DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on May 12, 2026 was considered by the examiner. Claims 1-20 are pending in the application.
Terminal Disclaimer
The terminal disclaimer filed on May 12, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of application number 18/561,471 has been reviewed and is accepted.
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 6, 10, and 14 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 6 recites the limitation “the face” in line 2. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a face” would overcome the present rejection. The claim is being read as such for the purposes of examination.
Claim 10 recites “each connected to an electrical terminal” in line 2; however, the relationship between this “electrical terminal” and the recitations “two electrical terminals” in claim 1, line 10, and “a respective electrical terminal” in line 12, is not clear. Amending this recitation to “each connected to a respective electrical terminal of the two electrical terminals” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 14 recites “an output parameter” in line 5, but it is not clear if this recitation is the same as, related to, or different from the recitation “an output parameter” in claim 13, line 6. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the output parameter”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being read as the same.
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 1-4, 6, 8-9, 11-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Grumm (US Patent Application Publication 2007/0205701 – cited in prior action), hereinafter Grumm, and in view of Han et al. (US Patent Application Publication 2022/0354428 – cited in prior action), hereinafter Han, and in view of Tang (US Patent Application Publication 2019/0325185 – cited in prior action), hereinafter Tang, and in view of Miyoshi et al. (US Patent 10,575,087 – cited in prior action), hereinafter Miyoshi, and in view of Sabet et al. (“Analytical and Computational Solutions to Piezoelectric Bending: A Comparative Study”, NSTI-Nanotech, Vol. 3, 2007 – cited in prior action), hereinafter Sabet, and in view of Nemoto (US Patent Application Publication 2012/0089033), hereinafter Nemoto.
Regarding Claim 1, Grumm teaches a system with a composite article for measuring a signal generated by the piezoelectric layer (see abstract and Figs. 1-4). Grumm teaches a vibration sensor for measuring at least one periodic vital signal of an individual (see abstract and ¶[0056] the system 32 may be utilized with an infant or patient, so as to monitor breathing; Fig. 13), the vibration sensor comprising:
a stack of layers extending parallel to a main plane (¶[0028] and ¶[0036] the composite article 20; Figs. 1-4) and including an active layer of piezoelectric material (¶[0028]-[0031] the piezoelectric layer 22, such as a crystalline ceramic; Figs. 1-4) and two contact electrodes arranged on at least one face of the active layer (¶[0031]-[0036] the first and second conductive layers 28/30, which are electrodes; Figs. 1-4);
wherein the vibration sensor is configured to be placed in contact with the individual (¶[0056] the system 32 may be utilized with an infant or patient, so as to monitor breathing, the composite article 20 is disposed on top of the mattress 60; Fig. 13).
Grumm teaches that wires 36/38 may connect the composite article 20 to the control device 34, the wires36/38 connected to the composite article 20 via conductive tape 40 (see ¶[0037]; Fig. 4), but does not specifically teach a flexible support layer configured to transmit a deformation to the active layer of the stack of layers at each pulse of the vital signal, the support layer extending parallel to the main plane; a printed circuit comprising two electrical terminals, an electrical connection layer, arranged between the stack of layers and the support layer, to connect each contact electrode to a respective electrical terminal of the two electrical terminals, wherein the electrical connection layer provides a direct and homogeneous contact over substantially an entire face of the stack of layers.
Han teaches a non-invasive electronic device including a sensing unit for monitoring a user’s health condition while worn on the user’s skin (see abstract and Fig. 1), in which the patch 60 (see ¶[0084], the patch 60 may have a thickness of 20 µm) (see ¶[0088]-[0090]; Figs. 1 and 3) includes a sensor module 30, including an electronic circuit unit 300, a first passivation layer 200, and/or a second passivation layer includes 400 (see ¶[0097]-[0098]; Figs. 1 and 3), in which the first/lower passivation layer 200 (see ¶[0104]-[0105], the first passivation layer 200 may have a thickness of 2 µm) acts as a protective layer between the patch 60 and the electronic circuit unit 300, the passivation layers protect the electronic circuit unit 300 from an outside environment (see ¶[0098]-[0101]; Figs. 1 and 3), in which the electronic circuit unit 300 includes an interconnect 301, positioned on the flexible patch 60 and/or the first passivation layer 200, and is configured to allow the flow of electric current outputted from the device units (for example, a sensing unit), including electrodes, transmitted to an analyzer (see ¶[0107]-[0112]; Figs. 1 and 3), in which the sensors may include a strain sensor (see ¶[0113]-[0114]), in which the interconnect 301 is formed by depositing a material on the first passivation layer 200, the deposits would be considered a printed circuit (see ¶[0316]-[0320]). Furthermore, the interconnect 301 falls within the BRI of the claim language to provide a direct and homogeneous contact over substantially an entire face of the stack of layers, as the interconnect 301 provides coverage for the entirety of the adjacent passivation layers 200/400, and is homogenous material (i.e., gold) (see ¶[0111] and Fig. 1). The sensing units may fall within the same plane as the interconnect 301, but are themselves not part of the interconnect 301 layer.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the printed circuit interconnect of Han, deposited on a first passivation layer on a patch, and second passivation layer, with the composite article of Grumm, so as to allow the flow of electric current outputted from the electrodes to the analyzer (i.e., the control device, see Grumm Fig. 4) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Grumm requires output of the signals from the composite article to the control device, and Han teaches one such modality of signal interconnect; and/or (3) the passivation layers would protect the electronics from an external environment (see Han ¶[0098]); and/or (4) the passivation layers improve mechanical robustness of the sensor module (see Han ¶[0174]). Here, each connection of the first/second electrode to the interconnect is the first/second electrical terminal. Furthermore, the patch side would be the patient contact side as taught in Han.
