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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered.
Rejection under 35 U.S.C. 103 as being unpatentable over Magagnoli and in view of Hunter (2025/0049391). Evidenced by Stein (2011/0319755), Hunter et al (2024/0164642).
First the examiner notes that the current claims are directed to a spacer device (claim 26) or the spacer device in combination with a group or component for receiving and processing data (claim 40). Both claims 26 and 40 are device claims and not a method of using and both are capable of fulfilling the function language, “intended to be temporarily implanted in a patient's joint area for the replacement of a joint prosthesis and for the preservation of the dimensions or spaces of the patient's joint area before the implantation of a new prosthesis”. Both the devices of Magagnoli and Hunter can be used temporarily. Magagnoli was used as the primary reference because it teaches PMMA for fulfilling claim 36. However, par. 0067 teaches pretty much teaches all other known materials in the art including plastics, metals, and alloys.
As noted in applicant’s restatement of the rejection, Magagnoli fails is unclear as to teaching at least one temperature sensor in each condylar section.
Hunter teaches a knee spacer having a femoral part with two condylar sections and a plurality of temperature sensors (detection means) to detect possible infection. Par. 0083 teaches temperature sensors may be included within one component such as the femoral part.
It would have been obvious to one having ordinary skill in the art to have used a plurality of temperature sensors at one or more specific locations within the femoral part (one component) as taught by Hunter in the recesses 104 of the femoral part of Magagnoli to include at least one first temperature sensors in the first condylar section and at least a second temperature sensor in the other condylar section to determine the presence of an infection on the totality of the femoral part and not merely focusing on a single condyle in order to allow early detection of infection. Condylar sections are separated by a distance, as shown in the figure above, and an infection can occur at one or both of the condylar sections.
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 43-44 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 43 (The unit) incorrectly depends from claim 39 (The device).
Claim 43, “said receiving and processing group” lacks antecedent basis.
Claim 44, according to claim 43, “said group for receiving and processing” is not consistent with claim 43, “said receiving and processing group”.
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.
Claims 26, 36, 38-42, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Magagnoli and in view of Hunter (2025/0049391). Claim 42 is evidenced by Hunter et al (2024/0164642).
Magagnoli teaches a knee spacer device capable of the being implanted temporarily (also, see par. 0031).
Said knee spacer comprising at least one sensor as well as electronic circuitry for obtaining data detected by said at least one senor (at least par. 0175-0180); and
wherein said at least one sensor comprising one force or load sensor (see par. 0176); and
a tibial part 1 intended to be fixed to a patient's tibia and a femoral part 100 (having two condylar sections 102, 103) intended to be fixed to a patient's femur for slidingly engaging said tibial part.
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Said knee spacer comprising a detection means which is at least one temperature sensor (bio-sensor) in the tibial part and at least one temperature sensor (bio-sensor) in the femoral part. See par. 0178. A temperature measurement is a detection means of a possible infection.
All “at least one sensor” includes electronic circuitry for obtaining the data detected by the sensor; see par. 0175-0180. Referring to par. 0175, the spacer device 1, 100, 200 can comprise at least one specific diagnostic or measuring device, not illustrated in the figures, housed inside one of the recesses 4, 4”, 104, 104’, 204, 204’. Recesses 104 are in the both recesses.
However, Magagnoli is unclear as teaching the femoral part having at least one temperature sensor in each condylar section (102, 103).
Hunter teaches a very similar knee spacer capable of being temporarily implanted having a femoral part comprising two condylar sections and a plurality of temperature sensors (detection means) to detect possible infection; see at least par. 0082-0084, 0233.
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Par. 0083 teaches sensors such as temperature sensors (detecting temperature increases), pH sensors (detecting pH decreases), and other metabolic sensors can be used to suggest the presence of infection on or around the implant. For example, temperature sensors (plural) may be included within one or more components (such as the femoral part) of a knee prosthesis, medical device or kit in order to allow early detection of infection could allow preemptive treatment with antibiotics or surgical drainage and eliminate the need to surgically remove the knee prosthesis, medical device or kit.
Par. 0098 teaches sensors including temperature sensors at a density of greater than 10 per square centimeter may be placed randomly, or at one or more specific location within the knee replacement.
