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 .
Response to Amendment
The amendment filed on February 02, 2026 was considered by the examiner. Claims 1 and 3-20 are pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities:
in claim 1, lines 12-13: “a data signal including the sensor data and” should be “a data signal, including the sensor data, and”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a wireless transceiver configured to transmit a data signal including the sensor data and-receive data-signals” in lines 12-13; however, the only element disclosed with respect to the prosthetic implant is the wireless communication device, which is configured for communicating using an IEEE 802.15.6-2012 protocol, a Medical Implant Communication Service (MICS) protocol, or a Medical Body Area Networks (MBANs) protocol (see specification ¶[0099]-[0100]). However, no structure is provided for the wireless communication device such that there is no basis in the written description for a wireless transceiver of the prosthetic implant. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claim 1 recites “a wireless transceiver configured to receive the data signal and transmit data signals to the wireless transceiver of the prosthetic implant” in lines 19-20; however, the only element disclosed with respect to the external interrogation device is the wireless communication signal generator, which is configured for exchanging data with the wireless communication device (see specification ¶[0099]-[0100]). However, no structure is provided for the wireless communication signal generator such that there is no basis in the written description for a wireless transceiver of the external interrogation device. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claims 3-9 are rejected by virtue of their dependence from claim 1.
Claim 10 recites “a wireless transceiver configured to generate a low-power, human anatomy compatible communication signal” in lines 8-9; however, the only element disclosed with respect to the external interrogation device is the wireless communication signal generator, which is configured for exchanging data with the wireless communication device (see specification ¶[0099]-[0100]). However, no structure is provided for the wireless communication signal generator such that there is no basis in the written description for a wireless transceiver of the external interrogation device, including when the external interrogation device is a home base station. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claim 11 is rejected by virtue of its dependence from claim 10.
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, 3-11, and 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a data signal” in line 12, “data signals” in line 13, “the data signal” in line 19, and “data signals” in line 19; however, the relationship between these recitations are not clear. It appears as if the recitations “a data signal” in line 12 and “the data signal” in line 19 are the same. The additional recitations of “data signals” in lines 13 and 19 add confusion to the recitations that appear to be the same. Are the singular recitations part of or excluded from the plural “data signals”? Are the two recitations of “data signals” the same, related, or different? The lack of a definite article “the” on the second plural recitation in line 19 adds confusion to this. Appropriate clarification is required.
Claims 3-9 are rejected by virtue of their dependence from claim 1.
Claim 5 recites “a radio frequency energy harvester” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a radio frequency energy harvester” in claim 1, line 9. The similar phraseology suggest that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the radio frequency energy harvester”. If the recitations are different, the relationship between these 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). For the purposes of examination, the recitations are being interpreted as the same. Furthermore, it appears this recitation is a duplicate of that in claim 1, and this recitation should be deleted.
Claim 5 recites “a radio frequency signal generator” in line 3, but it is not clear if this recitation is the same as, related to, or different from the recitation “a radio frequency signal generator” in claim 1, line 15. The similar phraseology suggest that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the radio frequency signal generator”. If the recitations are different, the relationship between these 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). For the purposes of examination, the recitations are being interpreted as the same. Furthermore, it appears this recitation is a duplicate of that in claim 1, and this recitation should be deleted.
Claim 6 is rejected by virtue of its dependence from claim 5.
Claim 6 recites “a capacitor” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a capacitor” in claim 1, line 10. The similar phraseology suggest that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the capacitor”. If the recitations are different, the relationship between these 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). For the purposes of examination, the recitations are being interpreted as the same. Furthermore, it appears this recitation is a duplicate of that in claim 1, and this recitation should be deleted.
Claim 9 recites “a radio frequency energy harvester” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a radio frequency energy harvester” in claim 1, line 9. The similar phraseology suggest that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the radio frequency energy harvester”. If the recitations are different, the relationship between these 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). For the purposes of examination, the recitations are being interpreted as the same. Furthermore, it appears this recitation is a duplicate of that in claim 1, and this recitation should be deleted.