Han teaches that strain may be measured through the flexible patch 60 and/or the first passivation layer 200, via the strain sensor (see ¶[0113]-[0114]), which may be implemented through a piezoelectric material (see ¶[0168]-[0169]), indicating that deformation is capable of being transmitted through the flexible patch 60 and/or the first passivation layer 200.
Alternatively and/or additionally, Tang teaches a sensor device comprising a two-dimensional array of transducers (see abstract and Figs. 1A-2) including a piezoelectric layer 110 sandwiched between lower and upper electrodes 106/108 (see ¶[0042]-[0043]; Figs. 1A-2), in which an acoustic coupling layer 114 may also be included, that provides a contact surface and supports transmission of acoustic signals (i.e., vibrations) (see ¶[0044]; Figs. 1A-2), in which the acoustic coupling layer 114 may have a similar acoustic impedance to the optional platen layer 116, such as between 0.8 to 4 MRayl, or in applications of skin contact, 1.6x106 Rayl (see ¶[0050]). Here, 1 Rayl is equal to 1 Pa*s/m, such that 1 MRayl is equal to 1x106 Pa*s/m.
Accordingly, 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 patch layer of the modified Grumm as the acoustic coupling later as taught in Tang (i.e., the skin acoustic impedance for skin contact) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the acoustic coupling layer would help to support the transmission of acoustic signals (see Tang ¶[0044]).
The modified Grumm does not specifically teach that the active layer has a thickness less than or equal to 20 microns.
Miyoshi teaches a pickup sensor and a biological sensor that are small-sized and can detect micro vibrations efficiently and stably with high accuracy (see abstract and Fig. 1), comprising a piezoelectric layer 12 sandwiched with thin film electrodes 14/16 (see col. 5 ln. 32-65), in which the piezoelectric layer may have a thickness most preferably of 15 to 20 µm (see col. 17 ln. 9-25).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the thickness of the piezoelectric layer of Miyoshi as the thickness of the piezoelectric layer of the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Grumm requires a piezoelectric layer thickness, and Miyoshi teaches one such thickness; and/or (3) such a thickness would improve the followability of the piezoelectric film with respect to an applied voltage such that the sound pressure or sound quality can be improved (see Miyoshi col. 17 ln. 9-25).
The 15 to 20 µm range of the modified Grumm suggests the range of the present claim because less than or equal to 20 microns overlaps with the range of 15 to 20 µm. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Grumm teaches that the piezoelectric material may comprise ceramic crystal structures (see ¶[0030]), and Miyoshi teaches that examples of such particles include lead zirconate titanate (PZT), lead lanthanum zirconate titanate (PLZT), barium titanate (BaTiO3), zinc oxide (ZnO), a solid solution (BFBT) of barium titanate and bismuth ferrite (BiFe3), and the like (see col. 16 ln. 28-33); however, the modified Grumm does not specifically teach that the active layer has a Young's modulus greater than or equal to 60 GPa.
Sabet teaches of computational and analytical studies conducted on piezoelectric beams of various lengths and thickness (see abstract), in which barium titanate has a Young’s modulus of 67 GPa (see pg. 190, Table 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the barium titanate with Young’s modulus 67 GPa as indicated in Sabet as the piezoelectric ceramic in the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Grumm requires a piezoelectric material Young’s modulus, and Sabet teaches one such piezoelectric material Young’s modulus.
