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 under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN 202100618690.3, filed on 12/27/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/21/2024 and 02/10/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
[0001]: As written it reads “The present disclosure relates to the field of wireless sensing, particularly to a CFR-PEEK orthopedic implant and a preparation method therefor, and a wireless sensing device”. However, this is the first indication of the term “CFR-PEEK” within the specification, therefore the term should be spelled out to provide clarity.
[0009]: As written it reads “The circuit structure includes a Wheatstone bridge circuit, an ADC module and a Bluetooth module”. However, this is the first indication of the term “ADC” within the specification, therefore, the term should be spelled out to provide clarity.
Appropriate correction is required.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Regarding claim 1, as written it reads “A CFR-PEEK orthopedic implant, comprising a CFR-PEEK matrix and a patterned carbonization layer; wherein the patterned carbonization layer is formed by performing in-situ carbonization of the CFR-PEEK matrix”. However, this is the first indication of the term “CFR-PEEK” in the claims, therefore, the term should be spelled out to provide clarity.
Regarding claim 2, as written it reads “the circuit structure comprises a Wheatstone bridge, an ADC module and a Bluetooth module […]”. However, this is the first indication of the term “ADC” therefore, the term should be spelled out to provide clarity.
Appropriate correction is required.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) 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) 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 limitation(s) is/are: the ADC module and the Bluetooth module in claims 2, 9,and 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. That being said, the ADC module is described in the specification when it states “The circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module and then is transmitted through the Bluetooth module” [0009]; “[…] the amplifying signal needs to be performed with analog-digital conversion through the ADC module 32 to be converted into a digital voltage signal, and then is transmitted out through the Bluetooth module 33” [0030]. Therefore, the examiner is interpreting the ADC module to be an analog-to-digital converter which digitizes and amplifies a signal. Thus, claims 1, 9 and 11 are not subject to further rejection under 35 U.S.C. 112 with respect to the ADC module.
Furthermore, the Bluetooth module is described in the specification when it states “The wireless sensing device further includes a mobile terminal which is used to receive a digital voltage signal transmitted by the Bluetooth module, and convert the digital voltage signal into the resistance signal and display it” [0017]. Therefore, the examiner is interpreting the Bluetooth module to be a circuit which is configured to transmit information/signals wirelessly.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, and 3-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Du, Ya-Wei et al: “Physical modification of polyetheretherketone for orthopedic implants”, Frontiers of Materials Science, Higher Education Press, Beijing, vol. 8, no. 4, 21 October 2014 (2014-10-21), pages 313-324, XP 035410126, ISSN: 2095-025X, DOI: 10:1007/S111706-014-0266-4 “Du”.
Regarding claims 1 and 4, Du teaches “A CFR-PEEK orthopedic implant, comprising a CFR-PEEK matrix and a patterned carbonization layer” (Claim 1) (“Physical modification of polyetheretherketone for orthopedic implants” [Title]; “Polyetheretherketone (PEEK) is regarded as one of the most potential candidates for replacing current implant applications” [Abstract]; “With the carbon fibers mixed, the elastic modulus and tensile strength of carbon fiber reinforced (CFR)-PEEK are much closer to cortical bone than those of pure PEEK (Table 1, [6, 8, 17, 22]). Even more remarkable is that, CFR-PEEK has a low wear rate which will result in few wear particles, and reduce the incidence of osteolysis and prosthetic aseptic loosening [23-24]. […] At the same time, this works also showed that processing methods affected bioactivities by changing the surface roughness, and the injection molded PEEK and CFR-PEEK with smooth surfaces were demonstrated to have high measured values in initial cell adhesion and proliferation tests than those machined ones” [Page 314: 2.1 Carbon fiber reinforced PEEK]. Therefore, Du discloses a CFR-PEEK orthopedic implant, comprising a CFR-PEEK matrix and a patterned carbonization layer.);
“A method for preparing a CFR-PEEK orthopedic implant, comprising: providing a CFR-PEEK matrix” (Claim 4) (“Among, the physical methods have aroused significant attention and been widely used to modify PEEK for orthopedic implants” [Abstract]; “Irradiation treatment is a general concept, which could be further divided into plasma treatment, ultraviolet irradiation, excimer laser irradiation, corona, electron beam, ion beams, neural atom beam techniques, etc. [72-83] […] In addition, irradiation treatments are also conducted as the first step of some chemical modifications of PEEK and other polymers by introducing active functional groups onto the inert surface of PEEK [84-88]” [Page 318: Irradiation treatments: Para. 1]. Therefore, Du discloses a method for preparing a CFR-PEEK orthopedic implant, comprising: providing a CFR-PEEK matrix.); and
“wherein the patterned carbonization layer is formed by performing in-situ carbonization of the CFR-PEEK matrix” (Claim 1); “performing in-situ carbonization of a surface of the CFR-PEEK matrix, to form a patterned carbonization layer” (Claim 4) (See [Page 318: Irradiation treatments: Para. 1]; “This review summarizes current physical modification techniques of PEEK for orthopedic applications, which include composite strategies, surface coating methods and irradiation treatments” [Abstract]; “Excimer laser irradiation can modify the surface properties of PEEK related to the formation of polar and reactive chemical groups on the treated surfaces [97-98]” [Page 319: Excimer laser irradiation: Para. 1]. Therefore, the patterned carbonization layer is formed by performing in-situ carbonization of the CFR-PEEK matrix. Additionally, the method involves performing in-situ carbonization of a surface of the CFR-PEEK matrix, to form a patterned carbonization layer.).
