DETAILED ACTION
Applicant' s arguments, filed 11/04/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 07/08/2022, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-7, 9-18 and 23 are hereby the present claims under consideration.
All references to Applicant’s specification are done using the paragraph numbers assigned in the US publication of the present application US 2023/0037844 A1.
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 Objections
Claim 11 is objected to because of the following informalities:
Claim 11 lines 2-3 it appears that “faces of the sensor other than the face of the sensor that is at least in part configured to be exposed of the sensor” should read “faces of the sensor other than the face of the sensor that is at least in part configured to be exposed”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-7, 9-18 and 23 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 1 lines 6-8 recite that a sensor uses its bottom face to sense a parameter, lines 8-11 then recite that “a face of the sensor” is exposed through the aperture but it is unclear if it is the bottom, sensing face that must be exposed through the aperture, or if any face may be exposed through the aperture. For the purposes of this examination, the limitation will be interpreted as the bottom face being exposed through the aperture.
Claims 2-7, 9-18 and 23 are rejected by virtue of their dependance on claim 1.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 recites “at least one surface mounted technology (SMT) component mounted on the circuit board and operatively connected to the sensor” but the specification does not appear to support the implementation of any and all possible types of SMT components. The recitations of claim 5 lines 4-5 appear to indicate that the SMT component implemented must communicate the input it receives from the sensor to an external device via a cable. This recitation appears to convey that the SMT component is converting the sensor signals generated from the chosen sensing modality, (i.e. capacitance, resistance, or other sensing modalities) into a digital signal which can be communicated to an external device through the cable. In particular, paragraphs 0048, 0061, and 0101 recite that the SMT may be a converter to convert the capacitive signals from the pressure sensor into digital signals. It would seem that the SMT is required to perform this function as the following limitation of “a cable extending from the at least one SMT component and adapted to communicate measurements from the sensor to an external device” indicates that the SMT is supplying the measurements to the cable. Thus the specification does not support the claimed scope of any SMT connected to the sensor and further connected to the cable as it would seem that not every SMT could perform the required conversion and supply the cable with sensor measurements to be communicated to an external device.
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.
Claims 1-2, 4-7, 11-14, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Harvey US Patent Application Publication Number US 2015/0351648 A1 hereinafter Harvey in view of Bodecker US Patent Application Publication Number US 2010/0174201 A1 hereinafter Bodecker and evidenced by Wood US Patent Application Publication Number US 2014/0238153 A1 hereinafter Wood and Grewe US Patent Application Publication Number US 2015/0230907 A1 hereinafter Grewe
Regarding claim 1 Harvey discloses an implantable sensor assembly (Abstract), comprising:
a circuit board (Paragraph 0089: the printed circuit board (PCB)) comprising an aperture (Paragraph 0061: the opening within the PCB which allows the inverted pressure sensor to couple to external pressure; Fig. 2B the hole in the circuit 2040 under pressure sensor 2060);
a structure disposed on a top surface of the circuit board (Paragraph 0061 and 0090: the epoxy encapsulant);
a sensor, which is adapted to measure one or more of temperature, humidity, pressure and potential hydrogen (pH), (Paragraphs 0053-0054: pressure sensors, temperature sensors, and chemical sensors may be employed ) with a bottom face supported by the structure above the top surface of the circuit board (Paragraphs 0061 and 0090: the epoxy is applied to the PCB board, the ASIC circuitry and the bonding pads of the pressure sensor to provide protection; Fig. 2A references 2080 and 2060 appear to illustrate that the epoxy used for encapsulation is also used to bond the pressure sensor to the PCB. This depiction at least suggests the presence of a layer of epoxy between the pressure sensor and the PCB); wherein at least in part a face of the sensor is configured to be exposed through the aperture of the circuit board through lips of the compliant structure that extend between a perimeter of the bottom face of the sensor and the top surface of the circuit board (Fig. 2B references 2080: the epoxy is illustrated as having “lips” between the bottom face of the sensor and top face of the PCB to support the sensor but does not cover the part of the sensor face that is exposed through the opening. This illustration at least suggests the compliant structure extends between the pressure sensor and the PCB )
Harvey fails to explicitly disclose or reasonably suggest the structure being compliant and formed of one or more materials capable of elastic deformation with a durometer level in a range of 0 to 80 on a Shore 00 Hardness Scale.
