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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/13/2024 was received in placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “control module…configured to drive the plurality of oils of the coil set to perform an eddy current induction measurement on a target vessel to derive a plurality of sensing signals corresponding to the plurality of coils” in claim 1-10.
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.
In the instant case, the “control module” is being interpreted as described in paragraphs [0022] and [0023] of the applicant’s submitted specification.
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.
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.
Claim 9 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.
Specifically, claim 9 recites the limitation “the matching component has a magnetic impedance between a magnetic impedance of the measurement surface and a magnetic impedance of a medium at an outer side of the target vessel”, which is indefinite. The limitation is indefinite because the scope of the claim cannot be determined as the claimed range for the “magnetic impedance” is variable depending on the material of the measurement surface and the outer surface of the target vessel, which are not positively claimed. Said another way, reference to an object that is variable may render the claim indefinite (see MPEP 2173.05(b) II.), which in that case it does because the outer surface of the target vessel is variable depending on where the handheld vascular state measurement device is being used. As such, we cannot determine the scope of the claim. The examiner encourages the applicant to amend the claim to functionally recite the matching component in order to overcome this claim similar to as recited in paragraph [0029] of the spec. For example, “the matching component is configured to reduce energy loss during the transmission of the electromagnetic signals and/or the feedback electromagnetic signals” or similar so as to claim the function of the matching component without reciting the variable range which is indefinite.
For the purpose of advancing prosecution, the examiner will interpret the limitation of “the matching component has a magnetic impedance between a magnetic impedance of the measurement surface and a magnetic impedance of a medium at an outer side of the target vessel” to be: any matching component that provides any one of the functions recited in paragraph [0029] comprising: reducing energy loss during transmission of the electromagnetic signals and/or feedback electromagnetic signals; improving the signal-to-noise ration with lower energy; or reducing safety issues such as excessive energy causing injury to the subject.
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 1-3, 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Leijssen et al (WO 2018/108850 A1, hereinafter “Leijssen”) in view of Feldkamp et al (US 2010/0219841 A1, hereinafter “Feldkamp”) and Feldkamp et al (US 2010/0222696 A1, hereinafter “Heller”).
Regarding claims, 1-3, 6 and 8-10; Leijssen discloses a handheld vascular state measurement device (page 13, line 16-19), comprising:
a handheld part (page 13, lines 16-19);
a coil set (elements 42) arranged on a measurement surface (figure 2-6), the coil set including a plurality of coils (wherein the magnetic generating elements are a plurality of coils; pages 8, line 1 – page 11, line 20; figures 2-5); and
a control module (element 46) coupled to the coil set, wherein the control module is configured to drive the plurality of coils of the coil set to perform an eddy current induction measurement on a target tissue to derive a plurality of sensing signals corresponding to the plurality of coils (column 11, line 16 – page 12, line 21; page 14, line 1 – page 16, line 6; figure 7)
wherein two of the plurality of sensing signals have a signal characteristic difference, and the control module evaluates at least one vascular state of the target vessel based on the signal characteristic difference (page 8, line 1 – page 12, line 31, page 14, line 1 – page 16, line 6; figures 2-5 and 7, specifically figure 7).
Leijssen fails to explicitly disclose the specifics of the handheld structure including a shell having a probe part and a handheld part; or that the control module evaluates at least a vascular state of a target vessel based on the signal difference.
Feldkamp teaches a similar handheld vascular measurement device which uses a sensor which utilizes magnetic coils to induce a magnetic field on a body tissue that teaches the structure and placement of the components of the vascular measurement device in a handheld unit comprises a shell (housing element 20; figures 1a) having a probe part (part of housing comprising sensing elements 10, 12 and 15 for placement against body; figures 1a and 1b) and a handheld part (part of housing with grip elements 22 for holding; paragraph [0040]; figures 1a, 2).
Regarding claim 1, Leijssen discloses a handheld vascular state measurement device as described above; Feldkamp teaches a known handheld probe for a similar vascular state measurement device. It would have been obvious to one of ordinary skill in the art at the time of filing to modify Leijssen for use in the handheld probe structure as taught by Feldkamp to provide Leijssen handheld vascular statement measurement device having a probe part and a handheld part (Feldkamp) wherein the coil set (Leijssen) arranged in a measurement surface (probe part of Feldkamp) as combining prior art elements according to known methods to yield predictable results (in this case combining the prior art elements of Leijssen into the handheld probe structure as disclosed by Feldkamp).