Regarding claims 3 and 5, Du discloses all features of the claimed invention as discussed with respect to claims 1 and 4 above, and Du further teaches “the patterned carbonization layer satisfies at least one of the following conditions: the patterned carbonization layer has a slender strip shape and is used to feed back a mechanical signal; the patterned carbonization layer is a curved connection structure with a plurality of slender lines and is used to feed back a temperature signal; and the patterned carbonization layer is square and is used to feed back a chemical signal” (“By the reinforcing of carbon fibers in PEEK, CFR-PEEK showed excellent biotribological property, making implant a long-term use with less wear” [Page 314, 2.1 Carbon fiber reinforced PEEK, Lines 13-15]; “Reinforced fibers (e.g., glass and carbon fibers) are used to improve the mechanical properties of PEEK and bioactive particles are considered to be used to improve the bioactivity” [Page 314, 2 PEEK composites strategies, Lines 3-6]; “Due to stable chemical and physical properties, good biocompatibility and proper mechanical properties, PEEK and its composites have been increasingly applied on orthopedics. In this review, different physical modification methods have been summarized in terms of improving the bioactivity of PEEK for long-term implantation, in which both mechanical property and bone-implant interface should be considered: 1) Compared with those of metal implants, the mechanical properties of PEEK are suitable for bone replacement. To achieve the most ideal mechanical properties, CFR-PEEK was successfully developed with excellent modulus and biotribological property” [Page 320: Summary and conclusions].
In this case, the since CFR-PEEK shows excellent biotribological properties, mechanical properties and bioactivity (i.e. active, measurable and specific response), the patterned carbonization layer satisfies at least one of the following conditions: the patterned carbonization layer has a slender strip shape and is used to feed back a mechanical signal (i.e. corresponding to a bone for example); the patterned carbonization layer is a curved connection structure with a plurality of slender lines and is used to feed back a temperature signal; and the patterned carbonization layer is square and is used to feed back a chemical signal (i.e. corresponding to the bioactivity of the CFR-PEEK).).
Regarding claim 6, Du discloses all features of the claimed invention as discussed with respect to claim 4 above, and Du further teaches “wherein the in-situ carbonization is performed by laser irradiation” (“Irradiation treatment is a general concept, which could be further divided into plasma treatment, ultraviolet irradiation, excimer laser irradiation, corona, electron beam, ion beams, neural atom beam techniques, etc. [72-83] […] In addition, irradiation treatments are also conducted as the first step of some chemical modifications of PEEK and other polymers by introducing active functional groups onto the inert surface of PEEK [84-88]” [Page 318: Irradiation treatments: Para. 1]. Therefore, the in-situ carbonization is performed by laser irradiation.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Du, Ya-Wei et al: “Physical modification of polyetheretherketone for orthopedic implants”, Frontiers of Materials Science, Higher Education Press, Beijing, vol. 8, no. 4, 21 October 2014 (2014-10-21), pages 313-324, XP 035410126, ISSN: 2095-025X, DOI: 10:1007/S111706-014-0266-4 “Du”, as applied to claim 1 above and further in view of Janna et al. US 2011/0004076 A1 “Janna”.