The modified Grumm does not specifically teach that the support layer has a stiffness between 1,150,000 N/m and 6,900,000 N/m.
Nemoto teaches a bioinformation detecting device 2 including a pressure sensitive plate 10, a substrate 30, and piezoelectric elements 60/80 (see abstract and ¶[0026]-[0035]; Figs. 1-2), to detect vibrations (see ¶[0007] and ¶[0027]), in which the components may be comprises of high-rigid resin and ceramics, so as to not generate delay in signal transmission (see ¶[0027]-[0029]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the high-rigid resin and ceramics of Nemoto as the support layer in the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Grumm requires a material, and Nemoto teaches one such material; and/or (3) the high-rigidity resin and ceramics would help to not generate delay in signal transmission (see Nemoto ¶[0027]-[0029]). Note, that the specification of the present application details that the support layer typically has a stiffness between 1150000 N/m and 6900000 N/m so as to “effectively transmit a deformation” (see specification ¶[0066]); and may comprise epoxy resin reinforced with glass fibers (see ¶[0065]). Therefore, as the material composition and property (i.e., to effectively transmit a deformation/not generate a delay in signal transmission), the support layer of the modified Nemoto would have the required stiffness of between 1150000 N/m and 6900000 N/m.
Regarding Claim 2, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. The modified Grumm further teaches an impedance matching layer having an acoustic impedance between 5x105 Pa*s/m and 3x106 Pa*s/m, and arranged on a face of the support layer opposite a face of the support layer in contact with the electrical connection layer (see Han ¶[0088]-[0090], the patch 60, Figs. 1 and 3; see Tang ¶[0044] and ¶[0050], the acoustic coupling layer 114, in applications of skin contact, with acoustic impedance of 1.6x106 Rayl). Note that 1.6x106 Rayl is equal to 1.6x106 Pa*s/m.
Regarding Claim 3, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. Grumm further teaches the piezoelectric material of the active layer comprises a ceramic material in monocrystalline, poly-crystalline or composite form (¶[0030] the piezoelectric material may comprise ceramic crystal structures).
Regarding Claim 4, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. The modified Grumm further teaches the support layer is self-supporting and has a thickness of less than or equal to 500 microns (see Han ¶[0104]-[0105], the first passivation layer 200 may have a thickness of 2 µm; see Nemoto ¶[0027]-[0029] the high-rigid resin and ceramics); and
the impedance matching layer has a thickness greater than or equal to 10 microns (see Han ¶[0084], the patch 60 may have a thickness of 20 µm).
The modified Grumm does not specifically teach a thickness of the first/second conductive/electrodes.
Miyoshi further teaches that the thickness of the electrodes may be 1.2 µm or less, more preferably 0.3 µm or less, and still more preferably 0.1 µm or less (see col. 19 ln. 42 – col. 20 ln. 5).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the thickness of the electrodes of Miyoshi as the thickness of the conductive/electrodes of the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Grumm requires a conductive/electrode thickness, and Miyoshi teaches one such thickness; and/or (3) such a thickness would not deteriorate the flexibility of the piezoelectric layer (see Miyoshi col. 19 ln. 47-62).
Here, the electrodes, at their thickest (i.e., 1.2 µm) would have a cumulative thickness of 2.4 µm. The modified Grumm teaches that the piezoelectric layer may have a thickness of 15 to 20 µm (see Miyoshi col. 17 ln. 9-25). As 2.4 µm is less than twice the smallest thickness of the piezoelectric layer (i.e., 15 µm x2 = 30 µm), the modified Grumm teaches the recitations as required by the present claim.
Regarding Claim 6, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. The modified Grumm further teaches the support layer includes a membrane arranged on a face of the printed circuit opposite the face of the printed circuit in contact with the electrical connection layer (see Han ¶[0103] and ¶[0316]-[0320], the passivation layer 200 may be made of polyimide, the membrane is the face of the polyimide that the electronic circuit unit 300/interconnect 301 is printed on, which is in contact of the membrane, opposite the electrode connection side).
Regarding Claim 8, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. The modified Grumm does not specifically teach that the support layer comprises a stiffening structure, fixedly connected to a peripheral zone of the support layer.
Miyoshi further teaches a case 42, formed of plastic, metal, wood, or the like, that has a box shape with an open surface surrounding and accommodating the film 10 and the viscoelastic support 46 (see col. 9 ln. 3-28; Fig. 5).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the case of Miyoshi surrounding and connected to the composite article, including the passivation layer 200 of the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the case would help to protect the periphery and backside (i.e., the non-contacting side, the passivation layer 400).