The Leijssen/Feldkamp combination described above discloses utilizing the probe to measure the vascular state under the tissue, but does not explicitly disclose that the control module evaluates at least a vascular state of a target vessel based on the signal difference.
Heller, by the same inventors of Feldkamp, teaches the use of the handheld vascular measurement device specifically for evaluating the vascular state of a target vessel based on the measured signals (paragraphs [0034]-[0041], [0060]-[0066]; figures 1-3).
Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Leijssen/Feldkamp combination to further modify the control module of the handheld vascular measurement device to evaluate at least one vascular state of a target vessel based on the signal characteristic difference measured by Leijssen’s measurement coil system.
Further regarding claim 2; the Leijssen/Feldkamp/Heller combination as described in the rejection of claim 1 above. Leijssen further discloses the eddy current induction measurement includes: transmitting a plurality of electromagnetic signals to a plurality of detection locations of the target tissue, respectively; and receiving, by the plurality of coils, a plurality of feedback electromagnetic signals from the plurality of detection locations to obtain the plurality of sensing signals (Leijssen - page 8, line 1 – page 12, line 31, page 14, line 1 – page 16, line 6; figures 2-5 and 7, specifically figure 7). Heller teaches utilizing the induction sensor for detection on a target vessel. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Leijssen/Feldkamp/Heller combination as described in claim 1 would be utilized for detecting the eddy current induction measurement in a target vessel to determine a vascular state as taught by Heller.
Further regarding claim 3; Leijssen discloses the signal characteristic difference between the two of the plurality of sensing signals at least includes a frequency difference between the two of the plurality of sensing signals (wherein the examiner notes that the frequency of the phase shift provides the physiological characteristic measurement; page 14, line 1 – page 16, line 6; figures 2-5 and 7, specifically figure 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Leijssen/Feldkamp/Heller combination would also utilize frequency difference between the two of the plurality of sensing signals.
Further regarding claim 4; Leijssen discloses the signal characteristic difference between the two of the plurality of sensing signals at least includes a time delay between the two of the plurality of sensing signals (wherein the examiner notes time delay corresponds to the phase shift; page 14, line 1 – page 16, line 6; figures 2-5 and 7, specifically figure 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Leijssen/Feldkamp/Heller combination would also utilize the time delay between the sensing signals.
Further regarding claim 6; the examiner notes that the limitation “wherein the target vessel is a femoral artery” is an intended use recitation, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the examiner contends that the Leijssen/Feldkamp/Heller combination is capable for use on the femoral artery.
Further regarding claim 8; the Leijssen/Feldkamp/Heller combination as described in the rejection of claim 1 above but does not disclose an isolation component arranged at an outer side of the measurement surface, and the isolation component has a plurality of signal permeable portions corresponding to the plurality of coils.
Feldkamp further teaches an isolation component (protective coating) is arranged at an outer side of the measurement surface, and the isolation component has a plurality of signal permeable portions corresponding to the plurality of coils (wherein the examiner notes that the protective coating meets the BRI of an isolation component as it isolates the coils from the atmosphere and has signal permeable portions corresponding to the coils as it allows for the EM field to pass through the coating to reach the target tissue; paragraph [0046]-[0049]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Leijssen/Feldkamp/Heller combination to further include an isolation component arranged on an outer side of the measurement surface having a plurality of signal permeable portions corresponding to the plurality of coils as taught by Feldkamp in order to protect the coil array.
Further regarding claim 9; the Leijssen/Feldkamp/Heller combination as described in the rejection of claim 1 above but does not disclose a matching component is arranged at an outer side of the measurement surface, and the matching component reduces energy loss during transmission of the electromagnetic signals and/or feedback electromagnetic signals; improving the signal-to-noise ratio with lower energy; or reducing safety issues such as excessive energy causing injury to the subject (based on examiner’s interpretation of indefinite claim language, see 112(b) rejection provided above).
