 21 in the reply filed on 03/02/2026 is acknowledged.
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 1-11, and 21 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.
The terms “approximately aligned” in claim 1 are relative terms which renders the claim indefinite. The terms “approximately aligned” are not defined by the claim, and the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification does discuss the that the terminology of “approximately” would mean less than or equal to 10% (see specification at page 12, lines 5-10), such a definition does not make sense with the term “aligned.” It is unclear how the base assembly would be approximately aligned with the gimbal assembly. Claims 2-11 depend from claim 1 and are therefore rejected to on the same grounds.
Claim 1 recites the limitation "the base" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “a pelvis” in line 2 of the claim. It is unclear if this is a different element than the “a pelvis” recited in line 22 of independent claim 1. Claim 9 depends from claim 8 and is therefore rejected to on the same grounds.
Claim 8 recites the limitation "the acetabulum" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claim 8 and is therefore rejected to on the same grounds.
Claim 8 recites the limitation "the pubic symphysis" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claim 8 and is therefore rejected to on the same grounds.
Claim 21 recites the limitation "the base" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
The term “approximately” in claim 21 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how the base assembly would be approximately aligned with the gimbal assembly.
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 1-3, 5, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Brian P. Kelly et al. (US 7895899 B2; hereinafter Kelly) in view of Hossein Mehdian (US 20160012753 A1; hereinafter Mehdian).
Regarding claim 1, Kelly discloses a spine simulator comprising: a frame (“testing system also include a frame” (recited in at least: Kelly [column 4, line 26])); a set of struts extending from the frame (“The frame defines a volume for receiving and supporting the coupled joint. Preferably, the testing system volume is capable of receiving coupled joints of varying lengths” (recited in at least: Kelly [column 4 lines 27-28])); a gimbal assembly slidably connected to the frame (“The gimbal connection allows for the simultaneous application of both in-plane and out-of-plane rotary degrees of freedom. The gimbal style design also allows for simultaneous application of the required rotations about two orthogonal axes, which intersect at a single point in space” (recited in at least: Kelly [column 15, lines 16-21])); a base assembly slidably connected to the set of struts, wherein the base assembly is approximately aligned with the gimbal assembly (the base assembly shown in FIG 8 of Kelly as element 816L) a first spine support on the base configured to receive a first end of a specimen spine (the first spine support shown in FIG 9 of Kelly as element 849 suggests to be configured to receive a first end of a specimen spine); a second spine support on the gimbal assembly configured to receive a second end of the specimen spine (the second spine support shown in FIG 9 of Kelly as element 802 suggests to be configured to receive a second end of the specimen spine); a set of pneumatic cylinders arranged to apply a force to the base (The actuation system may be a pneumatic system (recited in at least: Kelly [column 3 lines 41-34])); an electronic controller (“The controller applies selected forces, motions, or combinations thereof to the moving end of the coupled joint” (recited in at least: Kelly [column 3, lines 49-51])); and a plurality of sensors positioned in or on the specimen spine and coupled to the electronic controller (“FIG. 3 also shows that the testing system 300 includes signal lines from the force sensors 322 and 324 to the controller 340. The signal lines provide feedback to the controller 340 as to the amount of force sensed from loads applied through the servo actuation system 330” (recited in at least: Kelly [column 11, lines 40-44])), wherein the gimbal assembly comprises at least three rotary components and at least three sliding components (“FIG. 1 illustrates individual vertebra movements with reference to the anatomical planes. Three anatomical axes defined as "x," "y," and "z" are provided” (recited in at least: Kelly [column 5, lines 28-30])), wherein the base assembly comprises a load cell (“The force sensors 822, 824 are also referred to as load cells” (recited in at least: Kelly [column 12, lines 39-40])), wherein the electronic controller is coupled to the gimbal assembly, the base assembly, the set of pneumatic cylinders, the at least three rotary components, and the load cell to send instructions and receive data (“the servo actuation system 830 is controlled by a controller. (The controller is shown schematically at 840 in FIG. 10.) A control pendant is shown in the system 800 somewhat schematically at 842. In one aspect, an industrial robotic Adept controller from Adept Technologies is used. The Adept controller may be supplied with three small electrical wiring panels. Wiring panels are shown schematically in FIG. 10 at 845” (recited in at least: Kelly [column 12, lines 6-13])), and wherein the distance between the gimbal assembly and the base assembly can be varied to accommodate a specimen spine having a length between 2 vertebrae and 33 vertebrae (“The specimen 350 may be of any length. In this respect, the testing system 300 is designed to be adjustable so as to fit any series of coupled vertebrae, even from the torso to the head” (recited in at least: Kelly [column 7, lines 17-20])). However, Kelly does not explicitly disclose that the vertebrae can also include a pelvis.
