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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications
filed in GB on 07/31/2020 and 12/21/2020. It is noted, however, that applicant has not filed a
certified copy of GB2011995.4 and GB2020209.9, respectively, as required by 37 CFR 1.55.
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: a power supply arrangement and at least one alerting device in claim 29.
Prong 1: “arrangement” and “device” are generic placeholders. See MPEP 2181 §I, subsection A, ¶1.
Prong 2: the transition word “to” is used, followed by functional language:
“a power supply arrangement configured to provide power to the deformation sensing arrangement”; and
“at least one alerting device configured to provide an audible and/or visual alert to a user”.
Prong 3: there is not sufficient structure to modify the generic placeholders “arrangement” and “device”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The examiner interprets the capacitor (specification pg. 6, ¶2-3 and pg. 17, ¶2), battery (specification pg. 10, ¶2 and pg. 21, ¶5), and external power (specification pg. 24, ¶4 – pg. 26, ¶2) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the power supply arrangement.
The examiner interprets the user device (specification pg. 20, last paragraph – pg. 21, ¶2; Fig. 2b); and mobile device, smartphone, tablet, computer, and smartwatch (specification pg. 6, ¶4) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the at least one alerting device.
If applicant does not intend to have this/these limitation(s) 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 Objections
Claims 29-31, 35, 38, and 40 are objected to because of the following informalities:
in claim 29, line 13: “respective” should be inserted before “location”;
in claim 29, line 14: “respective” should replace “particular”;
in claim 29, line 21: a comma should be inserted after “arrangement”;
in claim 29, line 22: “a plurality of” should be inserted before “measurements”;
in claim 29, line 25: “short range” should be “short-range”;
in claim 29, line 27: “indicative of deformation” should be inserted after “measure”;
in claim 29, line 40: a comma should be inserted after “pose”;
in claim 30, line 2: “strain in” should be “strain along”;
in claim 31, line 2: “fiber and including” should be “fiber, wherein the photonic integrated circuit includes”;
in claim 35, line 2: “short range” should be “short-range”;
in claim 35, line 5: a comma should be inserted after “wide area”;
in claim 35, line 7: a comma should be inserted after “wide area”;
in claim 38, line 6: “measurement” should be “reading”; and
in claim 40, line 2: a comma should be inserted after “adhesive”.
Appropriate correction is required.
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 29-47 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 29 recites the limitation “the particular range of wavelengths” in line 13. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a particular range of wavelengths” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 29 recites the limitation “the particular Bragg grating” in line 14. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a particular Bragg grating” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 29 recites the limitation “the vicinity” in line 24. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a vicinity” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 29 recites the limitation “the predetermined pose” in line 37. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a predetermined pose” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claims 30-47 are rejected by virtue of their dependence from claim 29.
Claim 30 recites “including processing logic” in line 1; however, it is not clear what includes the processing logic: the processor, the external user device, the remote server, or something else. Appropriate clarification is required.
Claim 42 recites several recitations that appear to be related to recitations in claim 29. There are recitations including indefinite articles: “an internal bone” in line 1 (see claim 1, line 1), “a patient” in line 1 (see claim 1, line 1), “a week” in lines 1-2 (see claim 1, line 2), “a period” in line 2 (see claim 1, lines 2-3), “an audible and/or visual alert” in line 4 (see claim 1, line 36), “a predetermined pose” in line 5 (see claim 1, line 37), “one or more sensors and/or one or more indications” in line 7 (see claim 1, line 39), “a measurement indicative of strain of the implantable reinforcement structure” in lines 16-17 (see claim 1, lines 23-24), “a signal” in line 18 (see claim 1, line 37), and “measurement data” in line 20 (see claim 1, lines 34-35). There are also recitations including definite articles: “the system of claim 29” in line 2 (see claim 1, line 1), “the at least one alerting device” in line 4 (see claim 1, line 36), “the user” in line 4 (see claim 1, line 37), “the external user device” in line 6 (see claim 1, line 25), “the first communications interface” in line 9 (see claim 1, line 30), “the implantable load-bearing fixation and sensing device” in line 10 (see claim 1, line 4), “the first signal” in line 10 (see claim 1, line 25), “the processor” in lines 10-11 (see claim 1, line 21), “the power supply arrangement” in line 11 (see claim 1, line 17), “the deformation sensing arrangement” in lines 11-12 (see claim 1, line 6), “the second interface” in lines 20-21 (see claim 1, line 34), and “the remote server” in line 21 (see claim 1, line 35). The definite articles suggest that the respective recitations are related/the same, but the indefinite articles suggest that the respective recitations are different. If the respective recitations are the same, the present recitations should use a definite article. If the recitations are different, the relationship between the respective recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). Consistent correction and clarification is required.
