DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/29/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered are seen as moot due to the change in scope of the claims. New art and combination of art is applied below. However, it is worth mentioning that the “heat bonding” of TPU and LCP is not seen as critical because on paragraph [0053] of the specification which states that bonding may include applying heat and pressure (heat bonding). The “may include” language takes the bonding practice out of criticality unless applicant can show that this is critical or that this takes the bonding out of the realm of product by process. It is suggested to file an affidavit if this is critical and if the process can be shown to materially change the product. It is worth mentioning, however, that the process of making the surface and layers of the device do appear to be unique for implantable brain stimulus devices as the soaking process which appears to be mentioned in papers after applicant’s filing dates. Furthermore, the claim terminology of “enable the device…” to fit in the subgaleal space is seen as the result of the sizing of the device, meaning that if a device is shaped/sized the same it would also be able to fit in the subgaleal space. It is suggested if the placement of the device is critical it should be actively claimed.
Claim Rejections - 35 USC § 112
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.
Claims 9-13 are 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. The claims state particularly in claim 9 encapsulating a particular portion of the surface based on surface treatment and that this does not include the substate covered by components and that a first portion of the substrate includes the components. However, this does not appear what is described in the specification in paragraph [0043]. Rather it states that a surface not covered by transducers and detectors can be covered by surface treatment. However, the following sentence states the transducers and detectors may be encapsulated in the substrate. This does not state that the surface treatment is encapsulation. Further the last sentence in [0051] appears to state that the flexible substrate with the transducers and detectors can be encapsulated with parylene layers. Therefore, claim 9 and its dependents are seen as having new matter.
It does appear that this is simply because of combining different method steps as described in the specification into a singular step in the claims. The examiner does think this is easily overcome by expanding on steps in the method of fabrication of the substrate and device to be more concrete and specific.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5, 8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier et al, US 11738214, herein referred to as “Carpentier” in view of Peters, WO 2023/239700, herein referred to as “Peters” and Bakker et al., US12343536, herein referred to as “Bakker”.
Regarding claim 1, Carpentier discloses: An apparatus (Fig. 1 and Fig. 5 specifically) comprising: a substrate (Fig. 5; substrate is seen as 22a and b the holder is seen as a substrate as it is a thin sheet with the ability to have the transducers disposed on it; column 14, lines 43-67) and a device disposed on the substrate, the device and substrate configured to be disposed between skin and a skull (Fig. 2 which shows the entire device implanted under the skin by the skull and columns 11-12, lines 64-67, 1-8; specifically that the device is implanted in the skull and below the skin 8 as seen in the fig and Fig. 5; where the transducers are on the substrate), the device comprising one or more transducers (Fig. 1 and 5; specifically transducer elements 20(a-c) where the transducers are in the substrate 22) and configured to provide a pressure wave, the pressure wave being configured to propagate a body part under the skin (Fig 2; specifically the pressure waves (ultrasound waves) going into the subject under skin 8), the pressure wave comprising a fundamental frequency in a range approximately from 20kHz to 10GHz (Column 28, lines 28-35; specifically that the frequencies of operation for the ultrasound transducers are in a range of 1 kHz – 100 MHz which lie within the range as claimed and there for discloses the limitation of the claim).
Carpentier does not explicitly disclose what materials the substrate is made of nor the specific location of implantation of the device.
Peters discloses that a substrate can comprise liquid crystal polymer (LCP) heat bonded to thermoplastic polyurethan (TPU) which is used for medical devices that are implantable with use with electrodes as well as ultrasound ([074]; specifically using materials with LCP and TPU or any combination as such). Furthermore, the heat bonding is not seen as critical as the specification states that these materials may be bonded in such a manner and therefore “heat bonding” is seen as product by process and if these two material are used together, they are seen as bonded together. The recitation of “LCP heat bonded to TPU” is regarded as a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the implantable device of Carpentier with the substrate materials of Peters. The motivation being substituting one known material silicone in a substrate for another (LCP/TPU or combination of both) for the predictable resulted of having a flexible substrate that is compatible with implantation.