Mehdian teaches a spine model with a pelvis attached to the vertebral column (shown in FIG 1-2, 8A, and 10A).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included a pelvis attached to the spine simulator to simulate accurate human anatomy.
Regarding claim 2, Kelly in view of Mehdian teach the claimed matter as stated above, and Kelly further teaches wherein the second spine support can be independently rotated by any one of the three rotary components (“The testing system 800 is specially programmed to selectively move and rotate the upper end 854 of the spinal test specimen 850 about a moving point of rotation within a selected plane. In robotic terms, the moving point of rotation may be referred to as the tool tip location 849, which is user defined” (recited in at least: Kelly column [18, lines 31-36])
Regarding claim 3, Kelly in view of Mehdian teach the claimed matter as stated above, and Kelly further teaches wherein the second spine support can be independently translated by any one of the three sliding components (“as the cervical spine flexes or extends and axially rotates, individual vertebrae rotate and translate within the sagittal plane. To replicate this motion, control over multiple planar movements representing at least four degrees of motion is desired” (recited in at least: Kelly [column 10, lines 13-17])).
Regarding claim 5, Kelly in view of Mehdian teach the claimed matter as stated above, and Kelly further teaches, wherein each of the at least three rotary components is driven by a dedicated stepper motor (“The actuation system may be a servo system, a stepper motor system, a hydraulic system, a pneumatic system, or a magnetic system” (recited in at least: Kelly [column 3 lines 41-34])).
Regarding claim 21, Kelly discloses a spine simulator comprising: a gimbal assembly (The gimbal connection allows for the simultaneous application of both in-plane and out-of-plane rotary degrees of freedom. The gimbal style design also allows for simultaneous application of the required rotations about two orthogonal axes, which intersect at a single point in space (recited in at least: Kelly [column 15, lines 16-21])); a base assembly approximately aligned with the gimbal assembly (the base assembly shown in FIG 8 of Kelly as element 816L); a first spine support on the base configured to receive a first end of a specimen spine (the first spine support shown in FIG 9 of Kelly as element 849 suggests to be configured to receive a first end of a specimen spine); a second spine support on the gimbal assembly configured to receive a second end of the specimen spine (the second spine support shown in FIG 9 of Kelly as element 802 suggests to be configured to receive a second end of the specimen spine); a set of pneumatic cylinders arranged to apply a force to the base (The actuation system may be a servo system, a stepper motor system, a hydraulic system, a pneumatic system, or a magnetic system (recited in at least: Kelly [column 3 lines 41-34])); an electronic controller (The controller applies selected forces, motions, or combinations thereof to the moving end of the coupled joint (recited in at least: Kelly [column 3, lines 49-51])); and a plurality of sensors positioned in or on the specimen spine and coupled to the electronic controller (FIG. 3 also shows that the testing system 300 includes signal lines from the force sensors 322 and 324 to the controller 340. The signal lines provide feedback to the controller 340 as to the amount of force sensed from loads applied through the servo actuation system 330 (recited in at least: Kelly [column 11, lines 40-44])), wherein the gimbal assembly comprises at least three rotary components to rotate the second spine support (instance, as the cervical spine flexes or extends and axially rotates, individual vertebrae rotate and translate within the sagittal plane. To replicate this motion, control over multiple planar movements representing at least four degrees of motion is desired (recited in at least: Kelly [column 10, lines 13-17])) and at least three sliding components to translate the second spine support, wherein the base assembly comprises a load cell (The force sensors 822, 824 are also referred to as load cells (recited in at least: Kelly [column 12, lines 39-40])), wherein the electronic controller is coupled to the gimbal assembly, the base assembly, the pneumatic cylinders, the rotary components, and the load cell to send instructions and receive data, and wherein the distance between the gimbal assembly (the servo actuation system 830 is controlled by a controller. (The controller is shown schematically at 840 in FIG. 10.) A control pendant is shown in the system 800 somewhat schematically at 842. In one aspect, an industrial robotic Adept controller from Adept Technologies is used. The Adept controller may be supplied with three small electrical wiring panels. Wiring panels are shown schematically in FIG. 10 at 845 (recited in at least: Kelly [column 12, lines 6-13])), and the base assembly can be varied to accommodate a specimen spine having a length between 2 vertebrae and 33 vertebrae (The specimen 350 may be of any length. In this respect, the testing system 300 is designed to be adjustable so as to fit any series of coupled vertebrae, even from the torso to the head (recited in at least: Kelly [column 7, lines 17-20])). However, Kelly does not explicitly disclose that the vertebrae can also include a pelvis.
