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 .
Claim Objections
Claims 1, 2, 4, 5, 7-10, and 13-14 objected to because of the following informalities:
In claim 1, line 5, “the or each artificial ligament” should read “the at least one artificial ligament”.
In claim 1, line 6, “of a different bone” should read “wherein the anchoring points are on different artificial bones”.
In claim 1, line 8, as well as in claims 2, 4, 5, 7, 10, and 13, “each artificial ligament” should read “the at least one artificial ligament”.
In claim 2, line 2, “at least two artificial bones” should read “the at least two artificial bones”.
In claim 8, line 4, “the artificial ligaments” should read “the at least one artificial ligament”.
In claim 9, line 2, “at least one artificial bone” should read “at least one of the at least two artificial bones”.
In claim 10, line 4, “the or each knee state” should read “the at least one knee state”.
In claim 14, line 1, “wherein the two actuators are two stepper motors” should read “wherein the at least two actuators are stepper motors”.
Appropriate correction is required.
Claim Interpretation
Claim 7 recites the limitation “a locking system” and claim 8 recites the limitation “a jaw”. For clarity, Examiner notes that based on Fig. 3 and page 7, lines 19-33, the limitations are referring to a clamp/vise style brace to maintain tension in the artificial ligaments by clamping down on the ligaments to relieve tension from the actuators/motors. The claims are interpreted as such in order to provide clarity that the “jaw” is not a jaw bone/muscle as part of the model but a “jaw” like clamp as pictured in figure 3.
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 1-15 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.
Claim 1 recites the limitation “the other artificial ligaments” in line 10. Claim 1, line 5 recites “at least one artificial ligament” which renders the limitation of “the other artificial ligaments” indefinite as there would be no “other” ligaments if there is only one ligament as the claim recites “at least one” which includes there being only one artificial ligament. Therefore, it is unclear what the inventor or a joint inventor regards as the invention.
Claims 2-15 are rejected by virtue of their dependency from claim 1.
Claim 6, in line 2, recites the limitation “at least two actuators” and specified that each actuator is linked to a single artificial ligament. However, claim 1 recites the simulator comprises “at least one artificial ligament” such that the simulator could include a single artificial ligament wherein the two actuators cannot be connected as claimed. Therefore, it is unclear if the simulator is supposed to include at least two ligaments or if the second actuator is not connected to anything. It is recommended that Applicant amend the claim to include the simulator comprising at least two artificial ligaments or at least one actuator to coincide with the recitation of claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6, and 12 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wilkins (US PGPub 20090305215).
With regard to claim 1, Wilkins teaches a ligament joint simulator (Abstract; Figs. 1C, 3A; Paragraphs 0033, 0061 teach an orthopedic training simulator including a skeletal structure including joints and simulated muscles) comprising:
at least two artificial bones (Fig 1C; Paragraph 0036 teaches the skeleton includes a plurality of members (bones) and joints);
for each artificial bone, at least one anchoring point on the artificial bone (Figs 3A-4B; Paragraph 0040 show the cable attached to the pelvis and femur bones);
at least one artificial ligament, the or each artificial ligament linking two anchoring points of a different artificial bone (Figs 3A-4B; Paragraphs 0040, 0042, 0044 teach the simulator includes cables routed within the interior of the mannequin through sheaths and connecting the various bones with variable amounts of tension thereby connecting two bones at a joint as shown for the pelvis and femur); and
an adjuster linked to the artificial ligaments, the adjuster being configured to vary at least one biomechanical characteristic of each artificial ligament between the two associated anchoring points independently of the other artificial ligaments (Figs 3A-4B; Paragraphs 0040, 0042-0044, 0046 teach the simulator includes a motor or motors connected to the cables to vary the tension and length as pictured between figures 3A and 3B);
wherein the adjuster is configured to receive, for each artificial ligament, an associated control signal (Paragraphs 0042-0043, 0045-0046 teach the motors are controlled by a computer system); and
the adjuster is configured to automatically adjust the length of each artificial ligament based on the associated control signal (Paragraphs 0042-0043, 0045-0046 teach the motors are controlled by a computer system to vary the tension and length of the cables as pictured between figures 3A and 3B).