Claims 43-44 are rejected by virtue of their dependence from claim 42.
Claim 43 recites the limitation “the fracture” in line 2. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “the injury” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 44 is rejected by virtue of its dependence from claim 43.
Claim 44 recites “which may be as a classification or a value indicative of treatment progress” in lines 5-6. However, the phrase “which may be as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Amending the recitation to “the output being a classification or a value indicative of treatment progress” would overcome the present rejection. The claim is being read as such for the purposes of examination.
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.
Claims 29-30, 32-37, 39-40, 42-44, and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Mikhail et al. (US Patent Application Publication 2022/0022807), hereinafter Mikhail, in view of Buescher et al. (US Patent Application Publication 2016/0374561), hereinafter Buescher, and further in view of Windolf (US Patent Application Publication 2022/0395223 – cited in prior action).
Regarding Claim 29, Mikhail teaches a system for monitoring an internally fixated bone fracture through the use of strain sensors (see abstract; Fig. 2). Mikhail teaches a system for monitoring strain on a musculoskeletal element of a patient having an injury at an injury location (see abstract, ¶[0027]-[0028] the monitoring of a bone fracture utilizing strain gauges; Fig. 2),
arranged to perform monitoring at least once a week, over a period of at least 12 weeks, or at least 12 times (¶[0055] the measurements may occur more than once a week), the system comprising:
an implantable load-bearing fixation and sensing device comprising: an elongate implantable reinforcement structure (¶[0022] and [0025]-[0026] the bone plate 12; Fig. 2);
a deformation sensing arrangement physically coupled to the reinforcement structure to be at least partially implanted in the patient, the deformation sensing arrangement configured to sense strain along the elongate implantable reinforcement structure (¶[0026]-[0028] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location; Fig. 2);
a power supply arrangement configured to provide power to the deformation sensing arrangement (¶[0030] the power device 66; Fig. 2);
a short-range wireless transceiver configured to communicate digital data using a first protocol (¶[0028] the antenna 64, ¶[0031]-[0034] the wireless communication may be implemented through RFID, NFC, or BLE; Fig. 2); and
a processor configured to control the power supply arrangement to power the deformation sensing arrangement (¶[0028]-[0029] the communication circuitry 62; Fig. 2),
to obtain a measurements from the plurality of sensors to derive from the plurality of measurements a measure indicative of deformation associated with stress or movement in the vicinity of the injury location (¶[0026] the primary load sensor 52 senses the load carried by the plate 12 at the fracture 50, and the at least one reference load sensor 54 senses load carried by the plate 12 at location(s) spaced from the fracture 50, ¶[0028]-[0029] the communication circuitry 62 may receive and store measurements from the sensor; Fig. 2),
to communicate via the short range wireless transceiver to an external user device, to receive a first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement and to transmit a second signal based on said measure to the external user device (¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor; Figs. 3-6);
the external user device (the reading device 42 and the portable computing device 72; Fig. 3) comprising:
a first communication interface configured when positioned externally of the patient to send the first signal to trigger the processor to power the deformation sensing arrangement and obtain the measure indicative of deformation in the vicinity of the injury location, and to receive the second signal using the first protocol (see ¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, may send a signal to start the measurement via user device 72, the portable computing device 72 may receive data from the implanted sensor, ¶[0031]-[0034] the wireless communication may be implemented through RFID, NFC, or BLE; Figs. 3-6);
a second communication interface configured to communicate measurement data based on the second signal to a remote server (¶[0022]-[0023] the data server receives patient data 24 through the use of the user device 72, data is sent over the internet through local or wide area networks, ¶[0034] communications may utilize Wi-Fi); and
at least one alerting device configured to provide an audible and/or visual alert to a user to indicate that the patient should adopt the predetermined pose (¶[0038] the display 88 of the user device for providing visual cues to the patient; Fig. 5);
wherein the external user device is configured to determine whether the patient has adopted the predetermined pose using one or more sensors and/or one or more indications from the user that the patient has adopted the predetermined pose (¶[0039]-[0040] the portable computing device 72 receives the indication 114 to start measurement, the processor 80 may instruct user on how to position their body for measurement, the position may be confirmed via actuation of a button by the user and/or automatically through orientation data acquired from an accelerometer or an inertial measurement unit; Fig. 5) and
wherein the first communication interface is configured to send the first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement once the patient has adopted the predetermined pose (see ¶[0040]-[0041] once the indication is received, the antenna is energized, once the user’s position is verified, the measurement data is received).
