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 .
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.
This application includes one or more claim limitations that use the word “means.” Such claim limitation(s) is/are:
“transmission means” in claim 9, whose corresponding structure is “the transmission means 110 may consist of a transmitter/receiver of electromagnetic waves such as radio waves, Bluetooth, WIFI, etc. Under certain specific conditions, the transmission means 110 may be wired” (WO 2023/186817 A1, Paragraph 0076).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re. Claim 5: Claim 1 recites “the sensitive cell being arranged in contact with the gas contained in the internal volume of the measuring chamber” [emphasis added]. As best understood, this is shown at Applicant’s Figs. 2, 5, where no sealing membrane is shown as being interposed between the sensing cell and the internal volume of the measuring chamber, allowing for contact between the sensitive cell and the gas.
Claim 5 requires a structure interposed between the sensitive cell and the internal volume of the measuring chamber, which prevents the sensitive cell from contacting the gas within the measuring chamber. This is best illustrated in Applicant’s Fig. 1. Thus, it is unclear how a sealing membrane is interposed between the sensitive cell and the internal volume of the measuring chamber to protect the sensitive cell, when a sensitive cell is intended to contact the gas within the internal volume of the measuring chamber as recited in claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 6, 9, 11, 12, and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Hu et al. (WO 2015161102 A1) (hereinafter – Hu).
Re. Claim 1: Hu teaches a measuring device for measuring at least one physiological parameter (Paragraph 0002: “The present invention is directed to the field of implantable medical devices, and more specifically, medical devices for monitoring physiological parameters of a subject head”),
the measuring device including a housing that extends longitudinally between a first end and a second end opposite the first end (Figs. 5A-10B),
the housing comprises:
- a measuring chamber which is arranged in the housing (Figs. 6, 7: chamber formed by catheter 12 and element 16; Fig. 10B: chamber formed by catheter 812 and neck 850 and/or catheter junction 811, which may be formed from luer lock fitting as described in Paragraph 0096),
the measuring chamber has an internal volume which is filled with gas (Paragraph 0061: “During the course of implantation, catheter 12, if originally filled with a medium or media either during manufacture or at the implantation site, can become partially or fully displaced with intracranial fluid;” Paragraph 0085: “Catheter 812 can provide a fluid or gas column from the target measurement area to the sensing diaphragm (e.g., diaphragm 820 illustrated in FIG. 10B)”),
- a sensitive cell making it possible to measure at least a first physiological parameter, the sensitive cell being arranged in contact with the gas contained in the internal volume of the measuring chamber (Fig. 5B: pressure sensing diaphragm 20 and sensors 22, as described at Paragraph 0047: “Sensors 22 are disposed within the second internal cavity 25 to detect presence or magnitude of diaphragm 20 deflection caused by pressure on the external side of diaphragm 20;” Fig. 10B: pressure sensing diaphragm 820 and sensors 822), and
- an inlet for the intake of a physiological liquid of a patient into the measuring chamber (Fig. 5B: apertures 53, as described at Paragraph 0061: ”In some embodiments, pressure can be conducted from a measured region of tissue through ports 53, 55 (which can be perforations, apertures, windows, holes, punctures, etc.) at distal end 52 of catheter 12 through the gas, liquid, gel or solid medium within the inner lumen of the catheter 12 up to diaphragm 20;” additionally or alternatively, Figs. 9-10B: catheter junction 811, described at Paragraph 0096: “Catheter 812 can attach to catheter junction 811 by epoxy, press-fit, screw fit, luer lock fitting, and/or any other connection”),
wherein the inlet is arranged such that the physiological liquid comes into contact with the gas and the gas is interposed between the sensitive cell and the physiological liquid of the patient, the measuring chamber making it possible to generate two interfaces:
a first interface between the gas contained in the internal volume and the physiological liquid of the patient which enters the measuring chamber through the inlet, and
a second interface between the gas contained in the measuring chamber and the sensitive cell
(Fig. 6, as described in Paragraph 0061: “The fluid can enter due to catheter 12 insertion, capillary action along the inner surface of catheter 12, rise in intracranial pressure, or other reasons. In some cases, if catheter 12 is initially filled with a medium or media, invasion of intracranial fluid or gas can trap and possibly compress a volume of the media in proximal end 44 of catheter 12”).
Re. Claim 5: Hu teaches the invention according to claim 1. Hu further teaches the invention wherein the housing comprises a sealing membrane which is interposed between the sensitive cell and the internal volume of the measuring chamber, the sealing membrane protecting the sensitive cell (Fig. 5B: diaphragm 20 can be considered a sealing membrane between the space containing the sensor 22, i.e., a sensing cell, and the internal volume of the measuring chamber, i.e., Figs. 6, 7: chamber formed by catheter 12 and element 16; Fig. 10B: chamber formed by catheter 812 and neck 850 and/or catheter junction 811).