Regarding Claim 9, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. The modified Grumm further teaches wherein the printed circuit comprises a wire connection element connecting the vibration sensor to an electronic terminal (see Grumm ¶[0037], the wires 36/38 that connect the composite article 20 to the control device 34, Fig. 4; see Han ¶[0107]-[0112], the interconnect 301, positioned on the flexible patch 60 and/or the first passivation layer 200, and is configured to allow the flow of electric current outputted from the device units (for example, a sensing unit), including electrodes, transmitted to the analyzer, Figs. 1 and 3).
Regarding Claim 11, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. The modified Grumm further teaches a peripheral seal (see Han ¶[0097]-[0098], the passivation layers 200/400 prevent contact of the electronic circuit unit 300, including the interconnect 301, from an external environment, which is seal of the periphery; Figs. 1 and 3).
Regarding Claim 12, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. The modified Grumm further teaches a protective layer arranged above and at a distance from the stack of layers (see Han ¶[0101], the second passivation layer 400 disposed higher than the first passivation layer 200 and the interconnect layer 301, the second passivation layer 400 would necessarily be disposed at a distance), the protective layer being fixedly connected to the support layer (see Han ¶[0174], the upper/lower passivation layers 400/200 encapsulate the electronic circuit unit 300, including the interconnect 301, indicating that they are connected).
Regarding Claim 13, Grumm teaches a system with a composite article for measuring a signal generated by the piezoelectric layer (see abstract and Figs. 1-4). Grumm teaches
a non-intrusive device for measuring at least one periodic vital signal of an individual (see abstract and ¶[0056], the system 32; Figs. 1-4 and 13), the non-intrusive device comprising:
at least one vibration sensor for measuring a raw signal representative of the periodic vital signal (¶[0056] the piezoelectric layer 20 is sensitive enough to produce an electrical signal from infant’s or patient’s breath, this is the raw signal, it would be an analog signal), and
an electronic terminal connected to the vibration sensor (¶[0036]-[0038] the control device 34; Fig. 4) for analyzing and interpreting the raw signal, and extracting the periodic vital signal or an output parameter representative of the periodic vital signal (¶[0056] the processor 50 of the control device that monitors the infant’s or patient’s breath, the generation of the alert signal, as the signal is analyzed by a processor, the signal would necessarily be a digital signal, the digital signal representation of the breath is the periodic vital signal and/or the output parameter, the alert signal is also an output parameter),
wherein the at least one vibration sensor comprises:
a stack of layers extending parallel to a main plane (¶[0028] and ¶[0036] the composite article 20; Figs. 1-4) and including an active layer of piezoelectric material (¶[0028]-[0031] the piezoelectric layer 22, such as a crystalline ceramic; Figs. 1-4) and two contact electrodes arranged on at least one face of the active layer (¶[0031]-[0036] the first and second conductive layers 28/30, which are electrodes; Figs. 1-4);
wherein the vibration sensor is configured to be placed in contact with the individual (¶[0056] the system 32 may be utilized with an infant or patient, so as to monitor breathing, the composite article 20 is disposed on top of the mattress 60; Fig. 13).
Grumm teaches that wires 36/38 may connect the composite article 20 to the control device 34, the wires36/38 connected to the composite article 20 via conductive tape 40 (see ¶[0037]; Fig. 4), but does not specifically teach a flexible support layer configured to transmit a deformation to the active layer of the stack of layers at each pulse of the vital signal, the support layer extending parallel to the main plane; a printed circuit comprising two electrical terminals, an electrical connection layer, arranged between the stack of layers and the support layer, to connect each contact electrode to a respective electrical terminal of the two electrical terminals, wherein the electrical connection layer provides a direct and homogeneous contact over substantially an entire face of the stack of layers.
