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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Re. Claims 1, 15, and 18 (and dependent claims thereof): Each of independent claims 1, 15, and 18 recite “a first implant coupled to a first bone of a joint; a second implant coupled to a second bone of the joint…” The claims should read instead as “a first implant configured to be coupled to a first bone of a joint; a second implant configured to be coupled to a second bone of the joint” in order to avoid encompassing a human organism.
Double Patenting
Claims 1, 15, and 18 of this application is patentably indistinct from claims 1, 15, and 18 of Application No. 18/108,954. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 15, and 18 and dependent claims thereof are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1, 15, and 18 of copending Application No. 18/108,954 (hereinafter – the ‘954 application) in view of
Stein et al. (US 20140171754 A1) (hereinafter – Stein) in view of
Sundaram et al. (US 20200237291 A1) (hereinafter – Sundaram).
This is a provisional nonstatutory double patenting rejection.
Re. Claim 1: The ‘954 application teaches a joint implant comprising:
a first implant coupled to a first bone of a joint (claim 1, line 2; see relevant portions of claims 15 and 18); and
a second implant coupled to a second bone of the joint (claim 1, line 2; see relevant portions of claims 15 and 18),
the second implant including:
a first sensor configured to measure a first type of data (claim 1, line 8: load sensor; see relevant portions of claims 15 and 18); and
a processor operatively coupled to the first sensor (claim 1, line 10; see relevant portions of claims 15 and 18).
The limitations of “wherein the processor outputs the first type of data to a network, and
wherein one of the joint, the first implant or the second implant is determined to be in a first state based on a comparison of the first type of data to a set of predetermined values,” are taught by Stein (see prior art rejections below).
It would have been obvious to one having skill in the art before the effective filing date to have modified the ‘954 application to include outputting to a network and determining a state of the implant based on comparison to predetermined values as taught by Stein, the motivation being that doing so allows for communication of results without a wired connection and analysis of the data by an appropriate model (e.g., one which provides predetermined threshold values to determine a state of the implant).
The ’954 application as modified by Stein does not teach the invention wherein the predetermined values are adapted to change with the addition of new data.
Such an aspect is taught by Sundaram. Motivation to modify the ‘954 application as modified by Stein is identical to that of the prior art rejections below.
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 1-6, 8-11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over:
Stein et al. (US 20140171754 A1) (hereinafter – Stein) in view of
Sundaram et al. (US 20200237291 A1) (hereinafter – Sundaram).
Re. Claim 1: Stein teaches A joint implant comprising:
a first implant coupled to a first bone of a joint (Fig. 1: femoral prosthetic component 104; Fig. 28: one of the hip joint prosthetic components shown; see similar structures in Fig. 29); and
a second implant coupled to a second bone of the joint (Fig. 1: tibial prosthetic component 106; Fig. 27; Fig. 28: the other of the hip joint prosthetic components shown; see similar structures in Figs. 29, 31, 33, 38, 40),
the second implant including:
a first sensor configured to measure a first type of data (Paragraph 0061: “Tibial prosthetic component 106 can include a cavity or tray on the major surface that receives and retains sensor 100 during a measurement process;” see similar structures in cited figures above); and
a processor operatively coupled to the first sensor (Fig. 1: data communication to receiving station 110; Fig. 28 as described in Paragraph 0198: “The electronic circuitry 2812 can further include a power source, power management circuitry, conversion circuitry, digital logic, processors, multiple input/output circuitry, and communication circuitry;” Paragraph 0200: “Remote system 2818 includes a display 2820 configured to display the measurement data. Remote system 2818 can be a computer that further processes the measurement data;” see similar components in Figs. 29, 38, 41, 42);
wherein the processor outputs the first type of data to a network (Figs. 1, 28, 29, 38: data communication to receiving station or remote system 3802; Fig. 41: network 4126; Fig. 42: communication network 4200), and
wherein one of the joint, the first implant or the second implant is determined to be in a first state based on a comparison of the first type of data to a set of predetermined values (Paragraph 0099: “In a non-limiting example, a parameter such as applied force is measured by relating the measured phase and frequency to a known relationship between the parameter (e.g. force) and the material properties of the energy propagating medium;” Paragraph 0101: continuous wave mode operation monitors change in length of propagation structure and uses known length to force relationship; Paragraph 0127: pulse-echo operation monitors change in length of propagation structure and uses known length to force relationship; Paragraphs 0155, 0164, 0192, 0227: capacitance change in known manner to determine a change in force, pressure, or load; Paragraph 0231: known location of load pad on support surfaces identify where load is coupled; Paragraphs 0248-250: comparison of optical sensor data to known infection color data to assess infection; Paragraphs 0252-0253: measurement of turbidity against known values, previous values, or predetermined turbidity range to identify infection).