Re. Claim 6: Hu teaches the invention according to claim 1. Hu further teaches the invention wherein the internal volume of the measuring chamber is cylindrical (Figs. 5A-6, 9-10B: entirety of implant appears cylindrical).
Re. Claim 9: Hu teaches the invention according to claim 1. Hu further teaches the invention comprising transmission means which transmit the measurements of the first physiological parameter to a remote digital terminal (Fig. 4: transceiver 4, receiver interface 6; Paragraph 0068: wireless communication and telemetry to transmit sensor data).
Re. Claim 11: Hu teaches the invention according to claim 1. Hu further teaches the invention wherein the sensitive cell is arranged at the first end of the housing, while the inlet is arranged at the second end of the housing (Fig. 5B: sensor 22 and diaphragm 20 located at end identified by region 25, and ports 53 are arranged at distal end of catheter 12).
Re. Claim 12: Hu teaches a measuring method for measuring at least one physiological parameter of a patient, characterized in that the method comprises:
- a connection step of connecting a measuring chamber connection device to the physiological liquid of a patient (Fig. 7: implantation of catheter 12 skull 102; Paragraph 0061: catheter is configured to uptake at least some degree of fluid, and thus is understood to be in contact with physiological fluid when implanted),
the measuring chamber being filled with gas and comprising a sensitive cell making it possible to measure at least one physiological parameter (Paragraph 0061),
- a generation step of generating a first interface between the gas present in the measuring chamber and the physiological liquid coming from the patient, the gas being interposed between the physiological liquid and the sensitive cell in such a way as to form a second interface between the gas and the sensitive cell (Paragraph 0061: see partial displacement of media in catheter 12), and
- a measurement step of measuring at least a first physiological parameter, the measurement being carried out by the sensitive cell through the gas interposed between the physiological liquid and the sensitive cell (Paragraph 0047: “Sensors 22 are disposed within the second internal cavity 25 to detect presence or magnitude of diaphragm 20 deflection caused by pressure on the external side of diaphragm 20;” Paragraph 0035: “FIG. 1 illustrates a high-level flowchart of an example method of monitoring a physiological parameter, which as used herein can include, without limitation, ICP, intracranial temperature, subject head position, orientation, oxygen levels, pH, and the like”).
Re. Claim 14: Hu teaches the invention according to claim 12. Hu further teaches the invention wherein the measuring chamber is connected to a device for connection to the physiological liquid which includes cerebrospinal fluid of a patient (Fig. 5b: see components of implant body 8 above sensor Abstract: device monitors intracranial pressure; Examiner notes that cerebrospinal fluid surrounds the brain, whereby its hydraulic pressure is a component of total intracranial pressure).
Re. Claim 15: Hu teaches the invention according to claim 12. Hu further teaches the invention wherein the first physiological parameter corresponds to a pressure of the physiological liquid of the patient (see rejection of claim 14).
Re. Claim 16: Hu teaches the invention according to claim 1. Hu further teaches the invention comprising a determination step of determining at least a second physiological parameter through the measurement of the first physiological parameter (Paragraphs 0051, 0113, 0116: physiological measurements are compensated to provide more accurate physiological measurements).
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.
Claims 2, 3, 13, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over:
Hu et al. (WO 2015161102 A1) (hereinafter – Hu).
Re. Claim 2: Hu teaches the invention according to claim 1, but does not explicitly teach the invention wherein the measuring chamber has an internal volume that is non-zero and less than or equal to 1 ml.
The purpose of such dimensions for an internal volume appears to be to minimize signal damping (see WO 2023/186817 A1, Paragraph 00135; Fig. 11). Hu also considers the prevention of dampening when considering the construction of the device (Paragraphs 0060-0061). Additionally, Hu also states that the implant can be provided with catheters of varying lengths, shapes, and sizes and/or geometries depending on monitoring modality (Paragraph 0062). Hu also provides general dimensional ranges of the catheter itself (Paragraph 0060), and also states that the volume of the catheter may be partially displaced with intracranial fluid. Thus, Hu teaches conditions which allow for a measuring chamber whose dimensions encompass Applicant’s invention.
Absent a teaching of criticality or unexpected results of requiring the internal volume being at the claimed ranges, it would have been within the skill level of the art before the effective filing date of the claimed invention to determine optimized values for the measuring chamber dimensions, since it has generally been held to be within the skill level of the art to perform routine experimentation to determine optimal operation parameters, as suggested by the ranges of catheter dimensions and use cases disclosed in Hu.
Re. Claim 3: Hu teaches the invention according to claim 1, but does not explicitly teach the invention wherein the measuring chamber has an internal volume between 0.2 ml and 0.5 ml. See rejection of claim 2; Hu teaches the requirements of claim 3 via the same rationale.
Re. Claim 13: Hu teaches the invention according to claim 12, but does not explicitly teach the invention wherein the gas interposed between the sensitive cell and the physiological liquid of the patient has a volume that is non-zero and less than or equal to 1 ml. See rejection of claim 2; Hu teaches the requirements of claim 13 via the same rationale.
Re. Claim 17: Hu teaches the invention according to claim 2, but does not explicitly teach the invention wherein the measuring chamber has an internal volume that is less than 0.7 ml. See rejection of claim 2; Hu teaches the requirements of claim 17 via the same rationale.
Re. Claim 18: Hu teaches the invention according to claim 13, but does not explicitly teach the invention wherein the gas interposed between the sensitive cell and the physiological liquid of the patient has a volume that is less than 0.7 ml. See rejection of claim 2; Hu teaches the requirements of claim 18 via the same rationale.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over:
Hu et al. (WO 2015161102 A1) (hereinafter – Hu) in view of
Burger et al. (US 20110040206 A1) (hereinafter – Burger).
Re. Claim 4: Hu teaches the invention according to claim 1, but does not teach the invention wherein the sensitive cell is a piezoelectric cell of a pressure sensor. Hu instead states that “sensors can include optical sensors, strain gauges, capacitive sensors, Hall Effect sensors, and the like, and can measure stress and/or strain and/or deflection of the pressure-sensing diaphragm” (Paragraph 0008).
Burger teaches analogous art in the technology of pressure sensing devices (Title; Abstract). Burger further teaches the invention wherein the sensitive cell is a piezoelectric cell of a pressure sensor (Paragraph 0014: two prior art examples utilizing a deformable membrane and a piezoelectric transducer for detecting deformation; Paragraph 0053: alternative constructions of piezoelectric pressure sensor comprising a membrane).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is, in the substitution of a piezoelectric sensor of Burger for the pressure sensor of Hu. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over:
Hu et al. (WO 2015161102 A1) (hereinafter – Hu) in view of
Morse et al. (US 20230132409 A1) (hereinafter – Morse).
Re. Claim 7: Hu teaches the invention according to claim 1. The inlet identified in Hu are ports of a catheter (Fig. 6: port 53; Fig. 9: port 853), which do not possess a connector sealingly connecting the measuring chamber to a connecting device for connection to the physiological liquid of the patient.
Morse teaches analogous art in the technology of pressure sensor assemblies having direct communication with body fluid (Paragraph 0007). Morse further teaches the invention comprising a connector arranged at the inlet of the housing, the connector sealingly connecting the measuring chamber to a connecting device for connection to the physiological liquid of the patient (Fig. 6: catheter 107a having fluid-tight connector 106 prior to pressure sensor assembly 104a; Paragraph 0067: connector 106 may be a stop-cock).
It would have been obvious to one having skill in the art before the effective filing date to have modified Hu to include a connector such as a valved stopcock as taught by Morse, the motivation being that doing so enables allows a user to stop fluid flow to the measuring device in the scenario that a user intends to cease measurement, and also allow the portion of the catheter still implanted to be utilized with another device by removing the device connected at the point of the stopcock.
Re. Claim 8: Hu teaches the invention according to claim 1. The inlet identified in Hu are ports of a catheter, which are not closable. However, in Morse teaches the use of a stopcock in-line with a catheter (see rejection of claim 7), which may also be considered an inlet.
It would have been obvious to one having skill in the art before the effective filing date to have modified Hu to include the stopcock as taught by Morse in-line with a catheter, the motivation being identical to those recited in the rejection of claim 7.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over:
Hu et al. (WO 2015161102 A1) (hereinafter – Hu) in view of
Stimpson et al. (US 20160029912 A1) (hereinafter –Stimpson).
Re. Claim 10: Hu teaches the invention according to claim 1, but does not explicitly teach wherein the gas in the measuring chamber includes atmospheric air. Hu states that “[t]he gas can be any suitable gas” (Paragraph 0008).
Stimpson teaches analogous art in the technology of catheter-based pressure sensors (Abstract). Stimpson further teaches the invention wherein the gas in the measuring chamber includes atmospheric air (Paragraph 0003: “Pressure sensing catheters are known in the art by way of example from U.S. Pat. No. 5,573,007 which describes a gas-column pressure measuring catheter for use intravenously or in a bladder to measure the pressure of the fluid in those body areas. The catheters have a gas-filled lumen communicating with a membrane-walled chamber on the catheter body. Pressure changes exerted against the outer surface of the membrane walled chamber result in the transmission of pressure changes through the gas-filled catheter lumen. The membrane walled chamber may be located on the side wall of the catheter body or at the distal end of the catheter body. A gas-column pressure measuring sensor is provided at a proximal end of the catheter through an electronic sensor. The air-column of the catheter is in direct fluid communication with the sensor”).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is, in the substitution of atmospheric air in the gas column of a pressure-sensing catheter as taught by Stimpson for the gas utilized in the analogous catheter of Hu. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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