Claim 9 recites “the wireless power signal generator is configured to generate a radio frequency signal” in line 4; however, claim 1, lines 15-16 indicates that “a radio frequency generator configured to generate a radio frequency signal”. It appears as if this recitation is a duplicate/is related to the recitation of claim 1, and this recitation should be deleted. It is also not clear the relationship between the two recitations of “a radio frequency signal”.
Claim 10 recites “for transmitting and receiving data with the medical implant sensor device” in lines 9-10, which is grammatically awkward and generally unclear. It is not clear which positively recited claim element is performing this function; as the element appears to be tied to the “low-power, human anatomy compatible communication signal”, which is not a structural element for facilitating communication, including “for transmitting and receiving data”. Appropriate clarification is required.
Claim 11 is rejected by virtue of its dependence from claim 10.
Claim 15 recites “wherein generating the wireless powering signal comprises generating an inductive charging signal” in lines 1-2; however, claim 12 recites “the wireless powering signal comprising a radio frequency signal” in line 4. It is not clear which signal is actually generated or what the wireless powering signal actually comprises. This inconsistency renders claim 15 indefinite. For the purposes of examination, the wireless powering signal is interpreted to cover the radio frequency signal as recited in claim 12.
Claim 16 recites “a radio frequency signal” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a radio frequency signal” in claim 12, line 4. The similar phraseology suggest that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the radio frequency energy harvester”. If the recitations are different, the relationship between these 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). For the purposes of examination, the recitations are being interpreted as the same. Furthermore, it appears this recitation is a duplicate of that in claim 12, and this recitation should be deleted.
Claims 17-20 are rejected by virtue of their dependence from claim 16.
Claim 17 recites “the wireless powering signal is generated using a dongle connectable to an internet router” in lines 1-2; however, claim 12 recites “generating a wireless powering signal with an external interrogation device comprising a home base station”. It is not clear which device (i.e., the home base station or the dongle) is generating the wireless powering signal. This inconsistency renders claim 17 indefinite. For the purposes of examination, the wireless powering signal is interpreted to be generated by the home base station as recited in claim 12.
Claim 18 recites “power” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “electrical power” in claim 12, line 8. The similar phraseology suggest that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the electrical power”. If the recitations are different, the relationship between these 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). For the purposes of examination, the recitations are being interpreted as the same. Furthermore, it appears this recitation is a duplicate of that in claim 12, and this recitation should be deleted.
Claim 18 recites “an RF energy harvester” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a radio frequency energy harvester” in claim 12, line 7. The similar phraseology suggest that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the radio frequency energy harvester”. If the recitations are different, the relationship between these 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). For the purposes of examination, the recitations are being interpreted as the same. Furthermore, it appears this recitation is a duplicate of that in claim 12, and this recitation should be deleted.
Claim 19 recites “power” in line 1, but it is not clear if this recitation is the same as, related to, or different from the recitation “electrical power” in claim 12, line 8. The similar phraseology suggest that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the electrical power”. If the recitations are different, the relationship between these 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). For the purposes of examination, the recitations are being interpreted as the same.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-6 and 16-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 5 recites “the internal power device comprises a radio frequency energy harvester; and the wireless power signal generator comprises a radio frequency signal generator” in lines 2-3. However, such elements are now present in amended claim 1. Therefore, claim 5 does not further limit the subject matter of independent claim 1. Claim 5 should be canceled.
Claim 6 is rejected by virtue of its dependence from claim 5.
Claim 6 recites “the internal power device comprises a capacitor to store energy generated by the radio frequency energy harvester” in lines 1-2. However, such elements are now present in amended claim 1. Therefore, claim 6 does not further limit the subject matter of independent claim 1. Claim 6 should be canceled.
