DETAILED ACTION
This Office action is responsive to communications filed on 03/04/2026. Claims 1 & 6 have been amended. Claims 3-4 are canceled. Presently, Claims 1-2, & 5-11 remain pending and are hereinafter examined on the merits.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/04/2026 has been entered.
Response to Arguments
Previous claim objections are withdrawn in view of the amendments filed on 03/04/2026.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on Bezemer et al (US 2018/0143150 A1) in view of Lazarev (US 2021/0271953 A1) rejected under 35 USC § 103 applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new grounds of rejection now relies on Bezemer et al (US 2018/0143150 A1) in view of Muhlsteff et al (US20090306524A1) rejected under 35 USC § 103.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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”, claims 1, 7, 10, and 11 for controlling the signal transceiver invokes 35 U.S.C. 112(f).
“signal generation unit”, claims 1 and 9 for generating an AC signal and provide the AC signal to the signal transducer to generate electromagnetic signals invokes 35 U.S.C. 112(f).
“processing unit”, claims 1, and 11 for calculating a characteristic signal based on the electromagnetic signals invokes 35 U.S.C. 112(f).
“matching element” in claim 6 configured for matching invokes 35 U.S.C. 112(f).
“depth detection unit”, claim 7 for sending a detection signal to the tissue and provide depth information corresponding to the tissue invokes 35 U.S.C. 112(f).
“communication unit”, claim 11 for outputting the characteristic signal invokes 35 U.S.C. 112(f).
“electronic device”, claim 11 for receiving the output of the characteristic signal invokes 35 U.S.C. 112(f).
The terms “unit”, ”device”, ”module” are non-structural generic placeholder that do not include any specific structure for performing the accompany functions. See MPEP 2181.I.A: The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6: "mechanism for," "module for," "device for," "unit for," "component for," "element for," "member for," "apparatus for," "machine for," or "system for." Welker Bearing Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d 1289, 1293-94 (Fed. Cir. 2008); Massachusetts Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1354, 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media, 161 F.3d at 704, 48 USPQ2d at 1886–87; Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 (Fed. Cir. 1998).
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“signal generation unit” refers to a generic AC/DC converter in specification paragraph ¶0024
“processing unit”, refers to a generic processor in specification paragraph ¶0024.
“depth detection unit”, refers to an optical element in specification paragraph ¶0034.
“communication unit”, refers to a Bluetooth or wireless network in specification paragraph ¶0041.
:
the Applicants specification states:
¶0032, ‘In this embodiment, referring to FIG. 5 , the vascular state measuring device 300 may further include the matching element 330. The matching element 330 is arranged on an inner wall 31031 of the tunnel structure 3103 of the signal transceiver 310. Specifically, the gap GA may exist between the to-be-measured part T and the inner wall 31031 of the tunnel structure 3103. The gap GA may cause, for example, the signal transceiver 310 to slip or misalign. In this embodiment, the matching element 330 may be made of an elastic or soft material to fill the gap GA, so as to avoid the measurement inaccuracy caused by the displacement of the signal transceiver 310. In terms of signal transmission, in this embodiment, the matching element 330 may be made of a material which has magnetic impedance in a range between the magnetic impedance of the to-be-measured part T and the magnetic impedance of the signal transceiver 310. Specifically, in this way, the energy loss during the energy transfer between the first electromagnetic signal MS1 and the second electromagnetic signal MS2 is reduced, so as to achieve the purpose of measuring the required signal or improving the signal-to-noise ratio with less energy, thereby avoiding problems such as injury to the subject or insufficient endurance of the device caused by excessive energy. However, the purpose of arranging the matching element 330 is not limited to the above example.’; ¶0033, ‘The matching element 330 may be used as a buffer arranged between the signal transceiver 310 and the to-be-measured part T. For example, the comfort of the subject or the stability during measurement can be improved. In terms of signal transmission, a proper dielectric material may be selected to improve the energy transfer efficiency of the first electromagnetic signal MS1 and the second electromagnetic signal MS2. The power consumption of the vascular state measuring device 300 can be reduced. Efficient energy transfer can also greatly reduce the risk of subjects being exposed to electromagnetic waves.’.
Accordingly, based on the Applicant’s specification the matching element is a dielectric material. Therefore, it can be broadly interpreted that a generic “dielectric material“ has a magnetic impedance between a magnetic impedance of the subject and a magnetic impedance of the signal transceiver in view of the Applicant’s 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 Objections
The following claims are objected to because of the following informalities and should recite:
Claim 5, “The vascular state measuring device according to claim [[4]]1,”.