Mehdian teaches a spine model with a pelvis attached to the vertebral column (shown in FIG 1-2, 8A, and 10A).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included a pelvis attached to the spine simulator to simulate accurate human anatomy.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Mehdian in further view of Christopher Raymond Dennison (US 20090247899 A1; Dennison).
Regarding claim 4, Kelly in view of Mehdian teach the claimed matter as stated above; however, they do not explicitly teach wherein the plurality of sensors comprises at least one of an extensometer, a strain sensor, a linear displacement sensor, and a pressure catheter positioned within at least one disc.
Dennison teaches adding a pressure sensor into at least one disc (FIG. 9 shows the pressure sensor inserted into an intervertebral disc. When compressive load is applied to the vertebrae of the spine, the center of the disc (the nucleus) responds with an increase in hydrostatic pressure (recited in at least: Dennison paragraph [0075])).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added sensors inside of the vertebral discs for the added benefit of adding resistance to bending and monitoring the pressure.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Mehdian in further view of Harmonic Drive LLC (“Harmonic Drive® Strain Wave Gear Technology” found at https://web.archive.org/web/20161103123707/https://www.harmonic
drive.net/technology/harmonicdrive (11/03/2016); hereinafter Harmonic Drive LLC).
Regarding claim 6, Kelly in view of Mehdian teach the claimed matter as stated above wherein at least one rotary component comprises sensors to produce torque from the stepper motor (The controller 340 receives force and torque information from the force sensors 322, 324, and solves the kinematic transformation matrices necessary to plan trajectory paths for the multi-axis movements (recited in at least: Kelly [column 11, lines 6-10])).
Harmonic Drive LLC teaches the use of harmonic strain wave gears to maximize output torque.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have used a harmonic strain wave gear to maximize output torque with a smaller gear system for the added benefit of making the system portable.
Claims 7, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly in view of Mehdian in further view of University of Washington, Department of Mechanical Engineering, Applied Biomechanics Laboratory ("Multi-Axis Spine Simulator" found at https://web.archive.org/web/20130308175554/https://depts.washington.edu/uwabl/UWABL_Simulator.pdf; March 8, 2013; hereinafter UW ABL).
Regarding claim 7, Kelly in view of Mehdian teach the claimed matter as stated above; however, they do not explicitly teach further comprising a 3D motion system, wherein the 3D motion system comprises a set of cameras positioned to take and send images and/or video of the frame with the specimen spine from at least two positions.
UW ABL teaches a 3D motion system, wherein the 3D motion system comprises a set of cameras positioned to take and send images and/or video of the frame with the specimen spine from at least two position (“The system includes four 1.3-million-pixel cameras positioned around the specimen such that they are able to track a set of reflective markers that are rigidly attached to each vertebral body. The system is capable of achieving a resolution of 0.05 mm/pixel within the capture volume of the spine simulator. Vicon Bodybuilder software is utilized to compute relative angles between the vertebrae and is capable of computing translations of each vertebral body as well” (recited in attached NPL)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included the camera system of UW ABL into the system of Kelly in view of Mehdian for the added benefit of enabling students to have study materials of the kinematic data collection.
Regarding claim 10, Kelly in view of Mehdian teach the claimed matter as stated above; however, they do not explicitly teach a muscle actuator coupled to the specimen spine.
UW ABL teaches a muscle actuator coupled to the specimen spine (“A variable compressive follower load may be applied along the lateral aspects of the spine to replicate axial physiologic muscle loading” (recited in attached NPL)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included the muscle actuator coupled to the specimen spine for the added benefit of maintaining the unloaded neutral position of a spine without introducing any artificial rotation between vertebral bodies after the load is applied (recited in attached NPL).
Regarding claim 11, Kelly in view of Mehdian in further view of UW ABL teaches the claimed matter as stated above, and UW ABLE further teaches a pulley system coupling the muscle actuator to a muscle on the specimen spine (“spectra fiber cable is looped through brackets that are rigidly attached to each vertebral body and then fed through a pulley system under the specimen for even load distribution” (recited in attached NPL)).
Claims Not Rejected by Prior Art
Claims 8-9 do not currently have a prior art rejection applied to them; however, they currently have 35 U.S.C. § 112(b) rejections applied to them. The closest prior art made of record for clam 8 is Amirhossein Salimi et al. (“Evaluation of Crossover Sign in Pelvis Models Made with a Three-Dimensional Printer” 26 May 2022; hereinafter Salimi). Salimi teaches a pelvis model holder (shown below); however, the model does not teach a bracket and a hook extending from the bracket as taught in the instant application. The prior art also does not teach that the hook secures the pelvis at the pubic symphysis as taught in the instant application.
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Conclusion
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/SELWA A ALSOMAIRY/Examiner, Art Unit 3715
/Jay Trent Liddle/Primary Examiner, Art Unit 3715