Mikhail is silent regarding the deformation sensing arrangement comprises a single multimodal optical fiber having a plurality of Bragg gratings configured to sense strain, each of the Bragg gratings fixed to the reinforcement structure at a respective location spaced along a length of the multimodal optical fiber and configured to reflect light with a different range of wavelengths, each location being indicated by the particular range of wavelengths being reflected by the particular Bragg grating located at that particular location, the single multimodal optical fiber having at least one further Bragg grating configured to sense temperature.
Buescher teaches a bone healing monitoring system with an implantable and biocompatible optical fiber (see abstract and ¶[0006]-[0007] and ¶[0067]-[0069]; Figs. 1 and 6A); the optical fiber itself may be implanted (see ¶[0047] the sleeve may be attached to bone, the optical fiber inside the sleeve, ¶[0048] the optical fiber itself may be attached to bone; Figs. 3A, 4A, and 5A); and that the optical fiber may be attached to a bone plate via adhesive (see ¶[0061]-[0062]). Buescher teaches a single multimodal optical fiber having a plurality of Bragg gratings spaced along a length of the multimodal optical fiber (¶[0035]-[0036] the optical fiber 20 includes Bragg mirror sensors 26 along the length of the optical fiber; Fig. 1),
the plurality of Bragg gratings being configured to sense strain (¶[0008], ¶[0018], ¶[0036], and ¶[0041] the Bragg mirror sensors are capable of measuring strain; Fig. 6A),
each Bragg grating of the plurality of Bragg gratings being configured to reflect light with a different range of wavelengths (¶[0008] and ¶[0035]-[0036] each Bragg mirror sensor may be tuned to a different bandwidth of light, so that the multiplex signal from the plurality of sensors may be demuxed by a processor),
the single multimodal optical fiber having at least one further Bragg grating configured to sense temperature (¶[0008], ¶[0018], ¶[0036], and ¶[0041] the Bragg mirror sensors are capable of measuring temperature, an embodiment with a plurality of strain Bragg mirror sensors and one temperature Bragg mirror sensor is possible).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the optical fiber strain and temperature sensors of Buescher as the strain sensors of Mikhail because (1) it is the simple substitution of one known element for another to obtain predictable results and/or (2) the sensing arrangement of strain and temperature measurements of Buescher helps to monitor for complications as a wound heals (see Buescher ¶[0002]-[0007]). Here, the modified Mikhail teaches that the Bragg gratings would occupy the locations of the load sensor 52 sense at the plate 12 at the fracture 50, and the at least one reference load sensor 54 at location(s) at the plate 12 spaced from the fracture 50.
The modified Mikhail teaches circuitry on the implant device (see ¶[0028]-[0029]); however, the modified Mikhail does not specifically teach that the sensor is supplied power selectively.
Windolf teaches a device for affixing to an implant with an included strain sensor (see abstract; Fig. 1). Windolf teaches only collecting measurements when movement is detected (see ¶[0041]) or based on a schedule (see ¶[0047]) for the purpose of energy savings. This reads on the broadest reasonable interpretation (BRI) of power supplied selectively (see specification pg. 4, ¶2, the measuring only when required).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the selective power logic of Windolf with the modified Mikhail because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) only measuring when necessary would save energy (see Windolf ¶[0041]).