Claim 4 has been indicated canceled in the amendment filed on 03/04/2026. Appropriate dependency is needed.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5, & 11 are rejected under 35 U.S.C. 103 as being rejected under Bezemer et al (US 2018/0143150 A1) in view of Muhlsteff et al (US20090306524A1).
Claim 1: Bezemer discloses, A vascular state measuring device, comprising: ([Abstract], ‘There is provided an apparatus for using magnetic induction spectroscopy, MIS, to determine a measure of the fluid content of a tissue sample of a subject, the apparatus comprising a first excitation coil that is to be placed near to the tissue sample for inducing a current in the tissue sample; a reference coil; a second excitation coil that is arranged close to the reference coil and that is for inducing a current in the reference coil; and a control unit that is configured to apply an alternating current to the first excitation coil and the second excitation coil; obtain a measure of the current induced in the tissue sample; and determine a measure of the fluid content of the tissue sample from the measure of the current induced in the tissue sample.’; ¶0139, ‘It will be appreciated that low tissue water content results in low tissue conductivity and magnetic inductance and this, in turn, results in a weaker magnetic field 16 generated by the eddy current 14, which is sensed by the receiver coil 8. Similarly, higher tissue water content results in higher tissue conductivity and magnetic inductance and thus a stronger eddy current 14 and stronger magnetic field 16. It will be appreciated that pulsatile beat-to-beat changes in tissue blood volume result in pulsatile beat-to-beat changes in tissue conductivity.’)
a signal transceiver having a tunnel structure for arranging a subject, (¶0164, ‘a solution to the movement problem is to configure the first excitation coil 46 so that it can be placed around the tissue sample 44 to be measured. That is, the excitation coil is placed around the tissue sample 44 so that the tissue sample is in the centre (core) of the coil 46. When applied to the MIS apparatus 42 shown in FIG. 3, the receiver coil 48 is also configured such that it can be placed around the tissue sample 44 to be measured. Thus the coils 46, 48 are configured so that they can be placed around a finger, toe, wrist, ankle, arm, leg, waist, torso of the patient as required for the measurement to be taken… The coils 46, 48 can thus be arranged in an item of clothing or jewellery (e.g. a ring, bracelet or watch) so that they can be easily and consistently used by the patient to measure the fluid content of the tissue sample 44.’; ¶0174, ‘The MIS apparatus 62 comprises an excitation coil 66 that is configured so that it can be placed around a finger, toe, wrist, ankle, arm, leg, waist, torso of the patient as required for the measurement to be taken. The coil 66 can thus be arranged in an item of clothing or jewellery (e.g. a ring, bracelet or watch) so that they can be easily and consistently used by the patient to measure the fluid content of the tissue sample 64.’)
The apparatus of Bezemer comprises an excitation coil 46 and excitation coil 56 and reference coil 58 serve as a first coil and a receiver component (such as the receiver coil 48) which collectively function together as a signal transceiver. These components are configured to be placed around the tissue sample, FIG. 6, ¶0164, ¶0174, (i.e., around a finger arranged in an item of jewelry such as a ring) creating a structure that is tunnel for arranging to the to-be measured part within it. FIG. 6 illustrates such an arrangement where the excitation coil and receive coil placed around the finger, effectively forming a tunnel structure.
wherein the signal transceiver is configured to output at least a first electromagnetic signal to the subject toward the tunnel structure to generate an eddy current at the subject, and receive a second electromagnetic signal generated by the corresponding eddy current; (¶0151, ‘The control unit 50 comprises excitation coil driving circuitry 52 that generates an alternating current having magnitude I and frequency f for driving the excitation coil 46 to generate a magnetic field, and a processing unit 54 that receives the voltage signal induced in the receiver coil 48 by the eddy current in the tissue sample 44 and determines an indication of the tissue fluid content (e.g. the conductivity of the tissue sample 44 or the phase difference Δφ) from the voltage signal and a reference signal from the excitation coil driving circuitry 52 that corresponds to the voltage signal used to drive the excitation coil 46. The frequency of the alternating current from the driving circuitry 52 is typically in the range of 1-10 MHz’)
-The apparatus of Bezemer includes an excitation coil driven by alternating current to generate a magnetic field, which is an electromagnetic signal. This magnetic field is directed to the tissue (the “subject) within or near the tissue. The alternating magnetic field generated by the excitation coil causes an eddy current in the tissue sample. The eddy current in the tissue generates a magnetic field which is the second electromagnetic field received by the receive coil 48.