Han teaches a non-invasive electronic device including a sensing unit for monitoring a user’s health condition while worn on the user’s skin (see abstract and Fig. 1), in which the patch 60 (see ¶[0084], the patch 60 may have a thickness of 20 µm) (see ¶[0088]-[0090]; Figs. 1 and 3) includes a sensor module 30, including an electronic circuit unit 300, a first passivation layer 200, and/or a second passivation layer includes 400 (see ¶[0097]-[0098]; Figs. 1 and 3), in which the first/lower passivation layer 200 (see ¶[0104]-[0105], the first passivation layer 200 may have a thickness of 2 µm) acts as a protective layer between the patch 60 and the electronic circuit unit 300, the passivation layers protect the electronic circuit unit 300 from an outside environment (see ¶[0098]-[0101]; Figs. 1 and 3), in which the electronic circuit unit 300 includes an interconnect 301, positioned on the flexible patch 60 and/or the first passivation layer 200, and is configured to allow the flow of electric current outputted from the device units (for example, a sensing unit), including electrodes, transmitted to an analyzer (see ¶[0107]-[0112]; Figs. 1 and 3), in which the sensors may include a strain sensor (see ¶[0113]-[0114]), in which the interconnect 301 is formed by depositing a material on the first passivation layer 200, the deposits would be considered a printed circuit (see ¶[0316]-[0320]). Furthermore, the interconnect 301 falls within the BRI of the claim language to provide a direct and homogeneous contact over substantially an entire face of the stack of layers, as the interconnect 301 provides coverage for the entirety of the adjacent passivation layers 200/400, and is homogenous material (i.e., gold) (see ¶[0111] and Fig. 1). The sensing units may fall within the same plane as the interconnect 301, but are themselves not part of the interconnect 301 layer.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the printed circuit interconnect of Han, deposited on a first passivation layer on a patch, and second passivation layer, with the composite article of Grumm, so as to allow the flow of electric current outputted from the electrodes to the analyzer (i.e., the control device, see Grumm Fig. 4) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Grumm requires output of the signals from the composite article to the control device, and Han teaches one such modality of signal interconnect; and/or (3) the passivation layers would protect the electronics from an external environment (see Han ¶[0098]); and/or (4) the passivation layers improve mechanical robustness of the sensor module (see Han ¶[0174]). Here, each connection of the first/second electrode to the interconnect is the first/second electrical terminal. Furthermore, the patch side would be the patient contact side as taught in Han.
Han teaches that strain may be measured through the flexible patch 60 and/or the first passivation layer 200, via the strain sensor (see ¶[0113]-[0114]), which may be implemented through a piezoelectric material (see ¶[0168]-[0169]), indicating that deformation is capable of being transmitted through the flexible patch 60 and/or the first passivation layer 200.
Alternatively and/or additionally, Tang teaches a sensor device comprising a two-dimensional array of transducers (see abstract and Figs. 1A-2) including a piezoelectric layer 110 sandwiched between lower and upper electrodes 106/108 (see ¶[0042]-[0043]; Figs. 1A-2), in which an acoustic coupling layer 114 may also be included, that provides a contact surface and supports transmission of acoustic signals (i.e., vibrations) (see ¶[0044]; Figs. 1A-2), in which the acoustic coupling layer 114 may have a similar acoustic impedance to the optional platen layer 116, such as between 0.8 to 4 MRayl, or in applications of skin contact, 1.6x106 Rayl (see ¶[0050]). Here, 1 Rayl is equal to 1 Pa*s/m, such that 1 MRayl is equal to 1x106 Pa*s/m.
Accordingly, 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 patch layer of the modified Grumm as the acoustic coupling later as taught in Tang (i.e., the skin acoustic impedance for skin contact) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the acoustic coupling layer would help to support the transmission of acoustic signals (see Tang ¶[0044]).
The modified Grumm does not specifically teach that the active layer has a thickness less than or equal to 20 microns.
Miyoshi teaches a pickup sensor and a biological sensor that are small-sized and can detect micro vibrations efficiently and stably with high accuracy (see abstract and Fig. 1), comprising a piezoelectric layer 12 sandwiched with thin film electrodes 14/16 (see col. 5 ln. 32-65), in which the piezoelectric layer may have a thickness most preferably of 15 to 20 µm (see col. 17 ln. 9-25).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the thickness of the piezoelectric layer of Miyoshi as the thickness of the piezoelectric layer of the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Grumm requires a piezoelectric layer thickness, and Miyoshi teaches one such thickness; and/or (3) such a thickness would improve the followability of the piezoelectric film with respect to an applied voltage such that the sound pressure or sound quality can be improved (see Miyoshi col. 17 ln. 9-25).
The 15 to 20 µm range of the modified Grumm suggests the range of the present claim because less than or equal to 20 microns overlaps with the range of 15 to 20 µm. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Grumm teaches that the piezoelectric material may comprise ceramic crystal structures (see ¶[0030]), and Miyoshi teaches that examples of such particles include lead zirconate titanate (PZT), lead lanthanum zirconate titanate (PLZT), barium titanate (BaTiO3), zinc oxide (ZnO), a solid solution (BFBT) of barium titanate and bismuth ferrite (BiFe3), and the like (see col. 16 ln. 28-33); however, the modified Grumm does not specifically teach that the active layer has a Young's modulus greater than or equal to 60 GPa.