Regarding Claim 30, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. The modified Mikhail further teaches processing logic for selectively determining a representative measure of strain in the elongate implantable reinforcement structure in the vicinity of the injury location (see Mikhail ¶[0005]-[0007] and ¶[0026], the reference load/strain sensor 54 vs the primary load/strain sensor 52, the primary sensor 41 corresponds to the injury, and the reference is spaced apart from the injury, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location, Fig. 2; see Buescher ¶[0008], ¶[0018], ¶[0036], and ¶[0041], the Bragg mirror sensors are capable of measuring strain, ¶[0036] the multiplex signal sent back from multiple sensors may be demuxed by a processor, Fig. 6A).
Regarding Claim 32, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the audible and/or visual alert to the user comprises at least one of a textual and/or audio instruction, a graphic, an animation, a light, or a sound (see ¶[0038], the visual cues; Fig. 5).
Regarding Claim 33, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. The modified Mikhail further teaches the musculoskeletal element is a fractured internal bone (see Mikhail abstract and ¶[0004]-[0005] the system is for monitoring a fracture in a bone, it is an implantable fixation device; Fig. 2),
wherein the implantable load-bearing fixation and sensing device is encapsulated in a biocompatible housing or coating (see Mikhail ¶[0031] for the incorporated reference US Patent Application Publication 2019/0038214, ¶[0076] the cover for the sensor is a biocompatible material, there is no modification of Mikhail, as the sensors of Mikhail are designed for in vivo use; see Buescher ¶[0006] the optical fiber is biocompatible, ¶[0047]-[0048] the optical fiber is designed for in vivo use), and
wherein the implantable reinforcement structure is an implantable bone reinforcement structure fully implanted in the patient (see abstract and ¶[0004]-[0005] the system is for monitoring a fracture in a bone, it is an implantable fixation device, Fig. 2; see Buescher abstract, ¶[0006], and ¶[0047]-[0048] the optical fiber is implantable).
Regarding Claim 34, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the external user device is provided by an application running on a mobile device (see ¶[0033], the portable computing device 72; Fig. 3).
Regarding Claim 35, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the first communication interface is configured to use a short range wireless communication protocol (see ¶[0031]-[0034], the wireless communication may be implemented through RFID, NFC, or BLE); and
the second communication interface is configured to use a wireless, wired or mobile, local area or wide area communication protocol (see ¶[0022]-[0023], the data server receives the patient data 24 through the use of the user device 72, which is sent out over the internet through local or wide area network, ¶[0034] wireless communications may include Wi-Fi); and
the remote server is configured to communicate with the external user device using the wireless, wired or mobile, local area or wide area communication protocol (see ¶[0022]-[0023] the data server receives the patient data 24 through the use of the user device 72, which is sent out over the internet through local or wide area network, ¶[0034] wireless communications may include Wi-Fi).
Regarding Claim 36, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the power supply arrangement is arranged to receive power from an external power source (¶[0030] the energy source may include wireless charging via radio waves, ¶[0033] the power transmission circuitry 78 may include inductive charging, ¶[0040] the antenna 70 is energized via the power transmission circuitry 78, the antenna 70 energizes the sensors 52/54; Fig. 4).
Regarding Claim 37, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the power supply arrangement comprises a battery (see ¶[0031] for the incorporated reference US Patent Application Publication 2019/0038214, ¶[0038] the sensor may comprise a power device 106, which may be a battery; Figs. 2 and 7).
Regarding Claim 39, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. Mikhail further teaches the remote server is configured to determine a healing condition of the injury based on the measurement data by comparing the measurement data with one or more thresholds and/or one or more reference signals (¶[0049] a trendline 146 of a patient’s healing progress over time may be constructed, ¶[0051] the trajectory range 158 of the patient’s trendline 146 may be constructed based off of qualitative/quantitate data from the patient’s medical record, and empirical data taken from prior patients, determined via the data server 20).