With regard to claim 2, Wilkins further teaches wherein the ligament simulator is a ligament knee simulator, at least two artificial bones each being selected from the group consisting of: an artificial femur, an artificial tibia, an artificial patella, and an artificial fibula (Fig 1C shows the simulator including a skeletal structure including a femur, tibia, patella, and fibula; it is noted that paragraphs 0034, 0037, 0053 teach that the simulator can be portions of a skeleton rather than a full skeleton).
With regard to claim 6, Wilkins further teaches wherein the adjuster comprises at least two actuators, each actuator being linked to a single artificial ligament and configured to vary the length of the ligament according to the associated control signal (Figs 3A-4B; Paragraphs 0009, 0040, 0043-0046, 0058 teach that different joints can include the cable-tension feature wherein each cable can include a motor or motors such that each motor (actuator) is connected to a single cable (ligament) and controlled by the computer program driving one or more motors to simulate the desired circumstance).
With regard to claim 12, Wilkins further teaches further comprising an envelope defining an internal volume wherein the artificial bones are arranged, a foam filling the internal volume (Figs 1A-1C; Paragraphs 0033-0035 teach the simulator is a mannequin including a covering (envelope) of foam surrounding the internal skeleton).
Claim(s) 1, 4, 6, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (“Artificial muscles for jaw movements” NPL, see attached for citations).
With regard to claim 1, Wang teaches a ligament joint simulator (Fig. 1; Page 89, Col 1, Paragraph 1 teach an artificial muscle for simulating jaw movement) comprising:
at least two artificial bones (Fig. 1; Page 89, Col 2, Paragraph 1 teach the model includes the temporal bones of a skull and a mandible);
for each artificial bone, at least one anchoring point on the artificial bone (Fig. 1; Page 89, Col 1, Paragraph 2 teach the actuators are attached by clamps (anchoring point) to both the cheek (skull bone) and the jaw);
at least one artificial ligament, the or each artificial ligament linking two anchoring points of a different artificial bone (Fig. 1; Page 89, Col 1, Paragraph 2 teach the actuators (artificial ligament) are attached by clamps (anchoring point) to both the cheek (skull bone) and the jaw); and
an adjuster linked to the artificial ligaments, the adjuster being configured to vary at least one biomechanical characteristic of each artificial ligament between the two associated anchoring points independently of the other artificial ligaments (Page 89; Page 90; Page 94, Col 1, Paragraph 2-3 teach the actuators are controllable by a controller applying voltage to the actuators to change the length, thickness, and extension/tension of the actuators);
wherein the adjuster is configured to receive, for each artificial ligament, an associated control signal (Page 89; Page 90; Page 94, Col 1, Paragraph 2-3 teach the actuators are controllable by a controller applying voltage (control signal) to the actuators to change the length, thickness, and extension/tension of the actuators); and
the adjuster is configured to automatically adjust the length of each artificial ligament based on the associated control signal (Page 89; Page 90; Page 94, Col 1, Paragraph 2-3 teach the actuators are controllable by a controller applying voltage to the actuators to change the length, thickness, and extension/tension of the actuators).
With regard to claim 4, Wang further teaches wherein each artificial ligament is composed of a material chosen form the group consisting of: polypropylene (Page 89, Col 2, Paragraph 1; Page 90, Col 1, Paragraph 2); polyamide (Page 90, Col 2, Paragraph 1; Page 92, Col 1, Paragraph 1; “nylon” which is a polyamide); and elastomer material (Page 89, Col 1, Paragraph 1; Page 90, Col 1, Paragraph 2; “dielectric elastomer”).
With regard to claim 6, Wang further teaches wherein the adjuster comprises at least two actuators, each actuator being linked to a single artificial ligament and configured to vary the length of the ligament according to the associated control signal (Fig. 1; Page 89; Page 90; Page 94, Col 1, Paragraph 2-3 show two actuators and teach the actuators are controllable by a controller applying voltage to the actuators to change the length, thickness, and extension/tension of the actuators).