Regarding claim 2, Du discloses all features of the claimed invention as discussed with respect to claim 1 above. However, Du does not teach “further comprising a circuit structure which is provided near the patterned carbonization layer, and the circuit structure comprises a Wheatstone bridge circuit, an ADC module, and a Bluetooth module”; and the circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module and then is transmitted out through the Bluetooth module”.
Janna is within a related field of endeavor to the claimed invention because it involves a system and method for communicating with a medical implant (see [Abstract]).
Janna teaches “further comprising a circuit structure which is provided near the patterned carbonization layer, and the circuit structure comprises a Wheatstone bridge circuit, an ADC module, and a Bluetooth module” (“FIG. 9 schematically illustrates a first embodiment of on-board implant electronics 70. In FIG. 9, some components, such as a power supply, have been removed for clarity. The on-board implant electronics 70 includes a sensor and Wheatstone bridge assembly 72, an amplifier 74, a microprocessor 76, and a transmitter 78. In the depicted embodiment, the sensor assembly 72 includes a foil gauge connected to a Wheatstone bridge. […] The sensor assembly 72 may include any number of types of sensors including, but not limited to, a foil strain gauge, a semi-conductor strain gauge, a vibrating beam sensor, a force sensor, a piezoelectric element, a fibre Bragg grating, a gyrocompass, or a giant magneto-impedance (GMI) sensor. […] The microprocessor 76 includes an analog-to-digital converter that converts the analog signal from the sensor assembly to a digital signal. When the sensor assembly 72 is powered, the sensor assembly 72 sends a signal to the amplifier 74, which amplifies the signal. The amplified signal is sent to the microprocessor 76, which converts the signal from analog to digital. The microprocessor forms a data packet from the digital signal and transmits the data packet via the transmitter 78” [0066]; “The control unit 322 may transmit information by wire or wirelessly. The control unit 322 may use available technologies, such as ZIGBEE, BLUETOOTH, Matrix technology developed by The Technology Partnership Plc. (TTP), or other Radio Frequency (RF) technology” [0078]. As shown in FIG. 9, the on-board electronics includes a Wheatstone bridge assembly 72, and ADC converter within the microprocessor 76 and a transmitter 78. In this case, the transmitter 78 transmits information wirelessly (i.e. via the antenna emerging therefrom), the wireless communication using Bluetooth for example (see [0078]); and
“the circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module and then is transmitted out through the Bluetooth module” (See [0066] and [0078] above. Therefore, the circuit structure receives a resistance signal (i.e. giant magneto-impedance, see [0066]) of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module and then is transmitted out through the Bluetooth module (see transmitter 78 and [0078]).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the CFR-PEEK orthopedic implant of Du such that it includes a circuit structure which is provided near the patterned carbonization layer, and the circuit structure comprises a Wheatstone bridge circuit, an ADC module and a Bluetooth module; and the circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module and then is transmitted out through the Bluetooth module as disclosed in Janna in order to easily facilitate transfer of information outside of a patient’s body once the CFR-PEEK orthopedic implant is introduced thereto. A circuit containing a Wheatstone bridge circuit, an ADC module and a Bluetooth module is one of a finite number of structures which can be used to facilitate the conversion of signals into a digital form such that they can then be transmitted wirelessly (i.e. via Bluetooth, for example), with a reasonable expectation of success. Thus, modifying the CFR-PEEK orthopedic implant of Du, such that is includes a circuit structure which comprises a Wheatstone bridge circuit, an ADC module and a Bluetooth module would yield the predictable result of enabling the conversion of signals into a digital form such that they can then be transmitted wirelessly outside of a patient’s body.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Du, Ya-Wei et al: “Physical modification of polyetheretherketone for orthopedic implants”, Frontiers of Materials Science, Higher Education Press, Beijing, vol. 8, no. 4, 21 October 2014 (2014-10-21), pages 313-324, XP 035410126, ISSN: 2095-025X, DOI: 10:1007/S111706-014-0266-4 “Du”, as applied to claim 6 above and further in view of Hu, Xingjian et al. “Laser Direct-Write Sensors on Carbon-Fiber-Reinforced Poly-Ether-Ether-Ketone for Smart Orthopedic Implants”, Advanced Science, vol. 9, no. 11, 10, February 2022 “Hu”.