Regarding Claim 40, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. The modified Mikhail further teaches the deformation sensing arrangement is physically coupled to the reinforcement structure using an adhesive (see Buescher ¶[0062] the optical fiber may be attached to a bone plate via adhesive) and wherein the adhesive provides a housing or coating (the adhesive placed on the bone plate would be considered a coating). Here, the context to which the adhesive is used in Buescher suggests that the adhesive itself is biocompatible. Otherwise, it would not have been in use in the in vivo application of Buescher (see ¶[0047] and ¶[0061]-[0062]) and in the manner disclosed in Buescher. Thus, one of ordinary skill in the art would have understood the adhesive of Buescher would have been biocompatible.
Regarding Claim 42, Mikhail in view of Buescher and Windolf teaches the system of claim 29 as stated above. The modified Mikhail further teaches a method for monitoring strain on an internal bone of a patient at least once a week, over a period of at least 12 weeks, or at least 12 times (see Mikhail ¶[0055] the measurements can occur more than once a week),
using the system of claim 29 (see Mikhail, Buescher, and Windolf in claim 29 above), the method comprising:
providing on the at least one alerting device an audible and/or visual alert to the user to indicate that the patient should adopt a predetermined pose (see Mikhail ¶[0038], the display 88 of the user device for providing visual cues to the patient; Fig. 5);
determining, by the external user device, whether the patient has adopted the predetermined pose using one or more sensors and/or one or more indications from the user that the patient has adopted the predetermined pose (see Mikhail ¶[0039]-[0040], the portable computing device 72 receives the indication 114 to start measurement, the processor 80 may instruct user on how to position their body for measurement, the position may be confirmed via actuation of a button by the user and/or automatically through orientation data acquired from an accelerometer or an inertial measurement unit; Fig. 5);
wirelessly transmitting, via the first communication interface of the external user device to the implantable load-bearing fixation and sensing device, the first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement once the patient has adopted the predetermined pose (see Mikhail ¶[0032]-[0040], the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor; Figs. 3-6);
receiving the first signal at the implantable load-bearing fixation and sensing device and, in response, controlling the power supply arrangement to power the deformation sensing arrangement (see Mikhail ¶[0040]-[0041], once the indication is received, the antenna is energized, once the user’s position is verified, the measurement data is received);
deriving, using the deformation sensing arrangement, a measurement indicative of strain of the implantable reinforcement structure (see Mikhail ¶[0005]-[0007] and ¶[0026], the reference load/strain sensor 54 vs the primary load/strain sensor 52, the primary sensor 41 corresponds to the injury, and the reference is spaced apart from the injury, the load sensors 52/54 may include a strain gauge 60, that has an electrical property that varies in an established manner with an amount of strain experienced by the gauge/plate at that location, Fig. 2; see Buescher ¶[0008], ¶[0018], ¶[0036], and ¶[0041], the Bragg mirror sensors are capable of measuring strain, ¶[0036] the multiplex signal sent back from multiple sensors may be demuxed by a processor, Fig. 6A);
wirelessly transmitting a signal encoding said derived measurement from the processor to the first communication interface of the external user device (see Mikhail ¶[0032]-[0040], the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor; Figs. 3-6);
communicating measurement data based on the derived measurement from the second interface of the external user device to a-the remote server (see Mikhail ¶[0022]-[0023], the data server receives patient data 24 through the use of the user device 72, data is sent over the internet through local or wide area networks, ¶[0034] the communications can utilize Wi-Fi).
Regarding Claim 43, Mikhail in view of Buescher and Windolf teaches the method of claim 42 as stated above. Mikhail further teaches determining, by the remote server, a healing condition of the fracture based on the measurement data (¶[0009]-[0010], the healing trajectory, ¶[0049]-[0053] the healing trajectory 158 may be determined through statistics/machine learning via the data server 20; Fig. 7);
determining a second pose for the patient to adopt (¶[0040] and ¶[0045]-[0047] the second posture may be considered the load-bearing position/posture);
sending instructions on the second pose (¶[0038] the visual cues, the load-bearing measurement 98; Fig. 5); and
updating, by the external user device, the audible and/or visual alert such that it indicates that the patient should adopt the second pose (¶[0038] the visual cues, the load-bearing measurement 98; Fig. 5);
wherein wirelessly transmitting the first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement is performed once the patient has adopted the second pose (¶[0041] the measurements are performed once the confirmation that the user is in position is received, ¶[0047] the measurements are performed once it is determined that enough load is applied to the bone).
