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 .
Information Disclosure Statement
There are references listed in the specification at [0008], [0098], [0116], [0117], and [0125]. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The use of the term “FITBIT”, “APPLE WATCH” in [0091] and KATANA in [0126], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities: The term “fusion aperture 820” recited twice in the last sentence of paragraph [0072] appears to be a typographical error for the part number, intended to be “fusion aperture 802”.
Appropriate correction is required.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
the term “circuitry and operative to:” appears to have a typographical error with an extra “and”. For readability, it appears the term is intended to be “circuitry operative to”.
The term “the each cartridge including” is suggested to be “each cartridge of the at least one cartridge including” for readability. The term “each cartridge disposed” is also suggested to be “each cartridge of the at least one cartridge disposed”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 – 10, and 12 - 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 2 (line 2), Claim 3 (line 2), Claim 4 (line 1), Claim 5 (line 1), Claim 6 (line 1), Claim 7 (line 1), Claim 12 (line 2), Claim 13 (line 2), Claim 14 (line 1), Claim 15 (line 1), Claim 16 (line 1), and Claim 17 (line 1) each recite the term “the cartridge”. It is unclear if this is intended to be one of the at least one cartridge, or the each cartridge previously recited in Claims 1 and 11 from which these claims depend. For the purposes of examination, the term “the cartridge” is deemed to claim “each cartridge of the at least one cartridge”.
Claims 9 and 19 each recite the term “wherein the at least one cartridge includes a plurality of cartridges with each disposed in a respective body and that communicate with each other in a mesh network”. It is unclear if each cartridge includes a plurality of sub-cartridges, or if there are simply more than one cartridge overall. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 9 and 19 each recite the broad recitation “wherein the at least one cartridge”, and the claim also recites “includes a plurality of cartridges with each disposed in a respective body” which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of examination, the term “wherein the at least one cartridge includes a plurality of cartridges with each disposed in a respective body and that communicate with each other in a mesh network” is deemed to claim “wherein at least a first cartridge of the at least one cartridge and at least a second cartridge of the at least one cartridge are each disposed in a respective body and the at least the first cartridge and the at least the second cartridge communicate with each other in a mesh network”.
Claim 10 recites the term “each cartridge includes”. It is unclear if this is intended to encompass the previously-recited “each cartridge” or a difference cartridge. For the purposes of examination, the term “each cartridge includes” is deemed to claim, “each cartridge of the at least one cartridge.”
Claim 20 recites the term “all of the cartridges”. It is unclear if this is intended to encompass the previously-recited “at least one cartridge”, “each cartridge”, and the “hub cartridge”, or if it is for just non-hub “cartridges.” For the purposes of examination, the term “communicate with all of the cartridges to collect recorded data from the cartridges” is deemed to claim, “communicate with all of the at least one cartridges”.
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.
Claims 1, 9 - 11, and 19 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cuevas et. al., (United States Patent Application Publication US 2017/0231559 A1), hereinafter Cuevas.
Regarding Claims 1 and 11, Cuevas discloses
For Claim 11:
An inertial measure unit sensor ([0055] “sensor 20 can be…accelerometers…gyroscopic sensor…”)(Examiner notes that the accelerometer and gyroscope sensors make up an inertial measurement unit.) for measuring an orientation of the implant ([0054] “The sensor 20 can measure movement, pressure, air flow, blood flow, position, force and/or torque.”)