Regarding claim 7, Du discloses all features of the claimed invention as discussed with respect to claim 1 above, and Du further teaches “wherein the laser irradiation adopts ultraviolet nanosecond laser, […]” (“Laurens et al. reported the excimer laser with UV of 193 nm wavelength increases the surface wettability significantly by formatting polar groups, such as hydroxyl, carboxyl and peroxide groups [97]. […] As a result UV (λ = 355 nm) laser radiation was the most suitable one” [Page 319, 4.3 Excimer laser irradiation, Lines 5-8, and 12-13]. Ultraviolet radiation, by definition has wavelengths between 100 and 400 nm. Therefore, since the excimer laser can a UV of 193 nm or suitably 355 nm, the laser irradiation adopts ultraviolet nanosecond laser.).
However, Du does not teach that the laser irradiation “adopts a power of 5 W-10W, a repetition frequency of 40 kHz-100 kHz, a scanning speed of 20-110 mm/s, and a defocusing amount of 2-10 mm”.
Hu is within the same field of endeavor as the claimed invention because it involves laser direct-write sensors on carbon-fiber-reinforced poly-ether-ether-ketone for smart orthopedic implants (see [Title]).
Hu discloses teaches that the laser irradiation “adopts a power of 5 W-10W, a repetition frequency of 40 kHz-100 kHz, a scanning speed of 20-110 mm/s, and a defocusing amount of 2-10 mm” (“In this work, we used a UV nanosecond laser (355 nm, output power 5.5 W at 40 kHz” [Page 2, Para. 2, Lines 1-3], and “Figure 2, Critical laser parameters. A) Optical photos of LACP and LAP lased by 5.5 W at different laser scan rates ranging from 20 to 110 mm*s-1” [Page 3: FIG. 2], “Figure 3. Electronic properties studies of laser annealed products and simulations. Sheet resistance measurements and optical photos of a, b) LACP and c, d) LAP produced at various defocusing distances and scan rates, e) Schematic of multiple lasing in one pass with a large defocusing distance” [Page 4, FIG. 3]; “The sheet resistance changes of LACP (Figure 3a,b) and LAP (Figure 3c,d) with scan rates and defocusing distances were measured to explore the optimal laser parameters and further study the formation of conductive layers. […] When defocusing distance is below 2 mm, the high ED of the small laser spot leads to overheating and evaporation of PEEK. Conversely, excessive out-of-focus value leads to low ED so that PEEK undergoes insufficient carbonization” [Page 4, Para. 1, Lines 1-4 and 7-11]. As shown in Figure 3, the defocusing plane is positioned between 1mm and 6mm from the material surface. Therefore, the laser irradiation adopts a power of 5W-10W (i.e. 5.5 W), a repetition frequency of 40 kHz-100kHz (i.e. 40 kHz), a scanning speed of 20-110 mm/s (i.e. 20 to 110 mm*s-1), and a defocusing amount of 2-10 mm (i.e. 2 mm to 6mm, for example, see FIG. 3).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the laser irradiation of the UV nanosecond laser of Du such that it adopts a power of 5W-10W (i.e. 5.5 W), a repetition frequency of 40 kHz-100kHz (i.e. 40 kHz), a scanning speed of 20-110 mm/s (i.e. 20 to 110 mm*s-1), and a defocusing amount of 2-10 mm (i.e. 2 mm to 6mm, for example, see FIG. 3) as disclosed in Hu in order to optimally explore optimal laser parameters and further study the formation of conductive layers (see Hu: [Page 4, Para. 1, Lines 1-4 and 7-10]). These UV nanosecond laser irradiation parameters are four of a finite number of parameters which can be used to irradiate a CFR-PEEK implant with a reasonable expectation of success. Thus, modifying the laser irradiation of the UV nanosecond laser of Du such that it adopts a power of 5W-10W (i.e. 5.5 W), a repetition frequency of 40 kHz-100kHz (i.e. 40 kHz), a scanning speed of 20-110 mm/s (i.e. 20 to 110 mm*s-1), and a defocusing amount of 2-10 mm (i.e. 2 mm to 6mm, for example, see FIG. 3) as disclosed in Hu in order to optimally explore optimal laser parameters and further study the formation of conductive layers (see Hu: [Page 4, Para. 1, Lines 1-4 and 7-10]).