Sabet teaches of computational and analytical studies conducted on piezoelectric beams of various lengths and thickness (see abstract), in which barium titanate has a Young’s modulus of 67 GPa (see pg. 190, Table 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the barium titanate with Young’s modulus 67 GPa as indicated in Sabet as the piezoelectric ceramic in the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Grumm requires a piezoelectric material Young’s modulus, and Sabet teaches one such piezoelectric material Young’s modulus.
The modified Grumm does not specifically teach that the support layer has a stiffness between 1,150,000 N/m and 6,900,000 N/m.
Nemoto teaches a bioinformation detecting device 2 including a pressure sensitive plate 10, a substrate 30, and piezoelectric elements 60/80 (see abstract and ¶[0026]-[0035]; Figs. 1-2), to detect vibrations (see ¶[0007] and ¶[0027]), in which the components may be comprises of high-rigid resin and ceramics, so as to not generate delay in signal transmission (see ¶[0027]-[0029]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the high-rigid resin and ceramics of Nemoto as the support layer in the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Grumm requires a material, and Nemoto teaches one such material; and/or (3) the high-rigidity resin and ceramics would help to not generate delay in signal transmission (see Nemoto ¶[0027]-[0029]). Note, that the specification of the present application details that the support layer typically has a stiffness between 1150000 N/m and 6900000 N/m so as to “effectively transmit a deformation” (see specification ¶[0066]); and may comprise epoxy resin reinforced with glass fibers (see ¶[0065]). Therefore, as the material composition and property (i.e., to effectively transmit a deformation/not generate a delay in signal transmission), the support layer of the modified Nemoto would have the required stiffness of between 1150000 N/m and 6900000 N/m.
Regarding Claim 14, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 13 as stated above. Grumm further teaches wherein the electronic terminal comprises:
an analog stage for conditioning the raw signal measured by the vibration sensor (¶[0036]-[0038] and ¶[0056] the meter 42 of the control device 34 for receiving the raw/analog electrical signal for measurement, including instrumentation purposes, for infant/patient monitoring; Figs 4 and 13);
an analog to digital conversion stage of the signal coming from the conditioning stage, stage (¶[0036]-[0038] and ¶[0056] the processor 50 of the control device that monitors the infant’s or patient’s breath, the generation of the alert signal, as the signal is analyzed by a processor, the signal would necessarily be a digital signal, as there is first an analog signal and then a digital signal, it is inherent that there would be an analog to digital conversion state, as otherwise, the processor would not be capable to analyze the signal; Figs 4 and 13); and
a digital signal processing stage for shaping the digital signal and calculating an output parameter representative of the vital signal (¶[0056] the processor 50 of the control device that monitors the infant’s or patient’s breath, the generation of the alert signal, as the signal is analyzed by a processor, the signal would necessarily be a digital signal, the digital signal representation of the breath is the periodic vital signal and/or the output parameter, determined/calculated by the processor, the alert signal is also an output parameter).
Regarding Claim 15, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 13 as stated above. Grumm further teaches the electronic terminal is configured to communicate with an external system (¶[0056] the system 32 outputs an alert signal to a remote monitor to alert parents or other caregivers).
Regarding Claim 16, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 13 as stated above. The modified Grumm further teaches an impedance matching layer having an acoustic impedance between 5x105 Pa*s/m and 3x106 Pa*s/m, and arranged on a face of the support layer opposite a face of the support layer in contact with the electrical connection layer (see Han ¶[0088]-[0090], the patch 60, Figs. 1 and 3; see Tang ¶[0044] and ¶[0050], the acoustic coupling layer 114, in applications of skin contact, with acoustic impedance of 1.6x106 Rayl). Note that 1.6x106 Rayl is equal to 1.6x106 Pa*s/m.
Regarding Claim 17, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 13 as stated above. Grumm further teaches the piezoelectric material of the active layer comprises a ceramic material in monocrystalline, poly-crystalline or composite form (¶[0030] the piezoelectric material may comprise ceramic crystal structures).
Regarding Claim 18, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 13 as stated above. The modified Grumm further teaches the support layer is self-supporting and has a thickness of less than or equal to 500 microns (see Han ¶[0104]-[0105], the first passivation layer 200 may have a thickness of 2 µm); and
the impedance matching layer has a thickness greater than or equal to 10 microns (see Han ¶[0084], the patch 60 may have a thickness of 20 µm).
The modified Grumm does not specifically teach a thickness of the first/second conductive/electrodes.