Claim 16 recites “generating the wireless powering signal comprises generating a radio frequency signal” in lines 1-2. However, such elements are now present in amended claim 12. Therefore, claim 16 does not further limit the subject matter of independent claim 12. Claim 16 should be canceled.
Claims 17-20 are rejected by virtue of their dependence from claim 16.
Claim 18 recites “activating the sensor device with the wireless powering signal comprises generating power with an RF energy harvester” in lines 1-2. However, such elements are now present in amended claim 12. Therefore, claim 18 does not further limit the subject matter of independent claim 12. Claim 18 should be canceled.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The succeeding art rejections to the claims under 35 U.S.C. § 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 1, 3-7, 10, 12, 14-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrante et al. (US Patent Application Publication 2022/0160301 – cited in prior action), hereinafter Ferrante, and in view of Routh et al. (US Patent Application Publication 2019/0380628), hereinafter Routh.
Regarding Claim 1, Ferrante teaches a medical implant device, such as an intramedullary nail, including an energy harvesting sensor, such as a strain sensor, and telemetry system (see abstract; Figs. 1-2). Ferrante teaches a surgical sensor system for collecting internal patient data (see abstract; Figs. 1-2), the surgical sensor system comprising:
a prosthetic implant (¶[0061]-[0063] the medical implant device 160, such as tibial tray; Figs. 1-2) comprising:
a housing (¶[0123]-[0126] the housing of the cap 940 about the cavity 912, ¶[0127]-[0130] the pocket 1011 formed within the housing of the implant 1060 itself; Figs. 9A-9B and 10A-10C);
a sensor configured to generate sensor data (¶[0053]-[0054], ¶[0063]-[0065] the PVDF strain sensor 162; Figs. 1-2 and 5) disposed within the housing (¶[0048] and ¶[0128] the sensor may be positioned within the pocket/cavity);
an internal power device connected to the sensor to provide power to the sensor (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2);
wherein the internal power device comprises:
a radio frequency energy harvester (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2); and
a capacitor to store energy generated by the radio frequency energy harvester (¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220; Figs. 1-2); and
a wireless transceiver configured to transmit a data signal including the sensor data and receive data signals (¶[0071]-[0072] the telemetry device 250 for communicating with the external computing device; Figs. 1-2 and 5);
an external interrogation device (¶[0047]-[0048], ¶[0071], and ¶[0109] the remote device, such as computing device 110/520; Figs. 1-2 and 5) comprising:
a wireless power signal generator comprising a radio frequency signal generator configured to generate a radio frequency signal for activating the internal power device of the prosthetic implant (¶[0047], ¶[0072], and ¶[0108] the discrete signal monitoring via the external computing device, ¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2),
wherein the radio frequency generator is configured to provide radio frequency coverage throughout a building (¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device, Figs. 1-2; here the claim does not specify a building size, and Ferrante does not specify RF coverage, except that the coverage is sufficient to reach the implanted device, therefore, the RF coverage would be sufficient to cover an extremely small building, which fits the broadest reasonable interpretation (BRI) of the recitation building as presently recited in the claim); and
a wireless transceiver configured to receive the data signal and transmit data signals to the wireless transceiver of the prosthetic implant (¶[0047]-[0048], ¶[0071], and ¶[0109] the remote device, such as computing device 110/520, ¶[0047], ¶[0072], and ¶[0108] the discrete signal monitoring via the external computing device; Figs. 1-2 and 5).