Bakker discloses: the device and substrate configured to be disposed within a subgaleal space between skin and a skull (Fig. 3 and Column 1, lines14-15; specifically the implant system being a subgaleal implant meaning it is between skin and a skull).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the implantable device of Carpentier with the implantation location of Bakker. The motivation being to enable monitoring and stimulation for neurologic diseases and disorders, Bakker (Summary).
Regarding claim 2, Carpentier discloses: wherein a thickness of the apparatus ranges from 40 µm to 6 mm (Column 14, lines 35-40; specifically the holder (with transducers encases as seen in Fig. 1 and 3-6) 1-4 mm which is seen as laying within the range as claimed and therefore teaching the claim).
Regarding claim 3, Carpentier discloses: further comprising tapering on edges of the device, the tapering configured to reduce the visibility of the device contour from outside the skin (Fig. 16, Fig 5 for example all show tapered edges which are seen as configured to reduce visibility as the taper in of itself would allow for less of the device to be visible).
Regarding claim 4, Carpentier does disclose that the different sheets and substrate/holder can be made of silicone like materials and other materials that are biocompatible as seen in column 14. Carpentier does not explicitly disclose that said materials are at least one of TPU, parylene C, silicon carbide or ALD of alumina, epoxy, or other organic or inorganic coatings to prevent moisture ingress, or any combination thereof.
However, Peters discloses: further comprising a surface on the substrate, wherein the surface includes at least one of TPU, parylene C, silicon carbide or ALD of alumina, epoxy, or other organic or inorganic coatings to prevent moisture ingress, or any combination thereof ([074]; specifically using materials with LCP and TPU or any combination as such where if a substrate includes said material it would be also on its surface).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the implantable device of Carpentier with the substrate materials of Peters. The motivation being substituting one known material silicone in a substrate for another (LCP/TPU or combination of both) for the predictable resulted of having a flexible substrate that is compatible with implantation.
Regarding claim 5, Carpentier discloses: wherein the one or more transducers are between five nanometers (5 nm) and fifty microns (50 µm) thick (Column 27, lines 34-37; specifically size ranging from 10-50 µm which falls within the claimed range).
Regarding claim 8, Carpentier does disclose that the transducer elements are seen as sandwiched between two sheets of the substrate (See Figs. 3-6). Wherein the one or more transducers include piezoelectric micromachined ultrasonic transducers (PMUTs) (column 27, lines 33-40; specifically the piezoelectric components of CMUTs which is seen as a PMUTs).
Regarding claim 20, Carpentier discloses: wherein one or more transducers are between five nanometers and fifty microns thick (Column 27, lines 34-37; specifically size ranging from 10-50 µm which falls within the claimed range).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier, Peters and Bakker further in view of Pak et al., “Thin Film Encapsulation for LCP-Based Flexible Bioelectronic Implants; Comparison of Different Coating Material Using Test Methodologies for Life-Time Estimation”, Micromachines, 2022, Vol. 13, NO. 544, pg 1-14, herein referred to as “Pak” (provided by applicate in prior art/IDS).
Regarding claim 6, Carpentier, Peters and Bakker do disclose that there are a plurality of sheets for the substrate (Carpentier; Figs 3-6 and column 12; specifically the two sheets). And that the substrate is made up of LCP (Peters; [074]; specifically using materials with LCP and TPU or any combination as such) Carpentier, Peters and Bakker do not explicitly disclose that the substrate comprises a plurality of LCP sheets.
Pak discloses: However, that LCP can be used as a substrate material (abstract, page 2; specifically the flexible substrate can be made of LCP for fully implantable bioelectronic devices) and wherein the LCP of the substrate comprises a plurality of LCP sheets (Introduction: In this paper, to the best of our knowledge, we investigate for the first time the feasibility of using TFE materials with a silicone elastomer finish as a packaging solution for LCP-based implantable bioelectronics. Toward this goal, and as a first step, pre-screening tests were carried out to evaluate the interface adhesion of the TFE materials to LCP sheets – where sheets is seen as a plurality of sheets as sheets is plural of sheet and plurality means more than one and the use of the terminlology sheets is seen as having more than one LCP sheet).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the silicone sheets as taught by Carpentier to include the LCP as taught by Pak. The motivation being to replace one known biocompatible material (Silicone) with another (LCP) with the predictable result of using a material for a substrate that is able to house transducers and still reside in the brain.
Regarding claim 7, Carpentier does disclose that the sheet or sheets of the substrate can be 1-4 mm in thickness that each sheet can be in the thickness range of 5 µm to 3 mm (Column 14, lines 35-40; specifically the holder (with transducers encases as seen in Fig. 1 and 3-6) 1-4 mm which is seen as laying within the range as claimed and therefore teaching the claim). Carpentier does not explicitly disclose that the sheets are made up of LC.
However, Pak discloses: that the substrate can be out of LCP material in sheets (abstract, page 2; specifically the flexible substrate can be made of LCP for fu
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the silicone sheets as taught by Carpentier to include the LCP as taught by Pak. The motivation being to replace one known biocompatible material (Silicone) with another (LCP) with the predictable result of using a material for a substrate that is able to house transducers and still reside in the brain.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier in view of Peters.
Regarding claim 14, Carpentier discloses: A system (Fig. 13) comprising: circuitry that includes a processor configured to provide signals for brain stimulation (column 10; lines 1-67; specifically the generator with circuitry connecting the transducer to the generator which has a controller to send signals to transducers where the controller is seen as a processor); and a subcutaneous device configured to be disposed under skin (Fig. 2; specifically the device below skin (8)), the subcutaneous device including: a substrate including one or more transducers disposed on first portions of a face of the substrate, the one or more transducer configured (Fig. 1; specifically transducer elements 20(a-c) where the transducers are in the substrate 22 where the substrate is a sheet with the transducers in it see Fig. 3-6 and where the transducers 20 only cover parts of 22a/b) to provide one or more ultrasound signals as a pressure wave responsive to the signals for brain stimulation from the circuitry (Column 28; lines 1-35; specifically that ultrasound signals are sent toward the brain utilizing the generator also seen in Column 10) a surface disposed on second portions of the face of the substrate not covered by the components (Fig. 5; specifically the portions of 22b that do not have 20 aligned with the surface), wherein a thickness of the subcutaneous device including the substate, the components, and the surface is between forty microns and six millimeters to enable the subcutaneous device to fit in a subgaleal space between a skull and skin (Column 14, lines 35-40; specifically the holder (with transducers encases as seen in Fig. 1 and 3-6) 1-4 mm which is seen as laying within the range as claimed and therefore teaching the claim furthermore the size falling within the size of the range in the claim would allow it to be sized to fit in a subgaleal space between a skull and skin).
Carpentier does not explicitly disclose what materials the substrate is made of.
Peters discloses that a substrate can comprise liquid crystal polymer (LCP) heat bonded to thermoplastic polyurethan (TPU) which is used for medical devices that are implantable with use with electrodes as well as ultrasound ([074]; specifically using materials with LCP and TPU or any combination as such). Furthermore, the heat bonding is not seen as critical as the specification states that these materials may be bonded in such a manner and therefore “heat bonding” is seen as product by process and if these two material are used together, they are seen as bonded together. The recitation of “LCP heat bonded to TPU” is regarded as a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the implantable device of Carpentier with the substrate materials of Peters. The motivation being substituting one known material silicone in a substrate for another (LCP/TPU or combination of both) for the predictable resulted of having a flexible substrate that is compatible with implantation.
Regarding claim 15, Carpentier discloses: wherein the pressure wave comprises a fundamental frequency in a range approximately from 10Hz to 10GHz (Column 28, lines 28-35; specifically that the frequencies of operation for the ultrasound transducers are in a range of 1 kHz – 100 MHz which lie within the range as claimed and there for discloses the limitation of the claim), the pressure wave being configured to propagate a body part under the skin (Fig. 2; propagation of ultrasound toward the brain).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier and Peters further in view of Pak et al., “Thin Film Encapsulation for LCP-Based Flexible Bioelectronic Implants; Comparison of Different Coating Material Using Test Methodologies for Life-Time Estimation”, Micromachines, 2022, Vol. 13, NO. 544, pg 1-14, herein referred to as “Pak” (provided by applicate in prior art/IDS).
Regarding claim 16, Carpentier, Peters and Bakker do disclose that there are a plurality of sheets for the substrate (Carpentier; Figs 3-6 and column 12; specifically the two sheets) the sheet or sheets of the substrate can be 1-4 mm in thickness that each sheet can be in the thickness range of 5 µm to 3 mm (Carpentier, Column 14, lines 35-40; specifically the holder (with transducers encases as seen in Fig. 1 and 3-6) 1-4 mm which is seen as laying within the range as claimed and therefore teaching the claim), And that the substrate is made up of LCP (Peters; [074]; specifically using materials with LCP and TPU or any combination as such) Carpentier and Peters do not explicitly disclose that the substrate comprises a plurality of LCP sheets.
Pak discloses: However, that LCP can be used as a substrate material (abstract, page 2; specifically the flexible substrate can be made of LCP for fully implantable bioelectronic devices) and wherein the LCP of the substrate comprises a plurality of LCP sheets (Introduction: In this paper, to the best of our knowledge, we investigate for the first time the feasibility of using TFE materials with a silicone elastomer finish as a packaging solution for LCP-based implantable bioelectronics. Toward this goal, and as a first step, pre-screening tests were carried out to evaluate the interface adhesion of the TFE materials to LCP sheets – where sheets is seen as a plurality of sheets as sheets is plural of sheet and plurality means more than one and the use of the terminlology sheets is seen as having more than one LCP sheet).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the silicone sheets as taught by Carpentier to include the LCP as taught by Pak. The motivation being to replace one known biocompatible material (Silicone) with another (LCP) with the predictable result of using a material for a substrate that is able to house transducers and still reside in the brain.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier and Peters further in view of Tyler US 20120289869, herein referred to as “Tyler”.
Regarding claim 17, Carpentier and Peters do not explicitly disclose that there are EEG electrodes being used with the ultrasonic device. However, Tyler discloses: wherein the subcutaneous device further comprises one or more EEG electrodes configured to obtain an EEG signal ([0063]; specifically monitoring EEG from the brain using EEG electrodes [0113]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the transcranial device as taught by Carpentier and Peters to include the electrodes as taught by Tyler. The motivation being to monitor the brain activity during treatment (Tyler, [0113]).
Regarding claim 18, Carpentier and Peters do not explicitly disclose that there are EEG electrodes being used with the ultrasonic device. However, Tyler discloses: wherein each EEG electrode of the one or more EEG electrodes is disposed between adjacent transducers (Fig. 5, specifically EEG device/sensor which includes electrodes is between two transducers which are seen as adjacent and [0130], [0117]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the transcranial device as taught by Carpentier and Peters to include the electrodes as taught by Tyler. The motivation being to monitor the brain activity during treatment (Tyler, [0113]).
Regarding claim 19, Carpentier and Peters do not explicitly disclose that is a window into the skull. However, Tyler discloses: further comprising a window replacing at least a portion of the skull, the window having a higher transparency than the skull, configured to allow the ultrasound signals from the transducer to pass through with less scattering of the ultrasound signals than the skull ([0136] and [0153]; specifically the cranial window that still allows ultrasound to transmit through the skull which is seen as higher transparency as skull as it is a window).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the transcranial device as taught by Carpentier and Peters to include the window as taught by Tyler. The motivation being to utilize a known device (the window) in a known way (allowing for ultrasound to pass and have direct access to the brain) to allow for the predictable result of ultrasound passing into the brain of the user.
Allowable Subject Matter
Claims 9-13 would be allowed if they overcome the 112(a) on record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOANNE M RODDEN whose telephone number is (303)297-4276. The examiner can normally be reached Monday - Friday 9:00 AM-5:00 PM MST.
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/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794