Miyoshi further teaches that the thickness of the electrodes may be 1.2 µm or less, more preferably 0.3 µm or less, and still more preferably 0.1 µm or less (see col. 19 ln. 42 – col. 20 ln. 5).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the thickness of the electrodes of Miyoshi as the thickness of the conductive/electrodes of the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Grumm requires a conductive/electrode thickness, and Miyoshi teaches one such thickness; and/or (3) such a thickness would not deteriorate the flexibility of the piezoelectric layer (see Miyoshi col. 19 ln. 47-62).
Here, the electrodes, at their thickest (i.e., 1.2 µm) would have a cumulative thickness of 2.4 µm. The modified Grumm teaches that the piezoelectric layer may have a thickness of 15 to 20 µm (see Miyoshi col. 17 ln. 9-25). As 2.4 µm is less than twice the smallest thickness of the piezoelectric layer (i.e., 15 µm x2 = 30 µm), the modified Grumm teaches the recitations as required by the present claim.
Regarding Claim 20, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 13 as stated above. The modified Grumm further teaches the support layer includes a membrane arranged on a face of the printed circuit opposite a face of the printed circuit in contact with the electrical connection layer (see Han ¶[0103] and ¶[0316]-[0320], the passivation layer 200 may be made of polyimide, the membrane is the face of the polyimide that the electronic circuit unit 300/interconnect 301 is printed on, which is in contact of the membrane, opposite the electrode connection side).
Claims 5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto as applied to claims 1 and 13 above, respectively, and in view of Seomoon et al. (US Patent Application Publication 2021/0319198 – cited in prior action), hereinafter Seomoon.
Regarding Claim 5, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. The modified Grumm teaches that the interconnect may be made of a conductive material, such as Au (see Han ¶[0111]), but does not specifically teach that the electrical connection layer comprises an interposer or by an anisotropic conductive film.
Seomoon teaches a force sensor and display device with crossing electrodes (see abstract and Figs. 1-5), in which the force sensor includes a force sensitive layer 430”, such as a piezoelectric material (see ¶[0217]-[0218]; Figs. 15-16), and that electrical connections within the display, including the connecting of a circuit board 310 to the display 300 involve the usage of anisotropic conductive film (see ¶[0094]; Fig. 3).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the anisotropic conductive film of Seomoon as the conductive material for the interconnect in the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) anisotropic conductive film is a low resistance and high reliability material (see Seomoon ¶[0094]).
Regarding Claim 19, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 13 as stated above. The modified Grumm teaches that the interconnect may be made of a conductive material, such as Au (see Han ¶[0111]), but does not specifically teach that the electrical connection layer comprises an interposer or by an anisotropic conductive film.
Seomoon teaches a force sensor and display device with crossing electrodes (see abstract and Figs. 1-5), in which the force sensor includes a force sensitive layer 430”, such as a piezoelectric material (see ¶[0217]-[0218]; Figs. 15-16), and that electrical connections within the display, including the connecting of a circuit board 310 to the display 300 involve the usage of anisotropic conductive film (see ¶[0094]; Fig. 3).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the anisotropic conductive film of Seomoon as the conductive material for the interconnect in the modified Grumm because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) anisotropic conductive film is a low resistance and high reliability material (see Seomoon ¶[0094]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto as applied to claim 1 above, and in view of Shusterman (US Patent Application Publication 2018/0020931 – cited in prior action), hereinafter Shusterman.
Regarding Claim 7, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 1 as stated above. Grumm teaches that the different layers of the composite article 20 may have different shapes, sizes, and positional disposition (see ¶[0050] and Fig. 8); however, the modified Grumm does not teach any specific surface areas.
Shusterman teaches about modular, miniaturized cardiovascular sensors for measuring vibrations via accelerometers (see abstract and Fig. 1A) or piezoelectric sensors (see ¶[0013] and ¶[0088]), and may also measure repository activity (see ¶[0121]), in which the sensors 100 comprise a housing 101 with contact membrane 101M and slot 102S for fitting therewithin the electronic circuitry 102, which includes the sensors (i.e., accelerometers, piezoelectric, etc.) (see ¶[0189] and Fig. 1A), in which the dimensions of the housing 101 are 50 mm x 25 mm x 2 mm, and the size of the circuitry 102 is 20 mm x 5 mm x 2 mm (see ¶[0189]). Here, the surface area of the contact membrane 101M would correspond to the length and width (i.e., 50 mm x 25 mm), which is 1250 mm2. Furthermore, the surface area of the sensor layers would also correspond to the length and width (i.e., 20 mm x 5 mm), which is 100 mm2.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize surface areas of Shusterman as the surface areas of the modified Grumm, the sensor surface area corresponding to the sensor layers (i.e., the piezoelectric and conductive/electrode layers) surface area of the modified Grumm, and the contact area surface area to the patch and passivation layer surface area of the modified Grumm, further supported as the passivation layers encapsulate the sensors, because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Grumm requires surface area dimensions and Shusterman teaches such dimensions; and/or (3) such as size would provide a good fit for the wearable sensor about the patient’s torso area (see Shusterman ¶[0189]).