Alternatively and/or additionally, Routh teaches apparatus and methods for blood analyte sensing, data processing, and transmission and storage, via a spatially compact multi-element implantable blood glucose sensor through low-power operation (see abstract and Figs. 1A-1T), in which the wireless transmission may include RF signal transmission (see ¶[0073], ¶[0090], ¶[0128], ¶[0142], and ¶[0149]; Figs 1A, 2F-2J), in which the RF coverage extends through a room/building of two meter surrounding space (see ¶[0052] and Figs. 2I-2J). Here, the two meter surrounding space coverage is interpreted to cover for the building of the present claim, as the size of the building of the present claim is not specified.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to provide RF coverage for two meters surrounding the individual (i.e., a building space coverage as under the BRI of building of the present claim) in Ferrante as taught by the two meter surrounding coverage in Routh because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Ferrante requires RF coverage and Routh teaches one such RF coverage; and/or (3) the two meter surrounding space coverage would provide adequate RF coverage for normal users using an implanted device (see Routh ¶[0128]).
Regarding Claim 3, Ferrante in view of Routh teaches the system of claim 1 as stated above. Ferrante further teaches the wireless transceivers are configured to communicate using a Wireless Body Area Network, a Medical Implant Communication Service (MICS) protocol, or a Medical Body Area Networks (MBANs) protocol (¶[0071] the wireless transmission protocols may include MICS).
Regarding Claim 4, Ferrante in view of Routh teaches the system of claim 1 as stated above. Ferrante further teaches the external interrogation device further comprises a communications interface for the Internet (¶[0162]-[0169] the computer 2302 is capable of connecting to the internet; Figs. 1-2 and 23).
Regarding Claim 5, Ferrante in view of Routh teaches the system of claim 1 as stated above. Ferrante further teaches the internal power device comprises a radio frequency energy harvester; and the wireless power signal generator comprises a radio frequency signal generator (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2).
Regarding Claim 6, Ferrante in view of Routh teaches the system of claim 5 as stated above. Ferrante further teaches the internal power device comprises a capacitor to store energy generated by the radio frequency energy harvester (¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220; Figs. 1-2).
Regarding Claim 7, Ferrante in view of Routh teaches the system of claim 1 as stated above. Ferrante further teaches the internal power device comprises a battery; and the wireless power signal generator comprises a wireless charging signal generator (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2).
Regarding Claim 10, Ferrante teaches a medical implant device, such as an intramedullary nail, including an energy harvesting sensor, such as a strain sensor, and telemetry system (see abstract; Figs. 1-2). Ferrante teaches a medical implant sensor interrogation device comprising: a home base station (see abstract, ¶[0047]-[0048], ¶[0071], and ¶[0109] the remote device, such as computing device 110/520, such devices fall under the BRI of the home base station; Figs. 1-2 and 5) comprising:
a communication interface configured to communicate with the Internet via a wired connection or wireless signal (¶[0162]-[0169] the computer 2302 is capable of connecting to the internet; Figs. 1-2 and 23);
a radio frequency signal generator configured to generate a radio frequency signal to activate a radio frequency energy harvester (¶[0047], ¶[0072], and ¶[0108] the discrete signal monitoring via the external computing device, ¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2)
of a medical implant sensor device (¶[0061]-[0063] the medical implant device 160, such as tibial tray; Figs. 1-2); and
a wireless transceiver configured to generate a low-power, human anatomy compatible communication signal for transmitting and receiving data with the medical implant sensor device (¶[0047]-[0048], ¶[0071], and ¶[0109] the remote device, such as computing device 110/520, ¶[0047], ¶[0072], and ¶[0108] the discrete signal monitoring via the external computing device, ¶[0071] the wireless transmission protocols that are human anatomy compatible, such as MICS; Figs. 1-2 and 5),
wherein the radio frequency signal generator is configured to provide radio frequency signal coverage throughout a building (¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device, Figs. 1-2; here the claim does not specify a building size, and Ferrante does not specify RF coverage, except that the coverage is sufficient to reach the implanted device, therefore, the RF coverage would be sufficient to cover an extremely small building, which fits the broadest reasonable interpretation (BRI) of the recitation building as presently recited in the claim).
Alternatively and/or additionally, Routh teaches apparatus and methods for blood analyte sensing, data processing, and transmission and storage, via a spatially compact multi-element implantable blood glucose sensor through low-power operation (see abstract and Figs. 1A-1T), in which the wireless transmission may include RF signal transmission (see ¶[0073], ¶[0090], ¶[0128], ¶[0142], and ¶[0149]; Figs 1A, 2F-2J), in which the RF coverage extends through a room/building of two meter surrounding space (see ¶[0052] and Figs. 2I-2J). Here, the two meter surrounding space coverage is interpreted to cover for the building of the present claim, as the size of the building of the present claim is not specified.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to provide RF coverage for two meters surrounding the individual (i.e., a building space coverage as under the BRI of building of the present claim) in Ferrante as taught by the two meter surrounding coverage in Routh because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Ferrante requires RF coverage and Routh teaches one such RF coverage; and/or (3) the two meter surrounding space coverage would provide adequate RF coverage for normal users using an implanted device (see Routh ¶[0128]).
Regarding Claim 12, Ferrante teaches a medical implant device, such as an intramedullary nail, including an energy harvesting sensor, such as a strain sensor, and telemetry system (see abstract; Figs. 1-2). Ferrante teaches a method of remotely interacting with a sensor device implanted in anatomy with an orthopedic device (see abstract, ¶[0053]-[0054], ¶[0063]-[0065] the PVDF strain sensor 162; Figs. 1-2 and 5), the method comprising:
generating a wireless powering signal (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2)
with an external interrogation device comprising a home base station (see abstract, ¶[0047]-[0048], ¶[0071], and ¶[0109] the remote device, such as computing device 110/520, such devices fall under the BRI of the home base station; Figs. 1-2 and 5),
the wireless powering signal comprising a radio frequency signal configured to provide coverage through a building (¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device, Figs. 1-2; here the claim does not specify a building size, and Ferrante does not specify RF coverage, except that the coverage is sufficient to reach the implanted device, therefore, the RF coverage would be sufficient to cover an extremely small building, which fits the broadest reasonable interpretation (BRI) of the recitation building as presently recited in the claim);
activating the sensor device with the radio frequency signal of the wireless powering signal using a radio frequency energy harvester within the sensor device to generate electrical power from the radio frequency signal to power the sensor device (¶[0047], ¶[0072], and ¶[0108] the discrete signal monitoring via the external computing device, ¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2);
collecting sensor data from the sensor device with the external interrogation device (¶[0047]-[0048], ¶[0071], and ¶[0109] the remote device, such as computing device 110/520, ¶[0047], ¶[0072], and ¶[0108] the discrete signal monitoring via the external computing device; Figs. 1-2 and 5); and
wirelessly communicating the sensor data from the sensor device using a low-power wireless signal (¶[0047]-[0048], ¶[0071], and ¶[0109] the remote device, such as computing device 110/520, ¶[0047], ¶[0072], and ¶[0108] the discrete signal monitoring via the external computing device, ¶[0071] the wireless transmission protocols that are human anatomy compatible, such as MICS; Figs. 1-2 and 5).
Alternatively and/or additionally, Routh teaches apparatus and methods for blood analyte sensing, data processing, and transmission and storage, via a spatially compact multi-element implantable blood glucose sensor through low-power operation (see abstract and Figs. 1A-1T), in which the wireless transmission may include RF signal transmission (see ¶[0073], ¶[0090], ¶[0128], ¶[0142], and ¶[0149]; Figs 1A, 2F-2J), in which the RF coverage extends through a room/building of two meter surrounding space (see ¶[0052] and Figs. 2I-2J). Here, the two meter surrounding space coverage is interpreted to cover for the building of the present claim, as the size of the building of the present claim is not specified.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to provide RF coverage for two meters surrounding the individual (i.e., a building space coverage as under the BRI of building of the present claim) in Ferrante as taught by the two meter surrounding coverage in Routh because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) Ferrante requires RF coverage and Routh teaches one such RF coverage; and/or (3) the two meter surrounding space coverage would provide adequate RF coverage for normal users using an implanted device (see Routh ¶[0128]).
Regarding Claim 14, Ferrante in view of Routh teaches the method of claim 12 as stated above. Ferrante further teaches the low-power wireless signal comprises generating a signal compliant with a Medical Implant Communication Service (MICS) protocol or a Medical Body Area Networks (MBANs) protocol (¶[0071] the wireless transmission protocols that are human anatomy compatible, such as MICS).
Regarding Claim 15, Ferrante in view of Routh teaches the method of claim 12 as stated above. Ferrante further teaches generating the wireless powering signal comprises generating an inductive charging signal (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2).
Regarding Claim 16, Ferrante in view of Routh teaches the method of claim 12 as stated above. Ferrante further teaches generating the wireless powering signal comprises generating a radio frequency signal (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2).
Regarding Claim 18, Ferrante in view of Routh teaches the method of claim 16 as stated above. Ferrante further teaches activating the sensor device with the wireless powering signal comprises generating power with an RF energy harvester (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2).
Regarding Claim 19, Ferrante in view of Routh teaches the method of claim 18 as stated above. Ferrante further teaches storing power in a capacitor electrically connected to the RF energy harvester (¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220; Figs. 1-2).
Regarding Claim 20, Ferrante in view of Routh teaches the method of claim 18 as stated above. Ferrante further teaches activating the sensor device with ambient RF energy (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF; Figs. 1-2).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ferrante in view of Routh as applied to claim 1 above, and in view of Claypool et al. (US Patent Application Publication 2013/0261758 – cited by Applicant), hereinafter Claypool.
Regarding Claim 8, Ferrante in view of Routh teaches the system of claim 1 as stated above. Ferrante further teaches the sensor comprises at least one of a pressure sensor, an accelerometer and a gyroscope (¶[0053]-[0054], ¶[0063]-[0065] the PVDF strain sensor 162; Figs. 1-2 and 5). Here, the specification of the present application details that the pressure sensor may be implemented as a piezoelectric film sensor (see present application specification ¶[0042]).
Ferrante teaches that the sensor system may be utilized with various types of implants, such as a tibial tray and/or knee implant (see ¶[0062]), but the modified Ferrante does not specifically teach that the prosthetic implant comprises a tibial bearing.
Claypool teaches about a tibial prosthesis including a tibial bearing (see abstract and Figs. 3-4B), in which sensors, such as piezoelectric film sensors, may be incorporated within the tibial bearing (see ¶[0108]-[0111]; Figs. 23A-24).
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 sensor system of the modified Ferrante with a tibial implant including a tibial bearing because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) Ferrante contemplates different orthopedic implants, such as a tibial tray and/or knee implant, and the tibial bearing is one such orthopedic implant.
Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrante in view of Routh as applied to claims 1 and 16 above, respectively, and in view of Govari (US Patent Application Publication 2020/0054214 – cited in prior action), hereinafter Govari.
Regarding Claim 9, Ferrante in view of Routh teaches the system of claim 1 as stated above. Ferrante further teaches the internal power device comprises a radio frequency energy harvester; and the wireless power signal generator is configured to generate a radio frequency signal (¶[0046]-[0048], ¶[0076], and ¶[0092] the energy harvesting for the sensor, ¶[0008] energy harvesting from either applied biomechanical forces or ambient RF, ¶[0058]-[0059] and ¶[0064] energy may be stored on a capacitor 220, ¶[0076] the device may utilize a secondary power supply 240, such as a battery, RF charging, or inductive charging device; Figs. 1-2).
The modified Ferrante is silent regarding that the external interrogation device comprises a dongle configured to plug into a wireless router.
Govari teaches about a sensor and network system to monitor patients (see abstract and Fig. 1), including the usage of RF energy powered sensors (see ¶[0036]) and a local computing device 106, which may be implemented as a USB dongle, which may work with a computer, modem, or router (see ¶[0040]). Here, the specification of the present application details that the dongle is a USB dongle (see present application specification ¶[0069]).