Record data from the sensors ([0087] “…sensor 20…strain gauge type load sensor…the resistance of the sensor 20…The antenna 30 can transmit the fusion indicia”; [0083] “…sense the fusion indicia…”; [0055]);
For both Claims 1 and Claim 11:
An intervertebral implant ([Abstract]) comprising:
a body ([0041] “implant 200”), adapted to be implanted into an intervertebral space of a patient (Figure 1; [0041] “implant 200”), the body defining a fusion aperture ([0041] “implant 200 can be configured to include one or more apertures 252…facilitate osseointegration of the implant 200 within the intervertebral space”; [0042] “…vertical openings can have a roughly rectangular shape…apertures 252”);
at least one cartridge with each cartridge disposed in the body ([Figure 4, “sensor” 20 and “antenna” 30 collectively as a “diagnostic system 100” cartridge unit; [0046] “components of the diagnostic system 100 are shown…sensor 20 and/or the antenna 30 can be integral components with the implant 200”), the each cartridge including:
an impedance sensor ([0087] “the sensor 20…can be a strain gauge type load sensor…similar to a resistor element…”) configured to measure electrical resistance ([0087] “…similar to a resistor element…the resistance varies according to the load experienced…the resistance of the sensor 20 will increase…”);
a radio frequency (RF) transmit antenna configured to transmit a RF signal ([0043] “…an antenna 30 or other device to transmit one or more fusion indicia.”; [0058] “antenna 30...capable of transmitting information…converting power into radio waves”);
circuitry ([0083] “sensor 20…antenna 30…”) operative to:
record data from the impedance sensor ([0087] “…sensor 20…strain gauge type load sensor…the resistance of the sensor 20…The antenna 30 can transmit the fusion indicia”; [0083] “…sense the fusion indicia…”);
generate the RF signal containing the recorded data ([0043] “…an antenna 30 or other device to transmit one or more fusion indicia.”; [0058] “antenna 30...capable of transmitting information…converting power into radio waves”; [0087] “…resistance of the sensor 20…antenna 30 can transmit the fusion indicia…”);
transmit the generated RF signal to an external clinician computing device ([0064] “The receiver 50 can have a processor that enables the receiver 50 to receive and process the signal from the sensor 20, the antenna 30…”, [0065] “software associated with the receiving device 50 may analyze the data and provide summary to a clinician.”) through the RF transmit antenna ([0043] “…an antenna 30 or other device to transmit one or more fusion indicia.”; [0058] “antenna 30...capable of transmitting information…converting power into radio waves”).
Cuevas does not specifically disclose and at least partially extending into the fusion aperture. However, Cuevas does broadly disclose that [0046] “sensor 20 and/or the antenna 30 can be integral components with the implant 200” and [0049] “The sensor 20 can be placed in any location suitable for sensing the fusion indicia. As represented in Figure 4, the sensor 20 and antenna 30 extend across what could be the center aperture space. Cuevas provides a motivation to combine at [0049] “The sensor 20 can be placed in any location suitable for sensing the fusion indicia,” suggesting that sensors can be aligned anywhere that would be useful for sensing fusion indicia, which would include within the aperture space. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that the “diagnostic system 100” sensors could be rearranged to obtain measurements at any section on or within the implant 200, including at least partially extending into the fusion aperture 252. It has previously been held that the mere rearrangement of parts without modifying the operation of a device is prima facie obvious. See, e.g., In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975); see also MPEP 2144.04(VI)(C).
Regarding Claims 9 and 19, Cuevas discloses as described above, The intervertebral implant of claim 1 and The intervertebral implant of claim 11. For the remainder of Claims 9 and 19, Cuevas discloses wherein the at least one cartridge includes a plurality of cartridges (See 112(b) interpretation above, such that there are more than one cartridge as opposed to a singular cartridge with sub-cartridges.)([0035]; [0046]) with each disposed in a respective body ([0035] “in FIGS. 1 and 2 only one intervertebral implant 200 is shown positioned between the vertebrae 12. However…it is anticipated that two, three or more implants 200 can be inserted into the space between the vertebrae…”; [0046] “the sensor 20 and/or the antenna 30 can be integral components with the implant 200”; [0053]) and that communicate with each other in a mesh network ([0045] “The components of the diagnostic system 100 can be connected via a network. For instance, the network can be a wireless network, a radio network, an electric network or any other network to allow power and/or signals to be transferred between components of the diagnostic system 100.; [0053]; [0046])
Regarding Claim 10, Cuevas discloses as described above, The intervertebral implant of claim 1. For the remainder of Claim 10, Cuevas discloses wherein each cartridge ([Figure 4, “sensor” 20 and “antenna” 30 collectively as a “diagnostic system 100” cartridge unit) includes an inertial measurement unit ([0055] “sensor 20 can be…accelerometers…gyroscopic sensor…”; )(Examiner notes that the accelerometer and gyroscope sensors make up an inertial measurement unit.) and a load sensor ([0055] “…sensor 20 can be a load cell…”; [0053] “sensor 20 can include one or more sensors configured to measure different characteristics”) .