Feldkamp further teaches an a matching component (protective coating) is arranged at an outer side of the measurement surface, and the matching component (protective coating) reduces energy loss during transmission of the electromagnetic signals and/or feedback electromagnetic signals; improving the signal-to-noise ratio with lower energy; or reducing safety issues such as excessive energy causing injury to the subject (wherein the examiner notes that the protective coating meets the BRI of an matching component as it is made from an a dielectric material having a dielectric constant of less than about 10, such as less than 5, which improves the signal to noise ratio as the low dielectric contact help the electromagnetic signal conduct to the target tissue; paragraph [0046]-[0049]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Leijssen/Feldkamp/Heller combination to further include an isolation component (protective coating) arranged on an outer side of the measurement surface as taught by Feldkamp in order to provide a conductive and protective material which allows the electromagnetic field to be transmitted to the target tissue.
Further regarding claim 10; Feldkamp discloses the control modules is arranged inside the shell (housing element 20; paragraphs [0040], see figure 6). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing that the Leijssen/Feldkamp/Heller combination would also provide the control module arranged inside the shell of the handheld device.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Liejssen in view of Feldkamp and Heller as applied to claims 1 and 4 above, and further in view of Nagarkar et al (US 2016/0169838 A1, hereinafter “Nagarkar”)..
The Leijssen/Feldkamp/Heller combination is described in the rejections of claims 1 and 4 above; Liejssen further discloses two of the plurality of coils are arranged by a distance (coils are separated by distances, see figures 2-5); however it does not explicitly disclose wherein the control module evaluates, according to the time delay and the distance, an evaluated blood flow rate at a measurement region corresponding to the two of the plurality of coils (claim 5); or wherein the at least one vascular state includes an embolism level or a hardening level of the target vessel at a measurement region corresponding to the two of the plurality of coils (claim 7).
Nagarkar teaches a system for improved physiological monitoring utilizing a plurality of magnetic field generator coils arranged by a distance wherein a control module evaluates according to the time delay and the distance of the coils signals, an evaluated blood flow rate at a measurement region corresponding to the two of the plurality of coils and the at least one vascular state includes a hardening level of the target vessel at a measurement regions corresponding to the two of the plurality of coils (paragraphs [0020]-[0034], [0077]-[0078], [0080]-[0087]; figures 1, 2, 4 and 9).
Regarding claim 5; the Leijssen/Feldkamp/Heller combination discloses a vascular state measurement device utilizing a multiple coil magnetic field induction including at least two coils spaced apart by a distance and measuring the varying characteristics of the signals to determine physiological parameters of the body (see rejections of claims 1 and 4 above). Nagarkar teaches a similar setup using coils wherein the control module utilizes a that uses the measured signals according to the time delay and distance to evaluate a blood flow rate at a measurement region corresponding to the two of the plurality of coils. Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to modify the control module of the Leijssen/Feldkamp/Heller combination to utilize Nagarkar’s blood flow rate sensing technique in order to evaluate a blood flow rate at a measurement regions of a targe vessel as use of a known technique on a known device to yield a predictable result (in this case, the Leijssen/Feldkamp/Heller combination utilizing Nagarkar’s method to determine blood flow rate).
Further regarding claim 7; Nagarkar further discloses the at least one vascular state includes a hardening level of the target vessel at a measurement region corresponding to the two of the plurality of coils (Nagarkar teaches detecting anomalies such as hypovolemia, internal bleeding, cardiac output, and/or flow restrictions caused by atherosclerosis, wherein atherosclerosis is the hardening of blood vessels; paragraph [0086]). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the control module of the Leijssen/Feldkamp/Heller/Nagarkar combination to detect a hardening level of the target vessel at a measurement region in order to detect and alert a practitioner of possibly physiological issues with a patient’s vasculature.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2014/0077800 A1 to Frauenrath et al; discloses a magnetic field apparatus and method of operating a magnetic field apparatus.
US 2012/0150458 A1 to Sodickson et al; discloses apparatus, method and CPU medium for non-invasive determination of electrical properties of tissues and materials.
US 2009/0203988 A1 to Phua et al; discloses an apparatus and method for non-invasively sensing pulse rate and blood flow anomalies.
US 2021/0251546 A1 to Tai et al; discloses an inductive damping brain sensor.
US 7,923,995 B2 to Schultz et al; discloses a sensor coil array for magnetic inductance tomography with reduced mutual coil coupling.
US 11,806,123 B2 to Hartwell et al; discloses systems and methods for performing magnetic induction tomography.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791