Stein does not teach the invention wherein the predetermined values are adapted to change with the addition of new data.
Sundaram teaches analogous art in the technology of monitoring joint movement and conditions (Abstract). Sundaram teaches determination of a state of a joint based on an algorithm with inbuilt thresholds to identify particular movements, whereby such thresholds are adapted to change with the addition of new data (Paragraph 0144: sensors for detecting movement of a body portion include thresholds which “may take into account the likely movement of other joints. The algorithm may also have adaptive goals, wherein the thresholds are relaxed in the first few days after an operation and then slowly advanced. Thresholds may be adjusted according to one or more features including but not limited to: position of patient in recovery process, user profile, care plan, indications of other conditions or compensatory muscle or joint issues, and pain levels”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein to include the joint state monitoring and algorithm of Sundaram, the motivation that doing so allows for identification of patient recovery or indications of other conditions or compensatory muscle or joint issues and pain levels (Paragraph 0144).
Re. Claim 2: Stein as modified by Sundaram teaches the invention according to claim 1. Stein further teaches the invention wherein the joint is a knee joint, the first implant is a femoral implant and the second implant is a tibial implant (Fig. 1).
Re. Claim 3: Stein as modified by Sundaram teaches the invention according to claim 2. Stein further teaches the invention wherein the tibial implant includes any of
a pH sensor (Abstract: “The prosthetic component can include a… a pH sensor…”),
a temperature sensor (Abstract: “The prosthetic component can include a temperature sensor…”),
a Hall sensor,
a pressure sensor (at least: Paragraph 0058: “This relationship is used to generate accurate measurements of parameters such as distance, weight, strain, pressure, wear, vibration, viscosity, and density to name but a few;” Paragraph 0064: joint pressure visualization based on measured forces; Paragraph 0072: “As will be explained further hereinbelow, the sensing assembly 300 in one embodiment is part of a sensory device that measures a parameter such as force, pressure, or load;” Figs. 20, 26; Paragraphs 0140-0141),
an optical sensor (Abstract: “The prosthetic component can include… an optical sensor.”), and
a blood sensor (Paragraphs 0242, 0250: turbidity and color change can assess presence of blood in synovial fluid)
operatively coupled to the processor.
Re. Claim 4: Stein as modified by Sundaram teaches the invention according to claim 3. Stein further teaches the invention wherein the tibial implant includes a tibial insert and a tibial stem (Fig. 1: tibial prosthetic component 106; Figs. 31, 33, 35, 38-40: tibial prosthetic component 3100 includes tibial insert 3116 and stem 3124), and
wherein the tibial insert is made of polyethylene (Paragraph 0223: “Insert 3116 fits into the tray of prosthetic component. The tray of prosthetic component 3100 can have one or more features for retaining insert 3116. Insert 3116 typically comprises a polymer material such as ultra-high molecular weight polyethylene”).
Re. Claim 5: Stein as modified by Sundaram teaches the invention according to claim 1. Stein further teaches the invention wherein the processor outputs the data to an external source connected to the network (see citations of claim 1 – see additional external sources connected to networks identified), and
the joint implant further comprises a transmitter to transmit the first type of data to the external source (Paragraph 0063: “Data from sensor 100 is transmitted to a receiving station 110 via wired or wireless communications;” Examiner notes that this implies the existence of a transmitter to perform such a function).
Re. Claim 6: Stein as modified by Sundaram teaches the invention according to claim 1. Stein further teaches the invention further comprising a battery disposed within the second implant (Paragraph 0079: “A pulsed energy wave approach reduces power dissipation allowing for a temporary power source such as a battery or capacitor to power the system during the course of operation;” Paragraph 0193: “In one embodiment, a temporary power source such as a battery, capacitor, inductor, or other storage medium is located within insert 2700 to power the sensors and electronic circuitry 2704;” Paragraph 0205: “The electronic circuitry can include a power source such as a battery, inductive power source, super capacitor, or other storage medium”).
Re. Claim 8: Stein as modified by Sundaram teaches the invention according to claim 1. Stein further teaches the invention further comprising at least one of a second sensor configured to measure a second type of data (Fig. 37: optical sensors include LED 3708 and photo-diode array 3710 measure color and turbidity while load pads 3108 measure force/pressure/load and position thereof, as described in Paragraph 0243).
Re. Claim 9: Stein as modified by Sundaram teaches the invention according to claim 8. Stein further teaches the invention wherein the joint implant includes a plurality of the first sensor and a plurality of the second sensor (see citation of claim 8: optical “sensors” (i.e., plural) and plurality of load pads).
Re. Claim 10: Stein as modified by Sundaram teaches the invention according to claim 9. Stein further teaches the invention wherein the processor outputs the first and second types of data to the network (Paragraph 0257: “In a fourth step, the data sent by the prosthetic component can be analyzed. The data can be analyzed by the remote system. The data can also be sent to other equipment, devices, computers, or a database. The data can be combined with other information or data to create a clinical database related to a study of the joint or prosthetic system;” Figs. 41, 42).
Re. Claim 11: Stein as modified by Sundaram teaches the invention according to claim 1. Stein further teaches the invention wherein the addition of new data includes the first type of data output by the processor of the joint implant (see modification in view of Sundaram – Sundaram receives data which includes the same type of data).
Re. Claim 13: Stein as modified by Sundaram teaches the invention according to claim 1. Stein further teaches the invention wherein the joint implant is configured to initiate a warning when the joint implant is determined to be in the first state (Paragraph 0238: “Prosthetic joint 3100 can detect infection local to the joint, notify a doctor or healthcare provider, or take appropriate action in a timely manner”).
Re. Claim 14: Stein as modified by Sundaram teaches the invention according to claim 11. Stein further teaches the invention wherein the first state is any one of inflamed, infected, or injured (Paragraphs 0248-250: comparison of optical sensor data to known infection color data to assess infection; Paragraphs 0252-0253: measurement of turbidity against known values, previous values, or predetermined turbidity range to identify infection).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over
Stein et al. (US 20140171754 A1) (hereinafter – Stein) in view of
Sundaram et al. (US 20200237291 A1) (hereinafter – Sundaram) in further view of
Trousdale et al. (US 20200107945 A1) (hereinafter – Trousdale).
Re. Claim 7: Re. Stein as modified by Sundaram teaches the invention according to claim 1, but does not teach wherein the joint is a shoulder joint, the first implant is a glenoid sphere and the second implant is a shoulder insert.
Trousdale teaches analogous art in the technology of sensing systems for prostheses (Abstract). Trousdale further teaches the invention wherein the joint is a shoulder joint, the first implant is a glenoid sphere and the second implant is a shoulder insert (Figs. 1, 2; Paragraphs 0077, 0216, 0217: referring to sensor positioning in second implant).
Stein already contemplates their invention being positioned in a shoulder joint (Paragraph 0062). The teachings of Trousdale are a suitable method of applying a joint implant having sensor(s) in a shoulder joint. Thus, it would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include applying the joint implant of Stein as modified by Sundaram in a shoulder joint as taught by Trousdale, since the claimed invention is merely a combination of old elements (Stein as modified by Sundaram: a joint implant having first and second parts and sensor(s) which may be applied to shoulder; Trousdale: teaching an analogous system having a suitable structure for implantation into a shoulder), and in the combination each element merely would have performed the same function as it did separately (forming a sensing implant), and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over
Stein et al. (US 20140171754 A1) (hereinafter – Stein) in view of
Sundaram et al. (US 20200237291 A1) (hereinafter – Sundaram) in further view of
Morgan et al. (US 20060052782 A1) (hereinafter – Morgan).
Re. Claim 12: Stein as modified by Sundaram teaches the invention according to claim 11. Sundaram, in the modification, teaches considering movement of other joints, but does not explicitly recite receiving data from other joint implants.
Morgan teaches analogous art in the technology of orthopedic implants with sensors (Abstract; Title). Morgan further teaches receiving data from other joint implants (Paragraph 0028: “Moreover, microchips 40 located in one implant 10 can send and receive data to and from other implants. For example, a bone plate 10 located at one fracture site can send data to another plate 10 located at a different fracture site in the same or a different bone. Similarly, pedicle screws at one location can receive data from other pedicle screws, hooks or fixation rods. The implants of the present invention may also be used at an impending pathological fracture site, where information concerning increasing strain on the implant would indicate that the affected bone is weakening. Similarly, such implants could also be employed at locations where osteotomies or resections have been performed to monitor bone strength”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein to include receiving sensor data from other joint implants as taught by Morgan, the motivation being that sensors located at joints specifically allow for a more precise monitoring of motion of other joints to allow for a more accurate accounting of such movement in the algorithm incorporated by Sundaram.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over
Stein et al. (US 20140171754 A1) (hereinafter – Stein) in view of
Morgan et al. (US 20060052782 A1) (hereinafter – Morgan).
Re. Claim 15: Stein teaches a joint implant comprising:
a first implant coupled to a first bone of a joint (Fig. 1: femoral prosthetic component 104; Fig. 28: one of the hip joint prosthetic components shown; see similar structures in Fig. 29); and
a second implant coupled to a second bone of the joint and contacting the first implant (Fig. 1: tibial prosthetic component 106; Fig. 27; Fig. 28: the other of the hip joint prosthetic components shown; see similar structures in Figs. 29, 31, 33, 38, 40),
the second implant including:
a first sensor configured to measure a first type of data (Paragraph 0061: “Tibial prosthetic component 106 can include a cavity or tray on the major surface that receives and retains sensor 100 during a measurement process;” see similar structures in cited figures above);
a second sensor configured to measure a second type of data (Fig. 37: optical sensors include LED 3708 and photo-diode array 3710 measure color and turbidity while load pads 3108 measure force/pressure/load and position thereof, as described in Paragraph 0243); and
a processor operatively coupled to the at least one of the first and second sensors (Fig. 1: data communication to receiving station 110; Fig. 28 as described in Paragraph 0198: “The electronic circuitry 2812 can further include a power source, power management circuitry, conversion circuitry, digital logic, processors, multiple input/output circuitry, and communication circuitry;” Paragraph 0200: “Remote system 2818 includes a display 2820 configured to display the measurement data. Remote system 2818 can be a computer that further processes the measurement data;” see similar components in Figs. 29, 38, 41, 42);
wherein the joint implant is configured to initiate an alert when the joint implant is determined to be in a first state (Paragraph 0238: “Prosthetic joint 3100 can detect infection local to the joint, notify a doctor or healthcare provider, or take appropriate action in a timely manner).
Stein teaches outputting joint implant sensor data (including first and second types) to a network to determine a state of the joint implant (Figs. 1, 28, 29, 38: data communication to receiving station or remote system 3802; Fig. 41: network 4126; Fig. 42: communication network 4200). However, Stein does not teach that the network is connected to other joint implants to derive a state of the joint implant.