It would have been obvious to one having ordinary skill in the art to have used a plurality of temperature sensors at one or more specific locations within the femoral part (one component) as taught by Hunter in the recesses 104 of the femoral part of Magagnoli to include at least one first temperature sensors in the first condylar section and at least a second temperature sensor in the other condylar section to determine the presence of an infection on the totality of the femoral part and not merely focusing on a single condyle in order to allow early detection of infection. Condylar sections are separated by a distance, as shown in the figure above, and an infection can occur at one or both of the condylar sections.
Claim 36, see par. 0067 teaching the main body can be made of PMMA. See par. 0177 teaching the chip (with sensors) is inside the spacer device.
Claim 38, the examiner takes the position that a temperature sensor can be considered a monoclonal antibodies suitable for the supersensitive identification of bacterial presence.
Claim 39, see at least par. 0176 teaching an accelerometer which is designed to measure and/or detect acceleration. Also, see at least par. 0020 of Hunter.
Claim 40, Magagnoli teaches: [0180] As an example, the bio-sensor could comprise data transmission means to allow the detection in real time of the conditions of use of the spacer device 1, 100, 200 with which it is associated, thus allowing the operation of the spacer device 1, 100, 200 to be monitored.
The monitoring device is interpreted as the unit for detecting parameters or disturbances of a patient”. It is inherent that the unit comprises a group or component for receiving and processing the sensor data. Also, see at least figures 10-11 of Hunter et al and par. 0101-0105 which would have been obvious to have used with the device of Magagnoli for communicating with the electronic circuitry/sensors of the device. Also, see at least figures 10-11 of Hunter et al and par. 0101-0105 which would have been obvious to have used with the device of Magagnoli for communicating with the electronic circuitry/sensors of the device. Also, see the include figure taken from Stein et al below.
Claim 41, the “group or component for receiving and processing” to be capable of the operate as described in par. 0180 inherently must have a power supply component. Also, see figure 10, “POWER SUPPLY” of Hunter.
Claim 42, see at least par. 0025 of Hunter teaching a watch or cellphone which are wearable and have a power supply. The examiner further provides Hunter (2024/0164642) as evidence teaching:
[0131] Because the power coil 74 is in near-field proximity to the power coil 28, the coils are magnetically (i.e., inductively) coupled such that each coil acts as a respective winding of a transformer. This coupling occurs even though the coil 28 may be implanted in a subject such that items like air, clothing, and biological materials (e.g., skin or other tissue, and blood) separate the coils 28 and 74.
It would have been obvious to one having ordinary skill in the art to have positioned the power supply in the clothing (garment) such that the device could be indefinitely powered without further surgery.
Claim 45: The control component claimed as doing the same thing as the group or component for receiving and processing. See all claims above.
Claims 43-44 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Magagnoli and in view of Hunter (2025/0049391). Evidenced by Stein (2011/0319755).
Magagnoli and in view of Hunter (2025/0049391) teach a knee spacer device as described above for claim 40 above.
Claim 43: Magagnoli teaches the knee spacer device as described above having a chip with sensors, a miniaturized circuit and a transmission means to allow operation of the knee spacer device to be monitored (par. 0176-0180). It is inherent that the receiving and processing group includes a scanner/reader for receiving and processing the sensor data. Also, see at least figures 10-11 of Hunter et al and par. 0101-0105 which would have been obvious to have used with the device of Magagnoli for communicating with the electronic circuitry/sensors of the device. Further, it is unclear if Magagnoli and/or Hunter teach a battery in the scanner or discuss the how the chip is powered.
The examiner evidences Stein et al teaching a very similar knee spacer device including a battery in the spacer; see at least par. 0118. It would have obvious to one have ordinary skill in the art to have used a battery as taught by Stein et al to power the chip in the spacer of Magagnoli et al (or in view of Hunter) for transmitting data or maintaining memory.
Claim 44: The reader receives accelerometer data and other sensor data to inherently evaluate movement of the knee spacer device reflected by the data.
Claim 46 claims the control component further comprises a computer. See par. 0176-0180 of Magagnoli teaching real time monitoring which inherently includes a computer. Further, see at least the discussion of claim 42 above teaching a watch or cellphone. Stein et al teaches using a laptop.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/ Primary Examiner, Art Unit 3774