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 .
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.
Claim 1 is 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.
As to Claim 1, the instant claim recites the limitation "the bandwidth" in line 4 and “the ultrasonic unit” in line 5. There is insufficient antecedent basis for this limitation resulting in unclear scope of the claim. It is unclear as to what “the ultrasonic unit” is referring to. Does it refer to the “transducer unit” (line 2), or the “ultrasonic transducer” (line 2). It is further unclear as to what the “bandwidth” is referring to.
Due to claim dependency, all dependent claims (i.e., claims 2 – 20) are also rejected.
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) 1 – 7, 10, 12 - 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2023/0360735 A1 to Cretu et al. (hereinafter “Cretu”) in view of U.S. Patent Application Publication No. 2019/0044459 A1 to Degertekin et al. (hereinafter “Degertekin”).
Regarding Claim 1, as best understood, Cretu teaches an implantable wireless sensor apparatus (see paragraphs [0031] and [0127] describing a wireless capacitive micromachined ultrasonic transducer (CMUT) sensor implanted inside a body of a person, see also claim 20) comprising:
a transducer unit having at least one ultrasonic transducer (see paragraphs [0078] – [0079] describing capacitive micromachined ultrasonic transducer (CMUT) and Polymer-based CMUT (polyCMUT) which comprise ultrasonic transducers, see paragraphs [0100] – [0101] describing wireless polyCMUT system 4 and paragraph [0103] describing the CMUT transducer cell structure illustrated at Figs. 3A – 3C); and
at least one body sensor (see arrangement at Figs. 3A – 3C, 4 and paragraphs [0125] and [0127] describing the wireless polyCMUT sensor being mounted/implanted inside the body of a person for a constant real-time monitoring of for example bladder, heart or other organs, thus comprising a body sensor as claimed) coupled to the transducer unit (see paragraphs [0125] and [0127], see Figs. 1 – 6).
Even though Cretu teaches the electrical resonant frequency of the second inductor and the CMUT (i.e., of the claimed apparatus) being approximately equal to a mechanical resonant frequency of the CMUT as described at paragraphs [0019], [0037], [0041], Cretu is silent regarding that electrical resonance frequency of the apparatus is within the bandwidth of mechanical resonance frequency of the ultrasonic unit.
Degertekin, in the field of parametric resonators and electrical transducers used in implantable devices as described for example at paragraphs [0016], [0018], teaches that it is known to use a device with electrical resonance frequency of the apparatus is within the bandwidth of mechanical resonance frequency of the ultrasonic unit (see paragraphs [0018], [0022], [0029] describing capacitor having a “mechanical resonance frequency equal to about twice an electrical resonance frequency of the electronic device”, thus reading on the invention as claimed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the arrangement of Degertekin into Cretu, in order to improve efficiency of the CPUT by allowing efficient energy conversion.
Regarding Claim 2, Cretu in view of Degertekin as modified above teaches wherein the at least one ultrasonic transducer is a diaphragm type ultrasonic transducer (see flexible thin membrane 23 of the CMUT unit as described at paragraph [0103] and illustrated at Figs. 3A – 3C of Cretu).
Regarding Claim 3, Cretu in view of Degertekin as modified above teaches wherein the diaphragm type ultrasonic transducer is a piezoelectric micro-machined ultrasonic transducer (PMUT) (see paragraph [0003] of Cretu and/or see paragraphs [0014], [0070], [0071], [0075], [0079] of Degertekin describing the use of piezoelectric transducers).
Regarding Claim 4, Cretu in view of Degertekin as modified above teaches wherein diaphragm surface area and/or diaphragm thickness of the ultrasonic transducers and/or nominal capacitance of the sensors are arranged such that electrical resonance frequency of the apparatus is in the bandwidth of mechanical resonance frequency of the ultrasonic unit (see modification of claim 1 above, see paragraphs [0018], [0022], [0029] describing capacitor having a “mechanical resonance frequency equal to about twice an electrical resonance frequency of the electronic device”, of Degertekin hence reading on the invention as claimed).
Regarding Claim 5, Cretu in view of Degertekin as modified above teaches wherein the at least one ultrasonic transducer is a piezoelectric ceramic ultrasonic transducer (see paragraphs [0003] of Cretu describing piezoelectric as well as ceramic based substrates at paragraph [0080] of Cretu and/or see paragraphs [0014], [0070], [0071], [0075], [0079] of Degertekin describing the use of piezoelectric transducers). Even though Cretu in view of Degertekin may be construed as not explicitly stating piezoelectric ceramic ultrasonic transducer, it would have been obvious to one having ordinary skill in the art to use a piezoelectric ceramic ultrasonic transducer, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). The modification allows for a compact size, high reliability and precise and rapid response times.
Regarding Claim 6, Cretu in view of Degertekin as modified above teaches wherein number of ceramics, ceramic surface area and/or ceramic thickness of the ultrasonic transducers and/or nominal capacitance of the sensors are arranged such that electrical resonance frequency of the apparatus is in the bandwidth of mechanical resonance frequency of the ultrasonic unit (see modification of claim 1 above, see paragraphs [0018], [0022], [0029] describing capacitor having a “mechanical resonance frequency equal to about twice an electrical resonance frequency of the electronic device”, of Degertekin hence reading on the invention as claimed).
Regarding Claims 7, 14, 15, 16, 17 and 18, Cretu in view of Degertekin as modified above teaches wherein the at least one body sensor is a capacitive, inductive or resistive sensor (see arrangement at Figs. 3A – 3C, 4 and paragraphs [0125] and [0127] of Cretu describing the wireless polyCMUT sensor being mounted/implanted inside the body of a person for a constant real-time monitoring of for example bladder, heart or other organs, thus comprising a body sensor which can be capacitive as claimed).
Regarding Claim 10, Cretu in view of Degertekin as modified above teaches wherein ultrasonic transducers are in the form of an ultrasonic transducer array (see CMUT arrays described in abstract of Cretu, see also paragraphs [0053], [0054], [0081] of Cretu and/or paragraphs [0068] – [0069] of Degertekin)
Regarding Claim 12, Cretu in view of Degertekin as modified above teaches an ultrasonic actuator (see for instance paragraphs [0101], [0126] of Cretu describing a wireless antenna 14 used to send and receive signals to and from a controller, thus the signals being sent to the ultrasound transducers would need to be ultrasonic source hence reading on the invention as claimed) used for sending ultrasonic waves to and receiving ultrasonic waves from the implantable wireless sensor apparatus according to claim 1 (see rejection of claim 1).
Regarding Claim 13, Cretu in view of Degertekin as modified above teaches wherein diaphragm surface area and/or diaphragm thickness of the ultrasonic transducers and/or nominal capacitance of the sensors are arranged such that electrical resonance frequency of the apparatus is in the bandwidth of mechanical resonance frequency of the ultrasonic unit (see modification of claim 1 above, see paragraphs [0018], [0022], [0029] describing capacitor having a “mechanical resonance frequency equal to about twice an electrical resonance frequency of the electronic device”, of Degertekin hence reading on the invention as claimed)
Claim(s) 8, 9, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cretu in view of Degertekin and further in view of U.S. Patent No. 11,980,498 B2 to Reiche et al. (hereinafter “Reiche”).
Regarding Claims 8, 19 and 20, Cretu in view of Degertekin as modified above teaches wherein the transducer unit and/or the at least one body sensor are made of biodegradable materials (see for instance paragraph [0031] of Cretu describing polymer based capacitive micromachined ultrasonic transducer implanted inside a patient).
Even though Cretu teaches a polymer based capacitive ultrasonic device as described above, Cretu in view of Degertekin is silent regarding the transducer unit and/or the at least one body sensor being made of biodegradable materials. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use biodegradable materials, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). The modification eliminates the need for secondary removal surgeries, reducing infection rates and preventing long-term foreign body reactions.
In addition, Reiche, in the field of implantable and biodegradable smart resonators with ultrasound readout, teaches that it is known to use a device with the transducer unit and/or the body sensor made of biodegradable materials (see Col. 15, line 27 – Col. 16, line 29 describing the biodegradable smart hydrogel sensor device used in the system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use biodegradable materials of Reiche into Cretu in view of Degertekin, in order to eliminate the need for a subsequent surgery/removal of the sensor structure.
Regarding Claim 9, Cretu in view of Degertekin in view of Reiche as modified above further comprising a triggered biodegradation layer which is coated on the biodegradable materials in order to initiate biodegrading of the materials by a controlled effect (see Col. 15, line 27 – Col. 16, line 29 of Reiche describing use of hydrogels for the biodegradable and implantable sensor structures, hence reading on the invention as claimed).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Cretu in view of Degertekin and further in view of U.S. Patent Application Publication No. 2021/0346726 A1 to Kiani (hereinafter “Kiani”).
Regarding Claim 11, Cretu in view of Degertekin as modified above teaches the claimed invention except for further comprising at least two implantable wireless sensor apparatus wherein each transducer unit has a different mechanical resonance frequency bandwidth (BW) in order to provide a different transmitting channel to each body sensors coupled to the corresponding transducer unit.
Kiani, in the field of implantable dual mode ultrasonic devices, teaches that it is known to use at least two implantable wireless sensor apparatus wherein each transducer unit has a different mechanical resonance frequency bandwidth (BW) in order to provide a different transmitting channel to each body sensors coupled to the corresponding transducer unit (see paragraph [0061] describing “The proposed implantable technology, which can be realized in two ways as shown in FIGS. 4A and 4B, may utilize one or an array of ultrasonic transducers in one or multiple implants distributed over the brain/nerve surface or implanted into the brain/nerve tissue for neuromodulation, imaging, or both simultaneously” and further states “These ultrasonic transducers in FIGS. 4A and 4B can be driven with a continuous or pulsed waveform or a sinusoidal carrier at high frequency (several MHz) either amplitude-modulated with a lower frequency of hundreds of kHz, or reconstructed with a train of sharp pulses with varying amplitudes. In pulse-based sonication, the number of cycles, pulse repetition frequency, and duration may be variable”, hence reading on the invention as claimed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use multiple implantable sensors of Kiani into Cretu in view of Degertekin, in order to effectively and accurately operate multiple implants within a body as per user’s need.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form accompanying this office action which includes the following relevant prior art:
Maharbiz et al. (U.S. 10,300,309 B2) teaches implants using ultrasonic backscatter for sensing physiological conditions. The systems including one or more implantable devices and an interrogator comprising one or more ultrasonic transducers configured to transmit ultrasonic waves to the one or more implantable devices or receive ultrasonic backscatter from the one or more implantable devices. Also described are methods of detecting an amount of an analyte, a pH, a temperature, a strain, or a pressure.
Degertekin et al. (U.S. 2023/0275557 A1) teaches resonator based comb generation system configured for stable frequency comb generation. The device further teaches controlling the resonance frequency of the electrical oscillator by adjusting the value of inductance.
Cosman (U.S. 4,378,809) teaches audio-telemetric pressure sensing systems and methods. The device further includes a differential pressure sensing device is fully implanted beneath the skin in the living body such that its pressure responsive means, such as a diaphragm means, senses the difference in pressure between an internal bodily pressure and the pressure on the skin which is just above the sensor.
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/MARRIT EYASSU/Primary Examiner, Art Unit 2855