Claim(s) 8-9, and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Du, Ya-Wei et al: “Physical modification of polyetheretherketone for orthopedic implants”, Frontiers of Materials Science, Higher Education Press, Beijing, vol. 8, no. 4, 21 October 2014 (2014-10-21), pages 313-324, XP 035410126, ISSN: 2095-025X, DOI: 10:1007/S111706-014-0266-4 “Du”, and further in view of Janna et al. US 2011/0004076 A1 “Janna”.
Regarding claim 8, Du teaches “[…] a CFR-PEEK orthopedic implant, the CFR-PEEK orthopedic implant being used to be implanted into a human body or an animal body” (“Physical modification of polyetheretherketone for orthopedic implants” [Title]; “Polyetheretherketone (PEEK) is regarded as one of the most potential candidates for replacing current implant applications” [Abstract]; “With the carbon fibers mixed, the elastic modulus and tensile strength of carbon fiber reinforced (CFR)-PEEK are much closer to cortical bone than those of pure PEEK (Table 1, [6, 8, 17, 22]). Even more remarkable is that, CFR-PEEK has a low wear rate which will result in few wear particles, and reduce the incidence of osteolysis and prosthetic aseptic loosening [23-24]. […] At the same time, this works also showed that processing methods affected bioactivities by changing the surface roughness, and the injection molded PEEK and CFR-PEEK with smooth surfaces were demonstrated to have high measured values in initial cell adhesion and proliferation tests than those machined ones” [Page 314: 2.1 Carbon fiber reinforced PEEK]. Therefore, Du discloses a CFR-PEEK orthopedic implant, comprising a CFR-PEEK matrix and a patterned carbonization layer.);
“wherein the CFR-PEEK orthopedic implant comprises a CFR-PEEK matrix and a patterned carbonization layer, and the patterned carbonization layer is formed by performing in-situ carbonization of the CFR-PEEK matrix” (See [Page 318: Irradiation treatments: Para. 1]; “This review summarizes current physical modification techniques of PEEK for orthopedic applications, which include composite strategies, surface coating methods and irradiation treatments” [Abstract]; “Excimer laser irradiation can modify the surface properties of PEEK related to the formation of polar and reactive chemical groups on the treated surfaces [97-98]” [Page 319: Excimer laser irradiation: Para. 1]. Therefore, the patterned carbonization layer is formed by performing in-situ carbonization of the CFR-PEEK matrix. Additionally, the method involves performing in-situ carbonization of a surface of the CFR-PEEK matrix, to form a patterned carbonization layer.).
However, Du does not teach “A wireless sensing device”.
Janna is within a related field of endeavor to the claimed invention because it involves a system and method for communicating with a medical implant (see [Abstract]).
Janna teaches “A wireless sensing device” (See [0066] and [0078] as discussed in claim 2 above. Therefore, the on-board implant electronics 70 shown in FIG. 9 represents a wireless sensing device.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the CFR-PEEK orthopedic implant of Du into the on-board implant electronics 70 of Janna in order to facilitate transfer of information obtained from the CFR-PEEK orthopedic implant outside of a patient’s body.