The modified Mikhail teaches determining a second pose for the patient to adopt, but not specifically that the remote server performs this determination based on the healing condition, and the remote server subsequently sending instructions based on the determination.
Here, Mikhail teaches updating the healing prediction over time as measurements are recorded, and contemplates utilizing such data for providing guidance on recommended physical therapy treatment (see ¶[0052]). The specification of the present application details that updating the pose can include making sure that enough load is being applied to the sensor in that pose (see specification pg. 13, ¶2-3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine if enough load has been applied during the second, load-bearing posture, utilizing the server implemented machine learning model and healing data because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) determining if enough load is present would indicate that the measurements are accurate/useful in the evaluation of the healing of the injury.
Furthermore, the BRI of the present claim for the recitation of “pose” would include performing a particular exercise or activity, which cycles through multiple poses (see specification pg. 5, ¶4). Mikhail teaches that the server can recommend physical therapy treatment based on the measurements, through the server implemented machine learning model. And, because physical therapy reads upon a particular exercise or activity which cycles through multiple poses, Mikhail therefore teaches determining a second pose based off of the healing data. In this situation, the first pose would be considered the non-load/load bearing poses; and the second pose would be considered the recommended physical therapy treatment.
Regarding Claim 44, Mikhail in view of Buescher and Windolf teaches the method of claim 43 as stated above. Mikhail further teaches determining the healing condition comprises the remote server (see ¶[0051] machine learning model implemented through data server 20):
training a learning engine using a training dataset (see ¶[0051] machine learning model is trained with experiential evidence drawn from prior patients, may be supervised or unsupervised learning);
providing input data including the measurement data to the learning engine (¶[0051]-[0052] the patient’s healing progress, most recent measurement, and qualitative/quantitative data entered into machine learning model); and
receiving as output from the learning engine the healing condition, which may be as a classification or a value indicative of treatment progress (¶[0051]-[0052] the healing trajectory 150/158).
Regarding Claim 46, Mikhail in view of Buescher and Windolf teaches the system of claim 39 as stated above. Mikhail further teaches the remote server comprises a learning engine trained using a training dataset (see ¶[0051], machine learning model is trained with experiential evidence drawn from prior patients, may be supervised or unsupervised learning),
the learning engine configured to receive input data including the measurement data (¶[0051]-[0052] the patient’s healing progress, most recent measurement, and qualitative/quantitative data entered into machine learning model), and
to provide as output the healing condition (¶[0051]-[0052] the healing trajectory 150/158).
Regarding Claim 47, Mikhail in view of Buescher and Windolf teaches the modified system of claim 39 as stated above. Mikhail further teaches the remote server is configured to transmit the healing condition to the external user device (¶[0053] healing trajectory 158 may be displayed to patient on display 88, see Fig. 1 the portable device 72 and server 22 can transmit/receive signals to one another), and
wherein the external user device is configured to update the audible and/or visual alert such that it indicates that the patient should adopt a second pose (¶[0040] and [0045]-[0047] the second posture may be considered the load-bearing position/posture, ¶[0038] the visual cues, the load-bearing measurement 98; Fig. 5),
wherein the first communication interface is configured to send the first signal to trigger the processor to control the power supply arrangement to power the deformation sensing arrangement once the patient has adopted the second pose (¶[0041] the measurements are performed once the confirmation that the user is in position is received, ¶[0047] the measurements are performed once it is determined that enough load is applied to the bone).
The modified Mikhail teaches determining a second pose for the patient to adopt, but not specifically that second pose is determined based off of the healing condition.