With regard to claim 13, Wang further teaches wherein each artificial ligament is composed of nylon (Page 90, Col 2, Paragraph 1; Page 92, Col 1, Paragraph 1; “nylon”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkins in view of Wang.
With regard to claim 3, Wilkins may not explicitly teach wherein at least two artificial ligaments have a different cross-section surface area. As discussed above, Wang teaches an artificial muscle for simulating jaw movement attached to the skull and jaw bones in the form of an actuator (Fig. 1; Page 89, Col 1, Paragraph 1; Page 89, Col 1, Paragraph 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wilkins to incorporate the teachings of Wang by incorporating the actuator/artificial muscle of Wang as part of the simulator of Wilkins, as both references and the claimed invention are directed to simulated human joint models. One of ordinary skill in the art would modify Wilkins by including the actuator of Wang on the jaw and skull portion of the mannequin to simulate jaw movement and allow for jaw based procedures wherein the actuator of Wang is a different cross-sectional area compared to the wires/cables of Wilkins. The actuator would be controlled by the computer program/system of Wilkins to simulate desired joint configurations. Upon such modification, the method and system of Wilkins would include wherein at least two artificial ligaments have a different cross-section surface area. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Wang with Wilkin’s system and method in order to further simulate joint movements and configurations and create a more lifelike simulator/mannequin.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkins in view of Zhang et al. (“SMA-based bionic integration design of self-sensor–actuator-structure for artificial skeletal muscle” NPL, see attached for citations).
With regard to claim 5, Wilkins may not explicitly teach wherein each artificial ligament consists of a spring with variable stiffness arranged between the two associated anchoring points. However, Zhang teaches an artificial skeletal muscle using an SMA wire including a bias spring attached to the wire between the connection points of the wire in order to provide variable stiffness and bias in order to simulate energy storing of muscles (Figs. 4, 5, 13; Page 96, Col 2, Paragraph 2; Page 100, Col 2, Paragraph 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wilkins to incorporate the teachings of Zhang by incorporating the bias spring of Zhang as part of the cable tension system of Wilkins, as both references and the claimed invention are directed to simulated human joint models. One of ordinary skill in the art would modify Wilkins by including the spring of Zhang as part of each wire to provide variable stiffness and simulate muscle tendency to a standard position and provide variable load on the muscles and joints to further simulate muscle behavior. Upon such modification, the method and system of Wilkins would include wherein each artificial ligament consists of a spring with variable stiffness arranged between the two associated anchoring points. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Zhang with Wilkin’s system and method in order to create a more lifelike simulator/mannequin and provide variable load conditions and further simulate muscle behavior for orthopedic training.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkins in view of Browne-Wilkinson (US PGPub 20080286736).
With regard to claim 9, Wilkins may not explicitly further comprising a fixed support, at least one artificial bone being connected to the fixed support by a ball joint. However, Browne-Wilkinson teaches an orthopedic demonstration aid wherein a model of a leg or hip can be attached to a holding mechanism (fixed support) via a ball joint (Figs. 4-6; Paragraphs 0028, 0030).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wilkins to incorporate the teachings of Browne-Wilkinson by incorporating the holding mechanism of Browne-Wilkinson to mount a partial model of Wilkins, as both references and the claimed invention are directed to orthopedic models. One of ordinary skill in the art would modify Wilkins by attaching a portion/partial model of a hip (as pictured in figures 3A-4B) or a leg via a ball joint to the holding mechanism to perform targeted demonstrations/simulations on only that portion of a skeletal model. Upon such modification, the method and system of Wilkins would include further comprising a fixed support, at least one artificial bone being connected to the fixed support by a ball joint. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Browne-Wilkinson with Wilkin’s system and method in order to provide proper support to a partial model and provide targeted simulation of a specific portion of a skeletal-muscle system.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkins in view of Riener et al. (US PGPub 20040254771), hereinafter referred to as Riener.
With regard to claim 10, Wilkins further teaches further comprising a human-machine interface (Fig. 1; Paragraphs 0055, 0057; “computer system” including a user interface), a control system (Fig. 1; Paragraphs 0055, 0057; “computer system”), and a database (Paragraphs 0058, 0060, 0061 teach the simulator includes configurations wherein the motors apply or remove tension as commanded based on the configuration); the human-machine interface being configured to acquire, from a user of the simulator, an instruction associated with one of the knee states (Paragraphs 0057-0059 teach the user can configure the simulator for a given procedural simulation), the control system being configured to receive said instruction and to send to the adjuster a control signal for each artificial ligament corresponding to the predefined length associated with said knee state in the database (Paragraphs 0046, 0058 teach the computer system (control system) can control the motor or motors to vary the tension (and thereby length) of the cables for a given procedure wherein the motors can control individual cables (each ligament)).
Wilkins may not explicitly teach the database including data relating to at least one knee state, the or each knee state being characterized by a predefined length for each artificial ligament between the two associated anchoring points. However, Riener teaches a joint simulator including a teaching mode wherein the simulator follows a preset (stored) operation and/or using parameters from a library (database) for a knee model in order to guide an operator on optimal performance (Paragraphs 0161, 0210, 0214).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wilkins to incorporate the teachings of Riener by applying the technique of using a library of parameters and preset trajectories of Riener for the system of Wilkins, as both references and the claimed invention are directed to joint/orthopedic simulators. One of ordinary skill in the art would modify Wilkins by coding the system to include a library of preset parameters to be applied by the computer system to the motors to adjust the cable tension/length for a desired procedure including knee joints such that a procedure or configuration (state) would be retrieved from the library/database. Upon such modification, the method and system of Wilkins would include the database including data relating to at least one knee state, the or each knee state being characterized by a predefined length for each artificial ligament between the two associated anchoring points. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Riener with Wilkin’s system and method in order to provide appropriate training and use preset configurations to improve efficiency.
With regard to claim 11, Wilkins teaches the simulator includes torque and position sensors (Paragraph 0035) but may not explicitly teach further comprising at least one accelerometer attached to one of the artificial bones and a memory configured to store acceleration measurements made by each accelerometer over time. However, Riener further teaches the simulator can include accelerometer sensors for gathering operator performance data which is recorded (stored) (Paragraphs 0163, 0216).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wilkins to incorporate the teachings of Riener by applying the technique of using an accelerometer sensor to measure user performance of Riener for the system of Wilkins, as both references and the claimed invention are directed to joint/orthopedic simulators. One of ordinary skill in the art would modify Wilkins by including accelerometer sensors in the system to record user actions on the simulator and coding the system to record and store the sensor data along with the other sensor data of Wilkins. Upon such modification, the method and system of Wilkins would include further comprising at least one accelerometer attached to one of the artificial bones and a memory configured to store acceleration measurements made by each accelerometer over time. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Riener with Wilkin’s system and method in order to provide further monitoring of user operations and as accelerometers are well-known sensors in the art for recording simulator data.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkins in view of Wen et al. (US PGPub 20170169734), hereinafter referred to as Wen.
With regard to claim 14, Wilkins may not explicitly teach wherein the two actuators are two stepper motors. However, Wen teaches a dynamic phantom including a stepper motor for manipulating and driving a gear and shaft as well as a pulley and wire for animating the phantom (Paragraphs 0063-0065, 0072).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wilkins to incorporate the teachings of Wen by substituting the stepper motor of Wen for the motors of Wilkins, as, while the simulators are different structures, both references and the claimed invention are directed to medical simulators/dynamic mannequins and it would have been obvious to one of ordinary skill to use a stepper motor as it is a known alternative used to provide accurate control without a feedback sensor (Wen Paragraph 0063). One of ordinary skill in the art would modify Wilkins by substituting stepper motors for the motors to control the cable tension. Upon such modification, the method and system of Wilkins would include wherein the two actuators are two stepper motors. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Wen with Wilkin’s system and method in order to provide accurate control without a feedback sensor and as stepper motors are well-known types of electronic motors.
Conclusion
Accordingly, claims 1-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached at (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CORRELL T FRENCH/Examiner, Art Unit 3715