Regarding claim 9, Du in view of Janna discloses all features of the claimed invention as discussed with respect to claim 8 above, and Janna further teaches “wherein the CFR-PEEK orthopedic implant further includes a circuit structure provided near the patterned carbonization layer; wherein the circuit structure comprises a Wheatstone bridge circuit, an ADC module and a Bluetooth module; “the circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, the amplifying signal is performed with analog-to-digital conversion through the ADC module to be converted into a digital voltage signal, and the digital voltage signal is then transmitted out through the Bluetooth module” (See [0066] and [0078] as discussed in claim 2 above.); and
“the wireless sensing device further comprises a mobile terminal which is used to receive a digital voltage signal transmitted by the Bluetooth module, and convert the digital voltage signal into the resistance signal and display it” (“FIG. 1 illustrates a system 10 for communicating with an implant in a first embodiment. The system 10 includes an orthopaedic implant 12, a coil 14, a signal generator 15, an amplifier 16, a data packet 18, a processor 20, and a receiver 22. In the depicted embodiment, the orthopaedic implant is an intramedullary nail but other types of orthopaedic implants may equally be used […] In the depicted embodiment, however, the receiver 22 is electrically connected to the processor 20 but is a separate component. As examples, the receiver 22 may be an antenna with an adapter to connect to a computer port or a wireless interface controller (also known as a wireless card) for connection to the processor 20, such as through the use of a PCI bus, mini PCI, PCI Express Mini Card, USB port, or PC Card” [0056]. In this case, the on-board implant electronics 70 represent electronics included within the orthopedic implant 12. Therefore, the wireless sensing device further comprises a mobile terminal (i.e. receiver 22 in combination with processor 20) which is used to receive a digital voltage signal transmitted by the Bluetooth module (i.e. within transmitter 78, see [0066]), and convert the digital voltage signal into the resistance signal and display it.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the CFR-PEEK orthopedic implant of Du into the on-board implant electronics 70 of Janna in order to facilitate transfer of information obtained from the CFR-PEEK orthopedic implant outside of a patient’s body.
Regarding claim 11, Du in view of Janna discloses all features of the claimed invention as discussed with respect to claim 8 above, and Janna further teaches “wherein the CFR-PEEK orthopedic implant further comprises a circuit structure which is provided near the patterned carbonization layer, and the circuit structure comprises a Wheatstone bridge circuit, an ADC module, and a Bluetooth module; and the circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module and then is transmitted out through the Bluetooth module” (See [0066] and [0078] as discussed in claim 2 above. Therefore, the CFR-PEEK orthopedic implant further comprises a circuit structure which is provided near the patterned carbonization layer, and the circuit structure comprises a Wheatstone bridge circuit, an ADC module, and a Bluetooth module (see FIG. 9); and the circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module and then is transmitted out through the Bluetooth module.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the CFR-PEEK orthopedic implant of Du such that it includes a circuit structure which is provided near the patterned carbonization layer, and the circuit structure comprises a Wheatstone bridge circuit, an ADC module and a Bluetooth module; and the circuit structure receives a resistance signal of the patterned carbonization layer, the resistance signal is converted into a voltage signal through the Wheatstone bridge circuit and is amplified to become an amplifying signal, and the amplifying signal is performed with analog-to-digital conversion through the ADC module and then is transmitted out through the Bluetooth module as disclosed in Janna in order to easily facilitate transfer of information outside of a patient’s body once the CFR-PEEK orthopedic implant is introduced thereto. A circuit containing a Wheatstone bridge circuit, an ADC module and a Bluetooth module is one of a finite number of structures which can be used to facilitate the conversion of signals into a digital form such that they can then be transmitted wirelessly (i.e. via Bluetooth, for example), with a reasonable expectation of success. Thus, modifying the CFR-PEEK orthopedic implant of Du, such that is includes a circuit structure which comprises a Wheatstone bridge circuit, an ADC module and a Bluetooth module would yield the predictable result of enabling the conversion of signals into a digital form such that they can then be transmitted wirelessly outside of a patient’s body.
Regarding claim 12, Du in view of Janna discloses all features of the claimed invention as discussed with respect to claim 8 above, and Du further teaches “wherein the patterned carbonization layer satisfies at least one of the following conditions: the patterned carbonization layer has a slender strip shape and is used to feed back a mechanical signal; the patterned carbonization layer is a curved connection structure with a plurality of slender lines and is used to feed back a temperature signal; and the patterned carbonization layer is square and is used to feed back a chemical signal” (“By the reinforcing of carbon fibers in PEEK, CFR-PEEK showed excellent biotribological property, making implant a long-term use with less wear” [Page 314, 2.1 Carbon fiber reinforced PEEK, Lines 13-15]; “Reinforced fibers (e.g., glass and carbon fibers) are used to improve the mechanical properties of PEEK and bioactive particles are considered to be used to improve the bioactivity” [Page 314, 2 PEEK composites strategies, Lines 3-6]; “Due to stable chemical and physical properties, good biocompatibility and proper mechanical properties, PEEK and its composites have been increasingly applied on orthopedics. In this review, different physical modification methods have been summarized in terms of improving the bioactivity of PEEK for long-term implantation, in which both mechanical property and bone-implant interface should be considered: 1) Compared with those of metal implants, the mechanical properties of PEEK are suitable for bone replacement. To achieve the most ideal mechanical properties, CFR-PEEK was successfully developed with excellent modulus and biotribological property” [Page 320: Summary and conclusions].
In this case, the since CFR-PEEK shows excellent biotribological properties, mechanical properties and bioactivity (i.e. active, measurable and specific response), the patterned carbonization layer satisfies at least one of the following conditions: the patterned carbonization layer has a slender strip shape and is used to feed back a mechanical signal (i.e. corresponding to a bone for example); the patterned carbonization layer is a curved connection structure with a plurality of slender lines and is used to feed back a temperature signal; and the patterned carbonization layer is square and is used to feed back a chemical signal (i.e. corresponding to the bioactivity of the CFR-PEEK).).
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 10, Du in view of Janna discloses all features of the claimed invention as discussed with respect to claim 8 above. However, the combination does not teach “wherein the wireless sensing device further comprises an in-vitro probe and a network analyzer”; and “the in-vitro probe releases a first alternating electromagnetic field, after the patterned carbonization layer senses a mechanical signal, a temperature signal or a chemical signal, a resonant frequency of the patterned carbonization layer will change, and the patterned carbonization layer generates an induced current under the first alternating electromagnetic field to generate a second alternating electromagnetic field, the second alternating electromagnetic field causes the first alternating electromagnetic field to change, the in-vitro probe senses a change in the first alternating electromagnetic field and transmits it to the network analyzer, the network analyzer converts the change of the first alternating electromagnetic field into an alternating current signal and converts the alternating current signal into an offset of a peak value of the resonant frequency and displays the offset, so as to obtain change information on the mechanical signal, chemical signal or temperature signal at an orthopedic implant injury in a human or an animal by analysis”.
During the examiner’s search the following prior art reference(s) was/were found: Fuller et al. US 5,792,668 A “Fuller”.
Fuller discloses “For in-vitro measurements, a probe is inserted into the specimen and is coupled to a network analyzer, or similar electronic system. In such in-vitro measurements, the specimen may include blood or other bodily fluid, or may be a substance unrelated to bodily fluid” [Column 2, Lines 56-58].
Therefore, Fuller discloses an in-vitro probe coupled to a network analyzer. However, Fuller does not teach “the in-vitro probe releases a first alternating electromagnetic field, after the patterned carbonization layer senses a mechanical signal, a temperature signal or a chemical signal, a resonant frequency of the patterned carbonization layer will change, and the patterned carbonization layer generates an induced current under the first alternating electromagnetic field to generate a second alternating electromagnetic field, the second alternating electromagnetic field causes the first alternating electromagnetic field to change, the in-vitro probe senses a change in the first alternating electromagnetic field and transmits it to the network analyzer, the network analyzer converts the change of the first alternating electromagnetic field into an alternating current signal and converts the alternating current signal into an offset of a peak value of the resonant frequency and displays the offset, so as to obtain change information on the mechanical signal, chemical signal or temperature signal at an orthopedic implant injury in a human or an animal by analysis”.
Therefore, no prior art references were found to teach “the in-vitro probe releases a first alternating electromagnetic field, after the patterned carbonization layer senses a mechanical signal, a temperature signal or a chemical signal, a resonant frequency of the patterned carbonization layer will change, and the patterned carbonization layer generates an induced current under the first alternating electromagnetic field to generate a second alternating electromagnetic field, the second alternating electromagnetic field causes the first alternating electromagnetic field to change, the in-vitro probe senses a change in the first alternating electromagnetic field and transmits it to the network analyzer, the network analyzer converts the change of the first alternating electromagnetic field into an alternating current signal and converts the alternating current signal into an offset of a peak value of the resonant frequency and displays the offset, so as to obtain change information on the mechanical signal, chemical signal or temperature signal at an orthopedic implant injury in a human or an animal by analysis”.
Therefore, as best understood by the examiner, this claim would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fuller et al. US 5,792,668 A “Fuller” is pertinent to the applicant’s disclosure because it discloses “For in-vitro measurements, a probe is inserted into the specimen and is coupled to a network analyzer, or similar electronic system. In such in-vitro measurements, the specimen may include blood or other bodily fluid, or may be a substance unrelated to bodily fluid” [Column 2, Lines 56-58].
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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