Bodecker teaches an anchored implantable pressure monitor (Abstract). Thus, Bodecker falls within the same field of endeavor as Applicant’s invention.
Bodecker teaches an implantable sensor chip connected to a substantially rigid substrate. The substrate includes an aperture to allow a sensing face of a pressure sensor to be expose to environmental pressures. The pressure sensor is supported by substrate bond pads and a filler material disposed between the pressure sensor and the substrate except for the area of the aperture. The supporting arrangement of the sensor may reduce stresses on the sensor caused by changes in temperature and the induced changes in size of the substrate. The filler material may be any flexible material, or material capable of elastic deformation, that provides support and eliminates movement and is disposed between the bottom face of the sensor and the top face of the substrate. The sensor is further encapsulated by a material which may be the same as, or different from, the filler material and serves as a biocompatible sheathing such as silicone (Paragraphs 0102-0104).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the epoxy encapsulant of Harvey to be constructed using both the flexible filler material and encapsulant as taught by Bodecker because Bodecker teaches that such flexible materials used as a filler and encapsulant serve to insulate the sensor from stresses caused by changing temperatures of the substrate and provide a biocompatible sheathing (Bodecker: Paragraphs 0102-0104), and Harvey explicitly contemplates that the epoxy encapsulant may be replaced with a different biocompatible setting encapsulant (Harvey: paragraph 0062).
Harvey in view of Bodecker fails to further disclose the sensor assembly compliant structure formed materials with a durometer level in a range of 0 to 80 on a Shore 00 Hardness Scale.
An obvious variation of Harvey in view of Bodecker would be to use materials with a durometer level in a range of 0 to 80 on a Shore 00 Hardness Scale for both the filler material and encapsulant. Such a variation would be obvious because the exact materials and their associated properties used to construct the device is a matter of routine optimization and experimentation. This assertion is supported by both Harvey and Bodecker. Harvey explicitly contemplates the use of various materials to serve as the epoxy encapsulant (Harvey: Paragraph 0062) and thus supports the assertion that the exact materials utilized, and their particular physical properties such as hardness, are a matter of routine optimization and experimentation. Bodecker also clearly indicates that a variety of materials may be acceptable in paragraph 0103 where Bodecker recites “Filler 916 may be any flexible material that can provide support to reduce or eliminate movement in the offset direction between the sensor chip 902 and the substrate 908. The filler 916 may be the same material used to surround the implanted device 900, such as a biocompatible material like silicone or other similar material”. Thus Bodecker also explicitly contemplates variations in both the filler and encapsulant materials and their associated material properties. Additionally, silicone materials as contemplated by Bodecker, are available within the claimed hardness ranges as taught by Wood (Paragraph 0069: silicone rubber that is highly stretchable and soft, shore hardness: 00-30). Grewe further teaches implantable materials within the provided hardness range (Paragraph 0024: gel materials having a Shore 00 hardness in the range of 0 to 80). The specification does not set forth a surprising technical effect achieved by using materials having the recited hardness range and thus the limitation is considered to be drawn towards a matter of routine optimization and experimentation that is obvious in light of Harvey in view of Bodecker.
All dependent claims are rejected with the understanding that claim 1 is considered obvious in light of Harvey in view of Bodecker. References Wood and Grewe merely serve as evidence of known material properties.
Regarding claim 2, Harvey in view of Bodecker teaches the sensor assembly of claim 1. Modified Harvey fails to further disclose the sensor assembly wherein the compliant structure comprises a first portion formed of a first gel compound disposed on a first top face of the sensor opposite the bottom face; and a second portion formed of a second gel compound surrounding the sensor and extending between the first gel compound and the face of the sensor that is at least in part configured to be exposed, the lips being part of the second portion.