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 sensor system of the modified Ferrante with a tibial implant including a tibial bearing because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the dongle is a cheaper and smaller device (than a computer or smart phone) capable of implementing the processing and network functions of the sensor system; and/or (3) the modified Ferrante teaches an external computer device and Govari teaches one such device.
Regarding Claim 17, Ferrante in view of Routh teaches the method of claim 16 as stated above.
The modified Ferrante is silent regarding that the wireless powering signal is generated using a dongle connectable to an internet router.
Govari teaches about a sensor and network system to monitor patients (see abstract and Fig. 1), including the usage of RF energy powered sensors (see ¶[0036]) and a local computing device 106, which may be implemented as a USB dongle, which may work with a computer, modem, or router (see ¶[0040]). Here, the specification of the present application details that the dongle is a USB dongle (see present application specification ¶[0069]).
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 sensor system of the modified Ferrante with a tibial implant including a tibial bearing because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the dongle is a cheaper and smaller device (than a computer or smart phone) capable of implementing the processing and network functions of the sensor system; and/or (3) the modified Ferrante teaches an external computer device and Govari teaches one such device.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrante in view of Routh as applied to claims 10 and 12 above, respectively, and in view of Radziemski et al. (US Patent Application Publication 2017/0319858 – cited in prior action), hereinafter Radziemski.
Regarding Claim 11, Ferrante in view of Routh teaches the device of claim 10 as stated above.
Ferrante teaches utilizing transmission protocols that are human anatomy compatible (see ¶[0071]) and network communications from the IEEE 802 family (see ¶[0170]), but the modified Ferrante does not specifically teach that the sensor communication device is configured to generate an IEEE 802.15.6-2012 protocol compatible signal.
Radziemski teaches about an implanted medical device for receiving energy delivered through an acoustic energy delivery device (see abstract and Fig. 1), in which IEEE 802.15.6 for Wireless Body Area Network (WBAN) standard compliant wireless communications may be utilized (see ¶[0041]).
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 IEEE 802.15.6 for WBAN standard compliant wireless communication of Radziemski as the wireless communication modality of the device of the modified Ferrante because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Ferrante teaches that an IEEE 802 family wireless modality may be utilized and Radziemski teaches one such wireless communication standard.
Regarding Claim 13, Ferrante in view of Routh teaches the method of claim 12 as stated above.
Ferrante teaches utilizing transmission protocols that are human anatomy compatible (see ¶[0071]) and network communications from the IEEE 802 family (see ¶[0170]), but the modified Ferrante does not specifically teach that the low-power wireless signal comprises generating an IEEE 802.15.6-2012 compliant signal.
Radziemski teaches about an implanted medical device for receiving energy delivered through an acoustic energy delivery device (see abstract and Fig. 1), in which IEEE 802.15.6 for Wireless Body Area Network (WBAN) standard compliant wireless communications may be utilized (see ¶[0041]).
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 IEEE 802.15.6 for WBAN standard compliant wireless communication of Radziemski as the wireless communication modality of the method of the modified Ferrante because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the modified Ferrante teaches that an IEEE 802 family wireless modality may be utilized and Radziemski teaches one such wireless communication standard.
Response to Arguments
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 6, filed February 02, 2026, with respect to the rejections of claims 2-4, 10-11, and 13 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made under 35 U.S.C. § 112 that were necessitated by Applicant’s amendment filed on February 02, 2026.
Applicant’s arguments, prior art
Applicant’s arguments, see pg. 7-14, filed February 02, 2026, with respect to the rejections of claims 1-20 under 35 U.S.C. § 102 and 103 have been fully considered; however, are moot because of the new grounds of rejection as recited above, that were necessitated by Applicant’s amendment filed on February 02, 2026. The new grounds of rejection are made further in view of Routh et al. (US Patent Application Publication 2019/0380628).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
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