Here, the first surface area is 100 mm2 and the second surface area is 1250 mm2, so the first surface area is 8% of the second surface area; therefore, the first surface area is less than 30% of the second surface area.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto as applied to claim 8 above, and in view of Kanegae et al. (WIPO Publication WO 2019/163740 A1 – citing to translation from Clarivate Analytics, cited in prior action), hereinafter Kanegae.
Regarding Claim 10, Grumm in view of Han, Tang, Miyoshi, Sabet, and Nemoto teaches the device of claim 8 as stated above. The modified Grumm does not specifically teach that the stiffening structure supports two electrical contact outlets, each connected to an electrical terminal, to connect the vibration sensor to an electronic terminal.
Kanegae teaches a biological vibration signal detection device comprising a more reliable connection part (see abstract and Fig. 1), in which a biological vibration signal detection means 2 is connected via wiring 3 to an information processing apparatus 4 (see pg. 4 ¶2; Fig. 1), which includes exterior protective layer 22 that encloses the vibration sensor main body 10, and prevents damage from an external environment (see pg. 5 ¶3), in which extraction electrodes 16/17/18 are utilized to connect the biological vibration signal detection means 2 (i.e., via external connection to the components) to the information processing apparatus 4 via wiring 3 and plug 31 (see pg. 8 ¶4 – pg. 9 ¶2), in which the connection between the extraction electrodes 16/17/18 and the wiring 3 is covered via shielding member 19 so as to reduce noise (see pg. 9 ¶1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the extraction electrodes, wiring, and shielding of Kanegae as the connection between the composite article 20 and the control device 34 of the modified Grumm, the extraction electrodes connected to the first and second conductive/electrode layers 28/30 via the interconnect (the first/second electrical terminals), the extraction electrodes through the external protective layer (i.e., the case) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Grumm requires a connection of the composite article 20 to the control device 34 and Kanegae teaches one such connection modality; and/or (3) only one wire would be needed, as opposed to two, reducing cost and the possibility of noise; and/or (4) the shielding member would further help to reduce noise (see Kanegae pg. 9 ¶1).
Response to Arguments
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 7, filed May 12, 2026, with respect to the objections of claims 1 and 13 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 7-11, filed May 12, 2026, with respect to the rejections of claims 1-20 under 35 U.S.C. § 112(b) have been fully considered and are persuasive, except the rejection to claim 14. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Applicant’s amendment filed on May 12, 2026.
Furthermore, with regard to claim 14, Applicant’s arguments have been fully considered and are not persuasive. As the claim is not clear as to the relationship between the recitation of claim 14 to the recitation of claim 13, the metes and bounds of claim 14 are not clear. See above 35 U.S.C. § 112(b) rejection. Therefore, Applicant’s arguments are not persuasive.
Applicant’s arguments, Double Patenting
Applicant’s arguments, see pg. 11-12, filed May 12, 2026, with respect to the rejections of claims 1-20 on the ground of nonstatutory double patenting have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 12-20, filed May 12, 2026, with respect to the rejections of claims 1-20 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Nemoto (US Patent Application Publication 2012/0089033).
Applicant prevents several arguments related to the combination Grumm in view of Han. Applicant first argues that Han is not relevant to the problem which Grumm is solving. The examiner respectfully disagrees. In response to Applicant's argument that Han is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both prior art references are in the same field of endeavor, patient monitoring, including with piezoelectric materials. Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that there is no motivation to combine Grumm in view of Han. The examiner respectfully disagrees. In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as stated above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the printed circuit interconnect of Han, deposited on a first passivation layer on a patch, and second passivation layer, with the composite article of Grumm, so as to allow the flow of electric current outputted from the electrodes to the analyzer (i.e., the control device, see Grumm Fig. 4) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Grumm requires output of the signals from the composite article to the control device, and Han teaches one such modality of signal interconnect; and/or (3) the passivation layers would protect the electronics from an external environment (see Han ¶[0098]); and/or (4) the passivation layers improve mechanical robustness of the sensor module (see Han ¶[0174]). Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that the combination of Grumm in view of Han relies on impermissible hindsight reasoning. The examiner respectfully disagrees. In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER M. ROBERTSON can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights