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 .
Election/Restrictions
Claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups II-III, there being no allowable generic or linking claim. Because the Applicant has not specified whether election was made with or without traverse in the Reply, the Examiner will assume that the election was made without traverse in the reply filed on April 15th, 2026.
Applicant’s election without traverse of Group I (Claims 1-10) in the reply filed on April 15th, 2026 is acknowledged.
Drawings
The drawings are objected to because of the following informalities:
On Page 1 of the Drawings, Figure 2 is not properly labeled, as the indicator “FIG. 2” is on top of Page 2, which could be confused as indicating Figure 3 as Figure 2. In order to correct this issue, “FIG. 2” should be located at the bottom of Page 1 instead
On Page 2 of the Drawings, Figure 5 is not properly labeled, as the indicator “FIG. 5” is on top of Page 3, which could be confused as indicating Figure 6 as Figure 5. In order to correct this issue, “FIG. 5” should be located at the bottom of Page 2 instead
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 2 Line 30 currently recites “continuously._However”, but should read “continuously. However”
Page 7 Line 17 currently recites “sensor, and”, but should read “sensor), and”
Page 13 Line 31 currently recites “Figure10”, but should read “Figure 10”
Page 21 Line 14 currently recites “CDC)-, which”, but should read “CDC) – which”
Appropriate correction is required.
Claim Objections
Claim 4 is objected to because of the following informality:
Claim 4 recites “capacitively coupled said electronic circuit” in lines 2-3, but should read “capacitively coupled to said electronic circuit”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-10 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 recites the limitation "the absolute pressure" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the power associated" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the capsule body" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites “the flexible portion of the capsule” in lines 2-3. It is unclear as to whether this limitation is referring to the previously introduced “partially flexible portion” from Claim 1, or a separate element. Furthermore, it is unclear as to whether the Applicant meant for the term “partially” to modify “flexible” or to modify the portion in Claim 1. Currently, the Examiner is interpreting for the term “partially” to modify “flexible” in the current claim limitations.
Claim 3 recites the limitation "the electrical circuit" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the power transferring stage" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the flow" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the load" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "reading it" in line 9. It is unclear as to what “it” is referring to. Clarification is requested.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over NPL Pascual (Pascual Durall, Mar. "Roadmap for identifying clinical needs in technology-driven innovations: The Senso-eAXON case." (2020).; cited by Applicant) in view of NPL Becerra (Becerra Fajardo, Laura. "Microcontrolled injectable stimulators based on electronic rectification of high frequency current bursts." (2016).; cited by Applicant) and Rowland et al (U.S. Publication No. 2016/324443; cited by Applicant).
Regarding Claim 1, NPL Pascual discloses a pressure sensor (Senso-eAXON; Page 20), adapted to be implanted inside a human or animal vessel for measuring pressure (“continuous measurement of arterial blood pressure…BP monitoring”; Pages 20-21), comprising:
a hermetic capsule (“Hermeticity”; Page 18) comprising at least a partially flexible portion (“Flexibility”; Page 17);
an electronic circuit housed in the capsule, said electronic circuit being adapted to generate an electrical transduction pressure signal dependent on the absolute pressure outside the capsule (Section 3.2.1.2; Pages 17-20);
an electrode pair (“Two electrodes”; Page 18) electrically connected to the electronic circuit.
NPL Pascual fails to specifically disclose wherein each electrode of the electrode pair is, at least in part, arranged externally to the capsule, wherein the electronic circuit comprises: a digital control unit; an interrogation stage adapted to receive an interrogation signal transmitted by volume conduction to the electrode pair; to process said interrogation signal by means of the digital control unit; to generate, in response to the interrogation signal, the electrical transduction pressure signal; and to transmit, in response to the interrogation signal, said electrical transduction pressure signal to a medium by volume conduction, through the electrode pair; a power transfer stage adapted to receive at least part of the interrogation signal transmitted by volume conduction to the electrode pair, and to transfer the power associated to said at least part of the interrogation signal to the digital control unit and to the interrogation stage.
In a similar technical field of eAXON technology, NPL Becerra discloses microcontrolled injectable stimulators based on electronic rectification of high frequency current bursts, wherein each electrode of the electrode pair is, at least in part, arranged externally to the capsule (“Two external electrodes strapped around the edges of the cylinder”; Figure 2.7; Page 49), wherein the electronic circuit comprises:
a digital control unit (Figure 2.3; Page 44);
an interrogation stage adapted to receive an interrogation signal (1 MHz current) transmitted by volume conduction to the electrode pair (“A full-bridge rectifier implemented with Schottky diodes (MCL103B-TR by Vishay Intertechnology, Inc.) provides full-wave rectification of the ac voltage picked up by the implant electrodes”; Page 44);
to process said interrogation signal by means of the digital control unit (“Demodulation circuit…Digital control system”; Pages 44-45);
to generate, in response to the interrogation signal, the electrical transduction pressure signal (“a basic electronic architecture for addressable wireless stimulators made of commercial components and based on the proposed eAXON method…to use these addressable implants in a neural interface platform for closed-loop neuroprosthetic systems, it would be highly beneficial to include sensing features within the wireless implants. There are a few cases of microstimulators that include sensors”; Page 75); and
to transmit, in response to the interrogation signal, said electrical transduction pressure signal to a medium by volume conduction, through the electrode pair (“the basic electronic architecture proposed for the implants in Chapter 2 is capable of modulating the auxiliary 1 MHz current coming from the external system, and this modulated signal can be read by an external receiver. Thereby, a wireless uplink connection can be created between the implantable circuits and external system. Trials were performed in which digital bytes were effectively sent to and echoed by the circuit prototype, demonstrating the bidirectional communication capabilities of the proposed system. The wireless bidirectional communication system presented here is a first step towards the conceived concept of network of wireless microstimulators based on electronic rectification of HF current bursts”; Page 84);
a power transfer stage (rectifier) adapted to receive at least part of the interrogation signal transmitted by volume conduction to the electrode pair (implant electrodes 1 and 2), and to transfer the power associated to said at least part of the interrogation signal to the digital control unit and to the interrogation stage (“1.4.3. Galvanic coupling as means for HF current conduction”; Pages 20-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the circuitry teachings of NPL Becerra into those of NPL Pascual in order to implement the eAXON method, which has the potential to accomplish a miniaturization level without precedents for implantable medical devices since the implants lack typical bulky parts as coils (used for inductive coupling) and batteries, wherein the implants consist of electronic components that can be implemented in a single integrated circuit or hybrid microcircuit connected to two electrodes in a flexible body.
NPL Pascual and NPL Becerra fail to specifically disclose wherein said electronic circuit being adapted to generate an electrical transduction pressure signal resulting from a deformation of the partially flexible portion of the capsule.
In a similar technical field, Rowland teaches a pressure sensing implant (Abstract), wherein said electronic circuit being adapted to generate an electrical transduction pressure signal resulting from a deformation of the partially flexible portion of the capsule (“implant 10 contains a pressure sensor 40, the internal electronic components may include one or more pressure sensors such as MEMS pressure sensor components and the top wall 60 may be a diaphragm such as a flexible membrane. The top wall 60 and electrodes 46A, 46B may communicate pressure by slight vibrations. Also, a gas, a fluid, or a gel may fill the cavity 25 formed by the housing 20. In another embodiment, the bottom wall 50 may also be a diaphragm such as a flexible membrane which may include additional electrical components that may also be part of a sensing electronic circuit (not shown). In either embodiment, pressure measurements may be transduced directly into an electronic signal of a sensing circuit or component”; [0062]; “In the embodiment, shown in FIGS. 1, 3 and 4, the top wall 60 (and in some embodiments, the bottom wall 50) may serve as flexible pressure diaphragms, which communicate pressure to chip-scale pressure sensors on internal electronics through a pressure-communicating medium”; [0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the flexible teachings of Rowland into those of NPL Pascual and NPL Becerra in order to communicate pressure by slight vibrations to pressure sensors on internal electronics through a pressure-communicating medium (Rowland [0062] and [0082]).
Regarding Claim 2, NPL Pascual and NPL Becerra fail to specifically disclose wherein the capsule body is made, at least in part, of metallic material.
In a similar technical field, Rowland teaches a pressure sensing implant (Abstract), wherein the capsule body is made, at least in part, of metallic material (“The implant 10 may include a housing 20 that may utilize thin membrane materials such as glass, quartz, sapphire, fused silica, alumina, titanium, diamond, or other materials”; [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the material teachings of Rowland into those of NPL Pascual and NPL Becerra, as metallic materials are electrically conductive which benefit systems in which power or signal transfer are at high frequencies, or implemented using other wireless energy transfer means such as ultrasonic, acoustic, etc. (Rowland [0047]).
Regarding Claim 3, NPL Pascual and NPL Becerra fail to specifically disclose a pressure transmission fluid housed inside the capsule, wherein the fluid is arranged between the flexible portion is of the capsule and the electronic circuit, and wherein the electrical circuit further comprises a pressure transducer.
In a similar technical field, Rowland teaches a pressure sensing implant (Abstract), comprising a pressure transmission fluid housed inside the capsule, wherein the fluid is arranged between the flexible portion is of the capsule and the electronic circuit, and wherein the electrical circuit further comprises a pressure transducer (“implant 10 contains a pressure sensor 40, the internal electronic components may include one or more pressure sensors such as MEMS pressure sensor components and the top wall 60 may be a diaphragm such as a flexible membrane. The top wall 60 and electrodes 46A, 46B may communicate pressure by slight vibrations. Also, a gas, a fluid, or a gel may fill the cavity 25 formed by the housing 20. In another embodiment, the bottom wall 50 may also be a diaphragm such as a flexible membrane which may include additional electrical components that may also be part of a sensing electronic circuit (not shown). In either embodiment, pressure measurements may be transduced directly into an electronic signal of a sensing circuit or component”; [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the flexible teachings of Rowland into those of NPL Pascual and NPL Becerra in order to communicate pressure by slight vibrations to pressure sensors on internal electronics through a pressure-communicating medium (Rowland [0062] and [0082]).
Regarding Claim 4, NPL Pascual and NPL Becerra fail to specifically disclose wherein the partially flexible portion of the capsule is electrically connected to the electronic circuit and capacitively coupled said electronic circuit through a conductor, forming a pressure transducer whose capacitance depends on the deformation of the partially flexible portion of the capsule.
In a similar technical field, Rowland teaches a pressure sensing implant (Abstract), wherein the partially flexible portion of the capsule is electrically connected to the electronic circuit and capacitively coupled said electronic circuit through a conductor, forming a pressure transducer whose capacitance depends on the deformation of the partially flexible portion of the capsule (“The sensor 40 may be a capacitive pressure sensor, wherein the diaphragm 60 may be designed to flex slightly and change the height of gap 64 when the top surface 68 and bottom surface 62 of sensor 40 are exposed to different pressures. The sensor 40 may be a force or strain sensor, wherein the diaphragm 60 may be designed to flex and change the gap 64 height when exposed to force or strain”; [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the flexible teachings of Rowland into those of NPL Pascual and NPL Becerra in order to communicate pressure by slight vibrations to pressure sensors on internal electronics through a pressure-communicating medium (Rowland [0062] and [0082]).
Regarding Claim 6, NPL Pascual fails to specifically disclose a fixation means adapted for attaching the sensor to a vessel.
In a similar technical field of eAXON technology, NPL Becerra teaches a fixation means adapted for attaching the sensor to a vessel (Figure 2.3, 2.7, and 5.2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the sensor teachings of NPL Becerra into those of NPL Pascual in order to enable the signals to be obtained through an in vitro setup comprising of an implantable probe.
Regarding Claim 7, NPL Becerra teaches wherein the fixation means comprise the electrode pair (Figures 2.3, 2.7, and 5.2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the sensor teachings of NPL Becerra into those of NPL Pascual in order to enable the signals to be obtained through an in vitro setup comprising of an implantable probe.
Regarding Claim 8, NPL Becerra teaches wherein the electrode pair or the fixation means comprise at least one of the following: a stent structure, a cable structure, or a wire loop structure. (Figures 2.3, 2.7, and 5.2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the sensor teachings of NPL Becerra into those of NPL Pascual in order to enable the signals to be obtained through an in vitro setup comprising of an implantable probe.
Regarding Claim 9, NPL Pascual fails to specifically disclose wherein the capsule and/or the electrode pair at least in part, covered with insulating material.
In a similar technical field of eAXON technology, NPL Becerra teaches wherein the capsule and/or the electrode pair at least in part, covered with insulating material (“The probe consisted of a 1.8 mm diameter coaxial cable (50CX-41 by Temp-Flex Cable Inc.) whose core and shield conductors were contacted to two 3.8 mm long, 2 mm thick stainless steel electrodes separated by a 41 mm long fluorinated ethylene propylene (FEP) insulator”; Page 97).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the insulator teachings of NPL Becerra into those of NPL Pascual, as insulators provide safety advantages, avoids short circuits, and reduce power losses.
Regarding Claim 10, NPL Pascual fails to specifically disclose wherein the power transferring stage of the electronic circuit comprises a blocking capacitor connected in series with the electrode pair, adapted so as to prevent passage of dc current and to enable the flow of high frequency current to and from the electronic circuit, and wherein the interrogation stage a demodulator unit to compare low-pass filtered signals obtained with a rectifier and a digital converter connected to a sensing capacitor to a piezoresistive pressure sensor; and wherein the digital control unit adapted to generate an electrical transduction pressure signal by modulating the load of the pressure sensor and reading it with the digital converter.
In a similar technical field of eAXON technology, NPL Becerra teaches wherein the power transferring stage of the electronic circuit comprises a blocking capacitor connected in series with the electrode pair, adapted so as to prevent passage of dc current and to enable the flow of high frequency current to and from the electronic circuit, and wherein the interrogation stage a demodulator unit to compare low-pass filtered signals obtained with a rectifier and a digital converter connected to a sensing capacitor; and wherein the digital control unit adapted to generate an electrical transduction pressure signal by modulating the load of the pressure sensor and reading it with the digital converter (2.2.2. Electronic circuitry; Pages 44-46; Figure 2.3; The stimulation systems described up to this point are open-loop systems: preprogrammed stimulation patterns are executed on command. By implementing uplink communications (from the microstimulators to the external system), it is possible to conceive closed-loop systems in which the stimulation signals are modulated in response to measurements performed with the implants; Pages 61-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the circuitry teachings of NPL Becerra into those of NPL Pascual in order to implement the eAXON method, which has the potential to accomplish a miniaturization level without precedents for implantable medical devices since the implants lack typical bulky parts as coils (used for inductive coupling) and batteries, wherein the implants consist of electronic components that can be implemented in a single integrated circuit or hybrid microcircuit connected to two electrodes in a flexible body.
NPL Pascual and NPL Becerra fail to specifically disclose a piezoresistive pressure sensor.
In a similar technical field, Rowland teaches a pressure sensing implant (Abstract), comprising a piezoresistive pressure sensor (Minor variations to the basic design of the sensor 40 may be effected, to create other sensor types. Removing the base 80 may create a chemical sensor or a proximity sensor, wherein the top electrodes 46A may form an in-plane capacitor whose capacitance changes when the dielectric constant of the environment outside the top plate 60 changes, or when an object that affects capacitance (for example a metal object) gets sufficiently close to top plate 60. Patterning piezoresistive transducing elements onto diaphragm 60 may form a resistive type of sensor, which may transduce changes in diaphragm shape due to pressure, temperature, or strain into resistive changes; [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the piezoresistive teachings of Rowland into those of NPL Pascual and NPL Becerra in order to transduce changes in diaphragm shape due to pressure, temperature, or strain into resistive changes (Rowland [0052]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over NPL Pascual, NPL Becerra, and Rowland, as applied to claim 1 above, and further in view of Endotronix (U.S. Publication No. 2016/029956; cited by Applicant).
Regarding Claim 5, NPL Pascual, NPL Becerra, and Rowland fail to specifically disclose wherein said sensor comprises two conductors, and wherein the electronic circuit is capacitively coupled to the capsule through said conductors, forming two pressure transducers connected in series.
In a similar technical field, Endotronix teaches a pressure sensing implant (Abstract), wherein said sensor comprises two conductors, and wherein the electronic circuit is capacitively coupled to the capsule through said conductors, forming two pressure transducers connected in series (“FIG. 8 shows a cross sectional view of an example capacitive pressure sensor 800. While the capacitive pressure sensor 800 shown suggests a series capacitor design,…such a capacitive pressure sensor 800 and derivations thereof may be particularly useful for forming a wireless pressure sensor and integrated with an implant housing”; [0091]; Figure 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the series capacitor design teachings of Endotronix into those of NPL Pascual, NPL Becerra, and Rowland in order to provide improved power transfer and voltage regulation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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