Morgan further teaches receiving data from other joint implants (Paragraph 0028: “Furthermore, it should be emphasized that multiple microchips 40 and/or multiple sensors 50 may be provided for a single fixation device to monitor different segments of the fixation device or to monitor different types of sensors (e.g. strain, pressure, temperature, cycle count) provided with the plate. Moreover, microchips 40 located in one implant 10 can send and receive data to and from other implants. For example, a bone plate 10 located at one fracture site can send data to another plate 10 located at a different fracture site in the same or a different bone. Similarly, pedicle screws at one location can receive data from other pedicle screws, hooks or fixation rods. The implants of the present invention may also be used at an impending pathological fracture site, where information concerning increasing strain on the implant would indicate that the affected bone is weakening. Similarly, such implants could also be employed at locations where osteotomies or resections have been performed to monitor bone strength”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the network of Stein to include receiving data from other joint implants as taught by Morgan, the motivation being that doing so enables additional data to be considered from to identify if a local joint or bone where a prosthesis is attached thereto is weakening (Paragraph 0028).
Re. Claim 16: Stein as modified by Sundaram teaches the invention according to claim 15. Stein, in light of modification by Morgan, further teaches the invention wherein the data received from other joint implants includes data measured by a sensor (see Morgan, Paragraph 0028: “Moreover, microchips 40 located in one implant 10 can send and receive data to and from other implants. For example, a bone plate 10 located at one fracture site can send data to another plate 10 located at a different fracture site in the same or a different bone. Similarly, pedicle screws at one location can receive data from other pedicle screws, hooks or fixation rods. The implants of the present invention may also be used at an impending pathological fracture site, where information concerning increasing strain on the implant would indicate that the affected bone is weakening. Similarly, such implants could also be employed at locations where osteotomies or resections have been performed to monitor bone strength).
Re. Claim 17: Stein as modified by Sundaram teaches the invention according to claim 16. Stein, in light of modification by Morgan, teaches the invention wherein the data received from the other joint implants includes determinations of a state of the respective joint or a state of the respective implant as determined by a user (see citation of Paragraph 0028: data received from other implants include information of respective implant area, i.e., a respective joint as utilized in the modification of Stein).
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over
Stein et al. (US 20140171754 A1) (hereinafter – Stein) in view of
Sarkela et al. (US 20180008207 A1) (hereinafter – Sarkela).
Re. Claim 18: Stein teaches a system for detecting a state of a joint implant comprising: a joint implant including:
a first implant coupled to a first bone of a joint (Fig. 1: femoral prosthetic component 104; Fig. 28: one of the hip joint prosthetic components shown; see similar structures in Fig. 29);
a second implant coupled to a second bone of the joint and contacting the first implant (Fig. 1: tibial prosthetic component 106; Fig. 27; Fig. 28: the other of the hip joint prosthetic components shown; see similar structures in Figs. 29, 31, 33, 38, 40),
the second implant including:
at least one of a first sensor configured to measure a first type of data (Paragraph 0061: “Tibial prosthetic component 106 can include a cavity or tray on the major surface that receives and retains sensor 100 during a measurement process;” see similar structures in cited figures above); and
a processor operatively coupled to the at least one of the first sensor (Paragraph 0184: “In the present invention parameters are measured with an integrated wireless sensing module or device comprising an i) encapsulating structure that supports sensors and contacting surfaces and ii) an electronic assemblage that integrates a power supply, sensing elements, an accelerometer, antennas, electronic circuitry that controls and processes a measurement sequence, and wireless communication circuitry;” Fig. 28 as described in Paragraph 0198: “The electronic circuitry 2812 can further include a power source, power management circuitry, conversion circuitry, digital logic, processors, multiple input/output circuitry, and communication circuitry”); and
a device operatively coupled to the processor (Fig. 1: data communication to receiving station 110; Paragraph 0200: “Remote system 2818 includes a display 2820 configured to display the measurement data. Remote system 2818 can be a computer that further processes the measurement data;” see similar components in Figs. 29, 38, 41, 42; Paragraph 0260: system which executes the methods, which may be standalone or networked deployment).