Bodecker teaches an implantable sensor wherein the compliant structure comprises a first portion formed of a first gel compound disposed on a first top face of the sensor opposite the bottom face (Paragraph 0103 and 0109; Fig. 14 reference 1406 and Fig. 9: the encapsulant or sheathing would surround the sensor and contact the top face); and a second portion formed of a second gel compound surrounding the sensor and extending between the first gel compound and the face of the sensor that is at least in part configured to be exposed, the lips being part of the second portion (Paragraphs 0103; Fig. 9 reference 916: the filler material is between the bottom face and substrate). Bodecker further recites that the filler and sheathing are made of any flexing biocompatible material (Paragraphs 0103-0104) which is considered to render the limitation of a first and second “gel” as obvious.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the epoxy encapsulant of Harvey to be constructed using both the flexible filler material and encapsulant as taught by Bodecker because Bodecker teaches that such flexible materials used as a filler and encapsulant serve to insulate the sensor from stresses caused by changing temperatures of the substrate and provide a biocompatible sheathing (Bodecker: Paragraphs 0102-0104), and Harvey explicitly contemplates that the epoxy encapsulant may be replaced with a different biocompatible setting encapsulant (Harvey: paragraph 0062).
Regarding claim 4, Harvey in view of Bodecker teaches the sensor assembly of claim 1. Modified Harvey further discloses the sensor assembly further comprising a polymer shell applied on the top surface of the circuit board, the polymer shell enclosing the sensor and the compliant structure (Paragraphs 0061 and 0090: the flexible elastomer coating covers the ASIC circuitry, pressure sensor, encapsulant, and PCB board).
Regarding claim 5, Harvey in view of Bodecker teaches the sensor assembly of claim 1. Modified Harvey further discloses the sensor assembly further comprising: at least one surface mounted technology (SMT) component mounted on the circuit board and operatively connected to the sensor; and a cable extending from the at least one SMT component and adapted to communicate measurements from the sensor to an external device (Paragraphs 0061-0062 and 0089-0090: the instrumentation amplifier or ASIC circuitry coupled to the sensor and the wireless transmitter circuit which is not implanted and thus an “external device” as depicted in Fig. 2B references 2010 and 2023. The circuit board includes electrical traces for connecting the various components).
Regarding claim 6, Harvey in view of Bodecker teaches the sensor assembly of claim 5. Modified Harvey further discloses the sensor assembly wherein the at least one SMT component comprises a converter adapted to convert the measurements from the sensor into digital signals (Paragraphs 0061-0062 and 0089-0090: the instrumentation amplifier or ASIC circuitry which receives signals from the pressure sensor).
Regarding claim 7, Harvey in view of Bodecker teaches the sensor assembly of claim 5. Modified Harvey further discloses the sensor assembly further comprising a polymer shell applied on the top surface of the circuit board, the polymer shell enclosing the at least one SMT component, the sensor and the compliant structure (Paragraphs 0061-0062 and 0089-0090: the flexible elastomer coating such as the two-part silicone gel which completely covers the PCB, ASIC circuitry, and pressure sensor as well as the encapsulant, or compliant structure).
Regarding claim 11, Harvey in view of Bodecker teaches the sensor assembly of claim 5. Modified Harvey further discloses the sensor assembly wherein the compliant structure fully covers all faces of the sensor other than the face of the sensor that is at least in part configured to be exposed of the sensor while allowing passages of electrical connections between the sensor to the at least one SMT component (Paragraphs 0061 and 0089-0090: the epoxy encapsulant; fig. 2B reference 2080 appears to illustrate that the epoxy encapsulant completely covers the sensor except for the exposed face and still permits electrical communication through the electrical traces).
Regarding claim 12, Harvey in view of Bodecker teaches the sensor assembly of claim 5. Modified Harvey further discloses the sensor assembly wherein electrical connections between the at least one SMT component and the sensor each comprise one or more elements selected from wire bonds, solder paste traces on the circuit board, conductive ink traces on the circuit board, and a combination thereof (Paragraphs 0062 and 0089-0090: traces on the circuit board and aluminum wires allow for the connection of the ASIC circuitry and MEMS sensor).
Regarding claim 13, Harvey in view of Bodecker teaches the sensor assembly of claim 1. Modified Harvey further discloses the sensor assembly, wherein the sensor is a pressure sensor comprising a sensing membrane (Paragraphs 0065-0066: the MEMS sensor utilizes membrane displacement to detect pressure) exposed at least in part to the aperture formed in the circuit board (Paragraphs 0061-0062 and 0089-0090: the MEMS sensor is inverted on the aperture of the PCB to couple external pressure to the sensor).