Here, Mikhail teaches updating the healing prediction over time as measurements are recorded, and contemplates utilizing such data for providing guidance on recommended physical therapy treatment (see ¶[0052]). The specification of the present application details that updating the pose can include making sure that enough load is being applied to the sensor in that pose (see specification pg. 13, ¶2-3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine if enough load has been applied during the second, load-bearing posture, utilizing the healing data because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) determining if enough load is present would indicate that the measurements are accurate/useful in the evaluation of the healing of the injury.
Furthermore, the BRI of the present claim for the recitation of “pose” would include performing a particular exercise or activity, which cycles through multiple poses (see specification pg. 5, ¶4). Mikhail teaches that the server can recommend physical therapy treatment based on the measurements, through the server implemented machine learning model. And, because physical therapy reads upon a particular exercise or activity which cycles through multiple poses, Mikhail therefore teaches determining a second pose based off of the healing data. In this situation, the first pose would be considered the non-load/load bearing poses; and the second pose would be considered the recommended physical therapy treatment.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher and Windolf as applied to claim 29 above, and further in view of Edmund Optics Worldwide (“Photonic-electronic integrated circuits”, Edmund Optics Inc., published on September 05, 2018, published at www.edmundoptics.com/knowledge-center/trending-in-optics/photonic-electronic-integrated-circuits/), hereinafter Edmund.
Regarding Claim 31, Mikhail in view of Buescher and Windolf teach the system of claim 29 as stated above. Mikhail teaches utilizing integrated circuits for the components of the implanted sensor (see Mikhail ¶[0031] incorporated reference US Patent Application Publication 2019/0038214, ¶[0039] the integrated circuit); but does not specifically teach that the circuit is a photonic integrated circuit.
Edmund teaches about photonic integrated circuits, including their use for medical devices (see pg. 1-2).
Accordingly, it would have been obvious to utilize the photonic integrated circuit of Edmund as the integrated circuit of the modified system of Mikhail because photonic integrated circuits provide higher speeds, greater bandwidth, and lower energy loss over conventional circuits (see Edmund pg. 1).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher and Windolf as applied to claim 29 above, and further in view of Puttlitz et al. (US Patent Application Publication 2019/0162606), hereinafter Puttlitz.
Regarding Claim 38, Mikhail in view of Buescher and Windolf teach the system of claim 29 as stated above. Mikhail further teaches the processor is configured to control the power supply arrangement to power the deformation sensing arrangement (¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, the wireless reader 42 may send a signal to start the measurement via a portable computing device 72, the portable computing device 72 may receive data from the implanted sensor; Figs. 3-6) and create a log of readings in a memory (¶[0008] and ¶[0022] the storage of measurements in memory), and
wherein the processor is configured to transmit the log of readings upon receiving a request from the external user device (¶[0032]-[0040] the wireless reader 42 interacts with the implanted sensor, may send a signal to start the measurement via user device 72, the portable computing device 72 may receive data from the implanted sensor, ¶[0031]-[0034] the wireless communication may be implemented through RFID, NFC, or BLE, ¶[0022]-[0023] the data server receives patient data 24 through the use of the user device 72, data is sent over the internet through local or wide area networks, ¶[0034] communications may utilize Wi-Fi).
The modified Mikhail does not provide specific limits on the timing of the energizing of the deformation sensing arrangement for measurements, specifically that the power supply arrangement is configured to provide power to the deformation sensing arrangement for a predetermined length of time of no more than 10 ms for each measurement. However, the duration of powering the deformation sensing arrangement is parameter that would have been optimized based on the time needed to make a measurement, or desired performance. As such, the duration of powering the deformation sensing arrangement is a results-effective variable that would have been optimized through routine experimentation based on the time needed to make a measurement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to power the deformation sensing arrangement for a duration so that it may make a measurement as required by the system. Thus, the power supply arrangement configured to provide power to the deformation sensing arrangement for a predetermined length of time of no more than 10 ms for each measurement would have been obvious.
The modified Mikhail is silent regarding the processor is configured to power up the sensor at predetermined intervals and create a log of readings.