While Stein teaches that a sensor implant communicatively coupled to a processor which is capable of interfacing with a network to communicate with another device (i.e., a general computer or server), Stein does not teach the device receiving data from a second source in order to process such data and output a state of the joint based on such data.
Sarkela teaches analogous art in the technology of patient monitoring (Abstract). Sarkela teaches a system which monitors incoming data signals from sensors and compares such signals to alarm conditions (Paragraph 0007), akin to the sensors of the implant of Stein capable of providing data to a physician (e.g., Stein, Paragraphs 0182, 0190, 0200, 0202, 0205). The system of Sarkela also takes into account reactive inputs which include querying a user as to whether an observed alarm condition is an actionable event (Paragraph 0008). Thus, Sarkela teaches a system which processes both sensor input as well as input from a second source, i.e., a third-party observer or the patient, to assess a state of sensor data (e.g., sensor readings indicating an alarm condition).
It would have been obvious to one having skill in the art before the effective filing date to have modified the invention of Stein to include receiving data from both sensors and a second source (such as the reactive inputs of Sarkela) to assess a state of the joint, the motivation being that allowing a trained third party to provide input on sensor measurements allows for appropriate adjustment of alarm conditions and accurate assessment of whether sensor data indicates a concerning condition (Paragraph 0004: identification of clinically relevant alarms and false positive rates).
Re. Claim 20: Stein as modified by Sarkela teaches the invention according to claim 18. Sarkela further, in the modification of Stein, further teaches the invention wherein the second source includes a determination of a state of a joint based on data provided by sensors of a joint implant as determined by a user (see citation of rejection of claim 18 – a user of the system may provide feedback; alternatively or additionally, a physician or medical personnel assessing such feedback or alarm limits may also be considered a user of the device).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over
Stein et al. (US 20140171754 A1) (hereinafter – Stein) in view of
Sarkela et al. (US 20180008207 A1) (hereinafter – Sarkela) in further view of
Morgan et al. (US 20060052782 A1) (hereinafter – Morgan).
Re. Claim 19: Stein as modified by Sarkela teaches the invention according to claim 18. Stein teaches outputting joint implant sensor data (including first and second types) to a network to determine a state of the joint implant (Figs. 1, 28, 29, 38: data communication to receiving station or remote system 3802; Fig. 41: network 4126; Fig. 42: communication network 4200). However, Stein does not teach that the network is connected to other joint implants to derive a state of the joint implant. Stein as modified by Sarkela thus does not teach wherein the second source includes a second joint implant including at least one of a first sensor configured to measure a first type of data.
Morgan further teaches receiving data from other joint implants, including data of sensors of the same type (Paragraph 0028: “Furthermore, it should be emphasized that multiple microchips 40 and/or multiple sensors 50 may be provided for a single fixation device to monitor different segments of the fixation device or to monitor different types of sensors (e.g. strain, pressure, temperature, cycle count) provided with the plate. Moreover, microchips 40 located in one implant 10 can send and receive data to and from other implants. For example, a bone plate 10 located at one fracture site can send data to another plate 10 located at a different fracture site in the same or a different bone. Similarly, pedicle screws at one location can receive data from other pedicle screws, hooks or fixation rods. The implants of the present invention may also be used at an impending pathological fracture site, where information concerning increasing strain on the implant would indicate that the affected bone is weakening. Similarly, such implants could also be employed at locations where osteotomies or resections have been performed to monitor bone strength”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the network of Stein as modified by Sarkela to include receiving data from other joint implants as taught by Morgan, the motivation being that doing so enables additional data to be considered from to identify if a local joint or bone where a prosthesis is attached thereto is weakening (Paragraph 0028).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/ Primary Examiner, Art Unit 3791
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