Regarding claim 14, Harvey in view of Bodecker teaches the sensor assembly of claim 13. Modified Harvey further discloses the sensor assembly further comprising a layer of hydrophobic material disposed on the sensing membrane (Paragraph 0091: soft silicone covers may be employed to cover each of the MEMS pressure sensors. It is noted that silicone is a hydrophobic material).
Regarding claim 23, Harvey in view of Bodecker teaches the sensor assembly of claim 1. Modified Harvey fails to further disclose the sensor assembly, wherein: the aperture is circular
Harvey is silent on the particular shape of the opening through which the sensing membrane is exposed. Harvey further discloses that the sensing membrane itself may be circular (Paragraph 0066). An obvious variation of modified Harvey would be to configure the opening through which the membrane is exposed to be circular such that it matched the shape of the sensing membrane. Such a variation would be obvious to try because there are a finite number of readily identifiable shapes in which the aperture could be cut with a reasonable expectation of success. In particular, one or ordinary skill in the art would recognize that the aperture should be cut to expose the entire sensing surface but not cut so large as to needlessly reduce the bonding area of the sensor to the “lips” of modified Harvey. The particular shape of the aperture does not produce a surprising technical effect and one of ordinary skill in the art would have a reasonable expectation of success when using a variety of aperture shapes including circles, squares, ovals, rectangles, etc. Thus, the shape of the aperture being a circle is considered to be an obvious variation of modified Harvey
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Harvey US Patent Application Publication Number US 2015/0351648 A1 hereinafter Harvey in view of Bodecker US Patent Application Publication Number US 2010/0174201 A1 hereinafter Bodecker as applied to claim 2 above and further in view of Bortolin US Patent Application publication Number US 2017/0056674 A1 hereinafter Bortolin.
Regarding claim 3, Harvey in view of Bodecker teaches the sensor assembly of claim 2. Modified Harvey fails to further disclose the sensor assembly wherein the first gel compound has a first viscosity and the second gel compound has a second viscosity greater than the first viscosity.
Bodecker further recites that the filler and sheathing may be made of different materials (Paragraphs 0103) which appears to suggest that the materials may have different material properties such as viscosity.
Bortolin teaches implantable electronic devices such as implantable cardiac monitors (Abstract). Thus, Bortolin falls within the same field of endeavor as Applicant’s invention.
Bortolin teaches the use of a solvent based adhesive wherein raw resin such as silicone-polyurethane copolymer (SPC) is dissolved in a solvent and then applied to a desired area. The solvent evaporates and the components are attached just before complete solvent evaporation takes place. The amount of solvent utilized and the material dissolved can be adjusted to adjust the viscosity of the adhesive (Paragraph 0066). It would further seem that the material dissolved would alter the resultant material properties of the bond and cured adhesive.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize the solvent based adhesive taught by Bortolin as the filler of Harvey in view of Bodecker because the solvent based adhesive of Bortolin allows the viscosity of the solvent to be adapted to best suit the particular environment (Bortolin: paragraph 0066) and the solvent based adhesive method of Bortolin allows for a variety of material types to be selected for creating the filler allowing the particular material properties of the resultant filler material to be adjusted to best suit the intended use.
Harvey in view of Bodecker further in view of Bortolin teaches that the viscosity of the second gel compound may be adjusted which is considered sufficient to render the claimed limitation of the “the second gel compound has a second viscosity greater than the first viscosity” as obvious since the particular viscosity and relative viscosities of the gel compounds is subject to routine optimization and experimentation to adapt the compounds to be suit the intended use and environmental factors of the sensor.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Harvey US Patent Application Publication Number US 2015/0351648 A1 hereinafter Harvey in view of Bodecker US Patent Application Publication Number US 2010/0174201 A1 hereinafter Bodecker as applied to claim 7 above and further in view of Patil US Patent Application Publication Number US 2012/0071782 A1 hereinafter Patil and further in view of the teachings of Haag US patent Application Publication Number US 2013/0248345 A1 hereinafter Haag.
Regarding claims 9 and 10, Harvey in view of Bodecker teaches the sensor assembly of claim 7. Modified Harvey fails to further disclose the sensor assembly further comprising a conductive cover applied on the polymer shell, and wherein the conductive cover comprises a layer of conductive ink.
Patil teaches methods and systems, including implants, for determining information about vascular bodily lumens (Abstract). Thus, Patil falls within the same field of endeavor as Applicant’s invention.
Patil teaches a device which may include a polymer jacket. The polymer jacket may be etched with a conductive structure by using conductive ink (Paragraph 0243).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the etching of the polymer shell with conductive ink as taught by Patil into the device of Harvey such that the silicone shell of Harvey (Harvey: paragraph 0090), a type of polymer, is etched with the conductive ink because etching the polymer shell with conductive ink may provide the device with an electromagnetic shield preventing radiation from exiting the device and blocking outside radiation from entering the device at taught by Haag below.
Haag teaches a device having an in-molded resistive and/or shielding element and a method for making the device (Abstract). Thus, Haag is reasonably pertinent to the problem at hand.
Haag teaches that conductive ink may form an electromagnetic shield which may be formed using conductive ink traces disposed on the interior or exterior of polymer components. Haag further teaches that the particular pattern used to create the shield is a design choice and the thickness and pattern of the traces may selectively inhibit radiation from different electromagnetic fields or at different frequencies to create different shielding footprints (Paragraphs 0080-0085).
Thus, Haag teaches that the conductive ink etching taught by Patil may provide the device of Harvey in view of Patil with an electromagnetic shield which can be adapted to create different shielding footprints. Such a shield may improve the function of the implantable device by blocking external signals from interfering with measurements.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Harvey US Patent Application Publication Number US 2015/0351648 A1 hereinafter Harvey in view of Bodecker US Patent Application Publication Number US 2010/0174201 A1 hereinafter Bodecker as applied to claim 1 above and further in view of Rickert US Patent Application Number US 2015/0173215 A1 hereinafter Rickert
Regarding claim 15, Harvey in view of Bodecker teaches the sensor assembly of claim 1. Modified Harvey fails to further disclose the sensor assembly further comprising a stiffener mounted on a bottom surface of the circuit board.
Rickert teaches a housing for a medical implant and a method of manufacturing such a housing (Abstract). Thus, Rickert falls within the same field of endeavor as Applicant’s invention.
Rickert teaches a medical implant wherein electronic components are arranged on the top side of and attached to a base substrate. The electronic components such as the circuit board are directly attached to the substrate and additional components such as pressure sensors may be arranged on the circuit board (Paragraph 0059). Rickert further teaches that the base substrate may be metallic (Paragraph 0087).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the metallic base substrate of Rickert into the device of Modified Harvey such that the circuit board of Harvey is arranged on top of the base substrate because the addition of a base substrate may help protect the circuitry of Modified Harvey from undesired bending and may help protect the circuitry by adding an additional layer of material between the circuitry and the external environment.
Furthermore, it would be obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the base substrate of Harvey in view of Rickert such that the opening in the circuitry of Harvey to expose the pressure sensor is aligned with a hole in the base substrate of Rickert because Harvey teaches that the opening is required to couple the pressure sensor to the external pressure and such a modification would be the result of nothing more than routine optimization and experimentation of Harvey in view of Rickert.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Harvey US Patent Application Publication Number US 2015/0351648 A1 hereinafter Harvey in view of Bodecker US Patent Application Publication Number US 2010/0174201 A1 hereinafter Bodecker in view of Rickert US Patent Application Number US 2015/0173215 A1 hereinafter Rickert as applied to claim 15 above and further in view of Patil US Patent Application Publication Number US 2012/0071782 A1 hereinafter Patil and further in view of the teachings of Haag US patent Application Publication Number US 2013/0248345 A1 hereinafter Haag.
Regarding claims 16 and 17, Harvey in view of Bodecker further in view of Rickert teaches the sensor assembly of claim 15. Modified Harvey fails to further disclose the sensor assembly further comprising a conductive cover, wherein: the stiffener is made of a conductive material; and the stiffener is electrically connected to the conductive cover, and wherein the conductive cover comprises a layer of conductive ink.
Rickert teaches a medical implant wherein electronic components are arranged on the top side of and attached to a base substrate. The electronic components such as the circuit board are directly attached to the substrate and additional components such as pressure sensors may be arranged on the circuit board (Paragraph 0059). Rickert further teaches that the base substrate may be metallic (Paragraph 0087).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the metallic base substrate of Rickert into the device of modified Harvey such that the circuit board of Harvey is arranged on top of the base substrate because the addition of a base substrate may help protect the circuitry of modified Harvey from undesired bending and may help protect the circuitry by adding an additional layer of material between the circuitry and the external environment.
Furthermore, it would be obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the base substrate of Harvey in view of Bodecker further in view of Rickert such that the opening in the circuitry of Harvey to expose the pressure sensor is aligned with a hole in the base substrate of Rickert because Harvey teaches that the opening is required to couple the pressure sensor to the external pressure and such a modification would be the result of nothing more than routine optimization and experimentation of Harvey in view of Rickert.
Harvey in view of Bodecker further in view of Ricker fail to further teach the sensor assembly further comprising a conductive cover, and the stiffener is electrically connected to the conductive cover, and wherein the conductive cover comprises a layer of conductive ink.
Patil teaches a device which may include a polymer jacket and a metallic jacket. The polymer jacket may be etched with a conductive structure by using conductive ink and the conductive ink may be electrically connected to the metallic jacket (Paragraph 0243).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the etching of the polymer shell with conductive ink as taught by Patil into the device of Harvey such that the silicone shell of Harvey (Harvey: paragraph 0090), a type of polymer, is etched with the conductive ink and the conductive ink is electrically connected to the metallic base substrate of Harvey in view of Bodecker further in view of Ricker because etching the polymer shell with conductive ink may provide the device with an electromagnetic shield preventing radiation from exiting the device and blocking outside radiation from entering the device at taught by Haag below. Furthermore, connecting the conductive ink etching to the metallic base substrate may help ensure that there are no gaps in the shielding.
Haag teaches a device having an in-molded resistive and/or shielding element and a method for making the device (Abstract). Thus, Haag is reasonably pertinent to the problem at hand.
Haag teaches that conductive ink may form an electromagnetic shield which may be formed using conductive ink traces disposed on the interior or exterior of polymer components. Haag further teaches that the particular pattern used to create the shield is a design choice and the thickness and pattern of the traces may selectively inhibit radiation from different electromagnetic fields or at different frequencies to create different shielding footprints (Paragraphs 0080-0085).
Thus, Haag teaches that the conductive ink etching taught by Patil may provide the device of Harvey in view of Patil with an electromagnetic shield which can be adapted to create different shielding footprints. Such a shield may improve the function of the implantable device by blocking external signals from interfering with measurements.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Harvey US Patent Application Publication Number US 2015/0351648 A1 hereinafter Harvey in view of Bodecker US Patent Application Publication Number US 2010/0174201 A1 hereinafter Bodecker in view of Rickert US Patent Application Number US 2015/0173215 A1 hereinafter Rickert as applied to claim 15 above and further in view of Ohkoshi US Patent Application Publication Number US 2014/0187876 A1 hereinafter Ohkoshi
Regarding claim 18, Harvey in view of Bodecker further in view of Ricker teaches the sensor assembly of claim 15. Modified Harvey fails to further disclose the sensor assembly, wherein the stiffener has a hook hole adapted for mating with a hook of an insertion device.
Ohkoshi teaches a sensor inserting device for inserting a sensor into the body of a patient (Abstract). Thus, Ohkoshi falls within the same field of endeavor as Applicant’s invention.
Ohkoshi teaches a sensor assembly wherein the sensor assembly includes a sensor base including hook holes in the sensor base. The sensor base hook holes are adapted to engage with retaining protrusions to allow the insertion of a detector into the patient (Paragraphs 0071 and 0079; Fig. 5 refences 12, 14, 56, and 58). It is noted that while the entire sensor unit (50) of Ohkoshi is not inserted into the body, the hook holes in a base plate taught by Ohkoshi still facilitate the insertion of a detector into the body and are thus relevant to any instance where a sensor is being inserted into a body.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the base plate of Harvey in view of Bodecker further in view of Ricker to incorporate hook holes as taught by Ohkoshi because the hook holes may be adapted to help facilitate the insertion process of the sensor and one of ordinary skill in the art would recognize that the exact size, shape, configuration, and location of the hook holes on the base plate of Harvey in view of Bodecker further in view of Ricker further in view of Ohkoshi could be adapted based on the particular dimensions of the sensor and insertion technique being utilized.
Response to Arguments
Applicant's arguments filed 11/05/2025 have been fully considered but they are not persuasive.
Regarding the rejections previously under 35 USC 112(b):
Applicant’s amendments have overcome the previously presented rejections. New grounds of rejection have been necessitated by the amendments.
Regarding the rejections previously under 35 USC 112:
The rejections to claims 1, 4, 9, and 15-16 are withdrawn.
The rejection of claim 5 is not overcome for the since claim 5 recites “at least one surface mounted technology (SMT) component mounted on the board and operatively connected to the sensor” in lines 2-3 but the specification does not appear to support the implementation of any and all possible types of SMT components. Additionally, the recitations of claim 5 lines 4-5 appear to indicate that the SMT component implemented must communicate the input it receives from the sensor to an external device. This recitation appears to convey that the SMT component is converting the sensor signals generated from the chosen sensing modality, (i.e. capacitance, resistance, or other sensing modalities) into a digital signal which can be communicated to an external device. In particular, paragraphs 0048, 0061, and 0101 recite that the SMT may be a converter to convert the capacitive signals from the pressure sensor into digital signals. It would seem that the SMT is required to perform this function as the following limitation of “a cable extending from the at least one SMT component and adapted to communicate measurements from the sensor to an external device” indicates that the SMT is supplying the measurements to the cable. Thus the specification does not support the claimed scope of any SMT connected to the sensor and further connected to the cable as it would seem that not every SMT could supply the cable with sensor measurements.
Regarding the rejections previously under 35 USC 103:
Applicant argues that the complaint structure is not equivalent to the epoxy encapsulant of Harvey. Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In particular, Bodecker is newly applied to teach the compliant structure.
Applicant argues that the elastomer coating of Harvey is not equivalent to the claimed polyester shell. Applicant’s arguments are not found to be persuasive because claims 4 and 7 recite “a polymer shell” and does not recite specific stiffness or material requirements for the shell. Thus any polymer layer that covers the circuit board and encloses the sensor and complaint structure is considered a “shell” regardless of its composition or material properties.
Applicant argues that the limitation of “a sensor supported by the compliant structure above the top surface of the board” is not taught by Harvey because the Office Action cites a figures that suggests the teaching rather than citing explicit teachings of Harvey. This argument is not found to be persuasive because Harvey clearly illustrates the claimed structure. The figures of Harvey are considered part of the disclosure and while Harvey may not explicitly describe the presence of the epoxy between the sensor and circuit board, it is clearly illustrated in the figures which serves to at least suggest the limitation. The limitation is considered obvious over this teaching of Harvey. Additionally, newly cited Bodecker explicitly teaches this limitation.
Applicant’s arguments drawn towards the epoxy encapsulant of Harvey not being equivalent to the claimed complaint structure arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In particular, Bodecker is newly applied to teach the compliant structure.
Applicant argues that a person of ordinary skill in the art could not perceive a perimeter of a bottom face of a sensor from a cross sectional image.
This argument is not found to be persuasive because one of ordinary skill in the art would recognize that a cross sectional image is a two dimensional view of a three dimensional object and would be able to extrapolate that components illustrated in the two dimensional image have a three dimensional shape and thus a three dimensional perimeter. One of ordinary skill in the art would further recognize that a cross sectional view of an object does not particularly constrain the three dimensional shape of an object, for example a cross sectional view of a circle, square, rectangle, rhombus, or indeed many other shapes may all appear to be a square or rectangle in a cross sectional view while the three dimensional shape is not represented.
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.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791