Puttlitz teaches measuring the strain of off a structural member with an antenna spaced from the structural member, such as a target object is deformed, so that deformation is recorded from the structural member and is output via the antenna (see abstract; Figs. 1-3). Puttlitz teaches performing measurements at predetermined intervals (see ¶[0054]; Fig. 8), including the storage of associated data (see ¶[0017]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the performance of measurements at predetermined interval logic of Puttlitz with the modified system of Mikhail because (1) it is the application of a known technique with a known device ready for improvement to yield predictable results and/or (2) recording measurements at predetermined intervals can help the user plan for and remember to perform measurements.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher and Windolf as applied to claim 29 above, and further in view of Luna Innovations, previously Micron Optics (“Grating Based Temperature Sensors – Temperature Calibration and Thermal Response”, 11/2008, published at lunainc.com/sites/default/files/assets/files/resource-library/TemperatureCalibration-FBGSensors-r2.pdf), hereinafter Luna.
Regarding Claim 41, Mikhail in view of Buescher and Windolf teach the system of claim 29 as stated above. The modified Mikhail teaches that the at least one further Bragg grating is capable of measuring temperature (see Buescher ¶[0008], ¶[0018], ¶[0036], and ¶[0041]), but not specifically what temperature range that these sensors are capable of measuring.
Luna teaches about the importance of calibrating fiber Bragg grating (FBG) temperature sensors (see pg. 1 ¶1-2), and that FBG temperature sensors can measure in a range of -40 ºC to 120 ºC or -200 ºC to 275 ºC (see pg.4-5 § Calibration Technique); in which, either temperature range covers the claimed recitation of around 25 ºC to 50 ºC.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the FBG temperature sensors of Luna with the modified system of Mikhail because (1) it is the simple substitution of one known element for another to obtain predictable results and/or (2) calibrated FBG temperature sensors provide accurate temperature measurements over a wide temperature range (see Luna pg. 1 ¶2).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Mikhail in view of Buescher and Windolf as applied to claim 36 above, and further in view of Hannan et al. (“Energy harvesting for the implantable biomedical devices: issues and challenges”, Biomedical Engineering OnLine, 13:79, published June 20, 2014).
Regarding Claim 45, Mikhail in view of Buescher and Windolf teach the modified system of claim 36 as stated above. Mikhail further teaches a capacitor configured to charge inductively using an energetic signal from the external power source (¶[0033] the power transmission circuitry 78 can include inductive charging, ¶[0040] the antenna 70 is energized via the power transmission circuitry 78, the antenna 70 energizes the sensors 52/54, Fig. 4; see ¶[0031] for the incorporated reference US Patent Application Publication 2019/0038214, ¶[0038] and ¶[0058] the sensor may comprise a power device 106 which may charge a capacitor),
wherein the energetic signal is a radio-frequency signal (¶[0030] the energy source can include wireless charging via radio waves).
The modified Mikhail does not provide specific limits on charging, specifically the energetic signal has a power of around 500 µW or less and is transmitted for a duration of around 2 seconds or less.
Hannan teaches about the harvesting of energy via different means and sources for implanted medical devices (see abstract). Hannan teaches for inductive energy harvesting, RF waves may be harvested at low power (less than a milliwatt) at frequencies below 20 MHz to avoid tissue heating, utilizing capacitors in the receiving circuit (see pg.10-12 § Inductive energy harvesting).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the RF signal energy harvesting scheme of Hannan with the modified system of Mikhail because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) utilizing charging at the power of Hannan would avoid tissue heating (see Hannan pg. 10 § Inductive energy harvesting ¶1).
Further, the amounted of time for recharging will depend upon the amount of charging required and the rate of charging. Accordingly, the amount of power and transmission duration are parameters that would have been optimized based on the power requirements of the sensors needed in order to make measurements, the amount of charging required and the rate of charging, and desired performance. As such, the power and transmission duration are results-effective variables that would have been optimized through routine experimentation based on the power requirements of the sensors needed to take measurements, the amount of charging required and the rate of charging, and desired performance. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to give the energetic signal an appropriate power and transmission duration so that the sensors may make their measurements as required by the system. Thus, the energetic signal having a power of around 500 µW or less and is transmitted for a duration of around 2 seconds or less would have been obvious.
Conclusion
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791