Regarding Claim 20, Cuevas discloses as described above, The intervertebral implant of claim 19. For the remainder of Claim 20, Cuevas discloses further comprising a hub cartridge ([0064] “The receiver 50…”) configured to be implanted in the patient ([0064] “…receiver 50 can be located internally or externally to the patient.”) and operative to communicate with all of the cartridges to collect recorded data from the cartridges ([0064] “The receiver 50…receive and process the signal from the sensor 20, the antenna 30, the implant 200, and/or the bone graft material 300.”; [0065] “…receiver can request information from the components of the diagnostic system 100”; [0035] “..two, three or more implants 200”) for transmission to the clinician computing device ([0064] “…the receiver 50 can provide the fusion indicia to the clinician.”; [0065] “software associated with the receiving device 50 may analyze the data and provide summary to a clinician.”)
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Cuevas in view of Hunter (United States Patent Application Publication US 2017/0196508 A1), hereinafter Hunter.
Regarding Claims 2 and 12, Cuevas discloses as described above, The intervertebral implant of claim 1 and The intervertebral implant of claim 11. For the remainder of Claims 2 and 12, Cuevas discloses wherein the body includes a through hole in communication with the fusion aperture (fig 3A, round through holes “apertures 252” on the front, flatter side of “implant 200”)(Examiner notes that the round through-hole apertures 252 on the side of “implant 200” intersect with the cavity of the elongated aperture 252” on the top ridged surface of “implant 200”)
Cuevas does not specifically disclose and the cartridge is at least partially disposed in the through hole. However, Cuevas does broadly disclose that [0046] “sensor 20 and/or the antenna 30 can be integral components with the implant 200” and [0049] “The sensor 20 can be placed in any location suitable for sensing the fusion indicia. Cuevas provides a motivation to combine at [0049] “The sensor 20 can be placed in any location suitable for sensing the fusion indicia,” suggesting that sensors can be aligned anywhere that would be useful for sensing fusion indicia, which would include within the aperture through-hole space. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that the “diagnostic system 100” sensors could be rearranged to obtain measurements at any section on or within the implant 200, including at least partially disposed in the side the fusion aperture 252 through hole. It has previously been held that the mere rearrangement of parts without modifying the operation of a device is prima facie obvious. See, e.g., In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975); see also MPEP 2144.04(VI)(C).
For an additional, specific teaching, Hunter discloses sensor instrumentation placed in and around an interbody fusion cage aperture and its through holes. Specifically for Claims 2 and 12, Hunter teaches and the cartridge is at least partially disposed in the through hole (Fig. 13C and Fig 13D, Triangle “sensors” in the round through holes perpendicular to the elongated aperture hole; [0085] “a variety of accelerometers and/or strain gauges (shown as triangles) which can be placed on and/or within the bone graft material and/or on and/or within the spinal cage”; [0086] “a wide variety of sensors”)
Hunter teaches a motivation to combine at [0085] with “The sensors can be utilized to detect and record the magnitude, direction of acceleration, orientation, vibration and shock of a given strain. Hence, detection of vibration/movement may indicate loosening within the fused disc, movement between paired spinal cage components (if more than one cage is used), breakage/failure of the spinal cage, migration of the cage(s ), vertebral subluxation (spondylolisthesis), collapse of structural elements and loss of support, as well as damage to surrounding new bone.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that inserting sensors into through-hole areas of an intervertebral cage would be useful for sensing fusion characteristics, including breakage of the intervertebral cage itself.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the diagnostic system 100 sensors and antennae on the intervertebral cage implant 200 with through-holes disclosed by Cuevas with the sensors placed within the through hole of an intervertebral cage taught by Hunter, creating a single creating a single intervertebral implant to measure fusion parameters with sensors within a through-hole relative to an aperture.
Claims 3 – 5 and 13 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cuevas in view of Aryan (United States Patent Application Publication US 2017/0095343 A1), hereinafter Aryan.
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Figure A: Examiner-annotated Aryan: Figure 3 showing a central longitudinal axis
Regarding Claims 3 and 13, Cuevas discloses as described above, The intervertebral implant of claim 1 and The intervertebral implant of claim 11. For the remainder of Claims 3 and 13, Cuevas discloses wherein the fusion aperture is an elongate aperture defining a central longitudinal axis (Fig 3A and 3B, Center aperture 252 shown at the top ridged surface along length; [0042] “…vertical openings can have a roughly rectangular shape…apertures 252”)
Cuevas does not specifically disclose and the cartridge extends along the central longitudinal axis However, as described above, Cuevas does broadly disclose that ([0046] “sensor 20 and/or the antenna 30 can be integral components with the implant 200” and [0049] “The sensor 20 can be placed in any location suitable for sensing the fusion indicia. As represented in Figure 4, the sensor 20 and antenna 30 extend along the width of the intervertebral space.
For an additional teaching, Aryan teaches an instrumented interbody cage for implantation between adjacent vertebrae in a spinal column [0005], with the instrumentation placed in different orientations relative to an aperture in the center of the implant cage. Specifically for Claims 3 and 13, Aryan teaches the cartridge extends along the central longitudinal axis (Fig. 3., “web 112” structure containing “cage force sensor 122” extending into the aperture in the center.)(Examiner notes in Figure A, Examiner-annotated Aryan: Fig. 3 that the span of the “web 122” portion that is housing the “sensor 122” has a width that extends left and right in the figure along the central longitudinal axis.)
Cuevas provides a motivation to combine at [0049] “The sensor 20 can be placed in any location suitable for sensing the fusion indicia, suggesting that sensors can be aligned anywhere that would be useful for sensing fusion indicia, which would include within the aperture space. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that the “diagnostic system 100” sensors could be rearranged to obtain measurements at any section on or within the implant 200, including extending along the central longitudinal axis of the implant. It has previously been held that the mere rearrangement of parts without modifying the operation of a device is prima facie obvious. See, e.g., In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975); see also MPEP 2144.04(VI)(c). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the diagnostic system 100 sensors and antennae on the implant 200 disclosed by Cuevas with a Aryan’s specific orientation extending along a central longitudinal axis across the aperture, creating a single intervertebral implant to measure fusion parameters with a sensor structure extending along a central longitudinal axis.
Regarding Claims 4 and 14, Cuevas discloses as described above, The intervertebral implant of claim 3 and The intervertebral implant of claim 13. For the remainder of Claims 4 and 14, Cuevas does not specifically disclose wherein the cartridge extends through the fusion aperture. However, as described above, Cuevas does broadly disclose that ([0046] “sensor 20 and/or the antenna 30 can be integral components with the implant 200” and [0049] “The sensor 20 can be placed in any location suitable for sensing the fusion indicia. As represented in Figure 4, the sensor 20 and antenna 30 extend through what could be the center aperture space.
For an additional, specific teaching, Aryan teaches wherein the cartridge extends through the fusion aperture (Fig. 3., “web 112” containing “cage force sensor 122” extending in all the way across or through the extent of the fusion aperture ]0027] “…instrumented TLIF cage…one or more apertures which may be referred to as windows”)(Examiner notes that the “web 112” extends through the aperture space to bisect the aperture, resulting in the aperture with a “edge 114” and aperture with “edge 116”.)
The motivation for Claims 4 and 14 to combine Cuevas with Aryan is the same as that described in more detail in Claim 3 (and 13). In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the diagnostic system 100 sensors and antennae on the implant 200 disclosed by Cuevas with a Aryan’s specific orientation extending along a central longitudinal axis through the aperture, creating a single intervertebral implant to measure fusion parameters with sensors extending through the aperture.
Regarding Claims 5 and 15, Cuevas discloses as described above, The intervertebral implant of claim 3 and The intervertebral implant of claim 13. For the remainder of Claims 5 and 15, Cuevas does not specifically disclose wherein the cartridge extends into the fusion aperture in a direction lateral to the central longitudinal axis. However, as described above, Cuevas does broadly disclose that ([0046] “sensor 20 and/or the antenna 30 can be integral components with the implant 200” and [0049] “The sensor 20 can be placed in any location suitable for sensing the fusion indicia. As represented in Figure 4, the sensor 20 and antenna 30 extend along the width of the intervertebral space.
For an additional, specific teaching, Aryan teaches wherein the cartridge extends into the fusion aperture in a direction lateral to the central longitudinal axis (Fig. 3., “web 112” structure containing “cage force sensor 122” extending into the aperture in the center.)(Examiner notes in Figure A, Examiner-annotated Aryan: Fig. 3 that the span of the “web 122” portion that is housing the “sensor 122” has a length that extends up and down in the figure lateral the central longitudinal axis.)
The motivation for Claims 5 and 15 to combine Cuevas with Aryan is the same as that described in more detail in Claim 3 (and 13). In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the diagnostic system 100 sensors and antennae on the implant 200 disclosed by Cuevas with a Aryan’s specific orientation extending in a direction lateral to the central longitudinal axis, creating a single intervertebral implant to measure fusion parameters with a sensor structure extending in a direction lateral to the central longitudinal axis.
Claims 6 – 8 and 16 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cuevas in view of Makarovaite, et. al., “Passive UHF RFID Voice Prosthesis Mounted Sensor for Microbial Growth Detection”, hereinafter Makarovaite.
Regarding Claims 6 and 16, Cuevas discloses as described above, The intervertebral implant of claim 1 and The intervertebral implant of claim 11. For the remainder of Claims 6 and 16, Cuevas discloses a signal transmitter ([0058] “antenna 30 can be any device capable of transmitting information…Radio-frequency identification (RFID) tag…used with a RFID reader”); and signal receiver ([0058] “…RFID reader”; [0064] “receiver 50 can be located internally or externally to the patient…receive RF signals…from the corresponding antenna 30”) overlying an external surface of the cartridge ([0064] “receiver 50 can be located internally or externally to the patient”; [0049] “the sensor 20 can be placed in any location suitable for sensing the fusion indicia”).
Cuevas does not disclose wherein the cartridge includes a biofilm sensor for detecting the presence of biofilm, the biofilm sensor including a signal transmitter and signal receiver overlying an external surface of the cartridge.
Makarovaite teaches a passive UHF RFID implantable prosthesis mounted sensor for microbial growth detection. Specifically for Claims 6 and 16, Makarovaite teaches wherein the cartridge includes a biofilm sensor for detecting the presence of biofilm ([Page 384, Right Column Paragraph 1] “…microbial growth detection…Passive ultra-high frequency (UHF) radio frequency identification (RFID) technology is a possible option for this type of wireless real-time detection”, “biofilm formation…”; Fig 2, Biofilm thickness”; [Page 387, Left Column “III. Results” section, Paragraph 2] “an increase in C. albicans biofilm thickness resulted in a noticeable frequency shift.”), the biofilm sensor including a signal transmitter ([Page 386, Right Column, Bottom] “antenna sensor…”; [Page 385, Left Column, Top] “half-wave dipole sensor with a 22 mm diameter, 14 mm height and a dipole length near 50 mm (Fig. 1B).”) and signal receiver ([Page 386, Right Column, Bottom] “…was read with the TagformancePro Voyantic RFID antenna measurement system”) overlying an external surface of the cartridge ([Page 385, Left Column, “A. Experiment Design” Section, Paragraph 1] “presented sensor faces towards the midline of the simulated trachea (wind-pipe)”)(Examiner notes that the signal transmitter is inside the body on the implant, and the signal receiver appears to be outside of the antennae and the body.)
Cuevas and Makarovaite both disclose and teach implantable members including a signal transmitter and signal receiver used for measuring parameters about the success of the implantation, Cuevas with an instrumented intervertebral implant with an antenna 30 and receiver 50 for measuring fusion parameters of implant success with RF, and Makarovaite with an instrumented implant in the neck with passive RFID technology with an antenna and a reader to measuring biofilm development parameters of implant failure (or success). Makarovaite provides a motivation to combine at [Page 384, Right Column, Paragraph 1] with “…microbial growth detection…Passive ultra-high frequency (UHF) radio frequency identification (RFID) technology is a possible option for this type of wireless real-time detection…limiting the unnecessary cost linked with prosthetic device failure and removal by allowing for early failure detection due to microbial growth,” and also [Page 389, Left Column, “IV. Conclusion” Section] “…with any necessary impedance matching adjustments, this device could detect microbial growth within other implantation sites.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that a passive RFID antenna and receiver system to detect biofilms would be useful in implants in which the development of biofilm is a costly (and dangerous) concern indicating surgical revision, such as with an intervertebral implant. It would have been predictable to use the passive RFID detection system taught by Makarovaite in any similar implant system, as it would continue to function with the purpose of detecting biofilm on an implant with RFID signal between a transmitter and receiver.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the instrumented intervertebral implant with an antenna 30 and receiver 50 disclosed in Cuevas with the passive UHF RFID system for sensing biofilm development on an implant taught by Makarovaite, creating a single instrumented intervertebral implant system sensing biofilm development with RFID, increasing prompt response to biofilm formation and positive outcomes for patients.
Regarding Claims 7 and 17, Cuevas discloses as described above, The intervertebral implant of claim 6 and The intervertebral implant of claim 16. For the remainder of Claims 7 and 17, Cuevas does not specifically disclose wherein the cartridge includes circuitry for analyzing attenuation of a signal transmitted by the signal transmitter and received by the signal receiver. Cuevas does broadly disclose signal processing capabilities for the receiver at ([0064] “receiver 50 can have a processor that enables the receiver 50 to receive and process the signal from the sensor 20, the antenna 30…”).
Makarovaite teaches circuitry for analyzing attenuation of a signal transmitted by the signal transmitter and received by the signal receiver ([Page 386, Right Column “B. Sensor Measurements” Section, 2nd Paragraph] “antenna sensor was read with the TagformancePro Voyantic RFID antenna measurement system”; Fig 2, Fig 3).
The motivation for Claims 7 and 17 to combine Cuevas with Makarovaite is the same as that described in more detail in Claim 6 (and 16). In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the instrumented intervertebral implant with an antenna 30 and receiver 50 disclosed in Cuevas with the passive UHF RFID system for sensing biofilm development on an implant taught by Makarovaite, creating a single instrumented intervertebral implant system sensing biofilm development with RFID, increasing prompt response to biofilm formation and positive outcomes for patients.
Regarding Claims 8 and 18, Cuevas discloses as described above, The intervertebral implant of claim 7 and The intervertebral implant of claim 17. For the remainder of Claims 8 and 18, Cuevas does not disclose discloses wherein the circuitry is configured to generate a range of RF signals sweeping through a defined frequency range
Makarovaite teaches wherein the circuitry is configured to generate a range of RF signals sweeping through a defined frequency range or amplitude range ([Page 385, Left Column, “A. Experiment Design” Section, Paragraph 1] “tune the frequency resonance within the desired EU UHF frequency band (near 865 MHz).”), and detect the presence of biofilm based on identifying at least a threshold change in amplitude or frequency of the received signal at one or more defined marker frequencies or defined marker amplitudes (Figure 2., “biofilm growth…noticeable resonant frequency increase…reversal in resonant frequency…”).
The motivation for Claims 8 and 18 to combine Cuevas with Makarovaite is the same as that described in more detail in Claim 6 (and 16). In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the instrumented intervertebral implant with an antenna 30 and receiver 50 disclosed in Cuevas with the passive UHF RFID system for sensing biofilm development on an implant taught by Makarovaite, creating a single instrumented intervertebral implant system sensing biofilm development with RFID, increasing prompt response to biofilm formation and positive outcomes for patients.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/ Examiner, Art Unit 3791
/PATRICK FERNANDES/ Primary Examiner, Art Unit 3791