a control module (control unit 50) coupled with the signal transceiver (¶0149, ‘an excitation coil 46 and a receiver coil 48 that are connected to a control unit 50.’), wherein the control module comprises:
a signal generation unit (excitation coil driving circuitry 52) configured to generate an alternating current (AC) signal and provide the AC signal to the signal transceiver to generate the first electromagnetic signal; and (¶0151, ‘The control unit 50 comprises excitation coil driving circuitry 52 that generates an alternating current having magnitude I and frequency f for driving the excitation coil 46 to generate a magnetic field, and a processing unit 54 that receives the voltage signal induced in the receiver coil 48 by the eddy current in the tissue sample 44 and determines an indication of the tissue fluid content (e.g. the conductivity of the tissue sample 44 or the phase difference Δφ) from the voltage signal and a reference signal from the excitation coil driving circuitry 52 that corresponds to the voltage signal used to drive the excitation coil 46. The frequency of the alternating current from the driving circuitry 52 is typically in the range of 1-10 MHz’)
-The control unit comprises the excitation coil driving circuitry. This circuity functions as a “signal generation unit” by generating alternating current (AC) signal. This AC signal is provided to the excitation coil (part of the signal transceiver function) to generate the first electromagnetic signal (magnetic field).
a processing unit (processing unit) configured to calculate a characteristic signal based on the first electromagnetic signal and the second electromagnetic signal (¶0151, ‘The control unit 50 comprises excitation coil driving circuitry 52 that generates an alternating current having magnitude I and frequency f for driving the excitation coil 46 to generate a magnetic field, and a processing unit 54 that receives the voltage signal induced in the receiver coil 48 by the eddy current in the tissue sample 44 and determines an indication of the tissue fluid content (e.g. the conductivity of the tissue sample 44 or the phase difference Δφ) from the voltage signal and a reference signal from the excitation coil driving circuitry 52 that corresponds to the voltage signal used to drive the excitation coil 46. The frequency of the alternating current from the driving circuitry 52 is typically in the range of 1-10 MHz”), wherein the characteristic signal corresponds to at least one state of at least one blood vessel at the subject; and (¶0139, ‘It will be appreciated that low tissue water content results in low tissue conductivity and magnetic inductance and this, in turn, results in a weaker magnetic field 16 generated by the eddy current 14, which is sensed by the receiver coil 8. Similarly, higher tissue water content results in higher tissue conductivity and magnetic inductance and thus a stronger eddy current 14 and stronger magnetic field 16. It will be appreciated that pulsatile beat-to-beat changes in tissue blood volume result in pulsatile beat-to-beat changes in tissue conductivity.’; [Claim 14], ‘the method further comprising the steps of: determining a plurality of measures of the fluid content of the tissue sample over time; and analysing the plurality of measures of the fluid content of the tissue sample over time to determine a measure of the heart rate, breathing rate and/or pulse pressure variations of the subject.’)
Bezemer discloses: the coils are configured so that they can be placed around a finger of the patient and thus arranged in an item of jewelry (e.g., ring), ¶0164.
wherein the signal transceiver comprises:
a first coil (first and second excitation coil 46/56 and reference coil 58) configured to emit the first electromagnetic signal, wherein a hollow part of the first coil serves as a tunnel part of the tunnel structure; and (-- The apparatus of Bezemer comprises an excitation coil 46 and excitation coil 56 and reference coil 58 serve as a first coil, and a receiver component (such as the receiver coil 48 – second coil, which function together as a signal transceiver. The excitation coils and receive coil are configured to be placed around the tissue sample, FIG. 6, ¶0164, ¶0174, (i.e., around a finger arranged in an item of jewelry such as a ring) creating a structure that is tunnel for arranging to the to-be measured part within it. FIG. 6 illustrates such an arrangement where the excitation coil and receive coil placed around the finger, effectively forming a tunnel structure, ¶0164, ¶0174. -The apparatus of Bezemer includes the excitation coils driven by alternating current to generate a magnetic field, which is the first electromagnetic signal, ¶0151. Accordingly, the hollow part of excitation 46 which correspond to the excitation coil 46 and reference coil 58, serves as a part of the tunnel structure, as required by the claim.)
a second coil (receive coil 48);
wherein a spacing is defined between the first position and the second position;
-The apparatus of Bezemer comprises an excitation coil 46 and excitation coil 56 and reference coil 58 serve as a first coil, and a receiver component (such as the receiver coil 48 – second coil, which function together as a signal transceiver. The excitation coils and receive coil are configured to be placed around the tissue sample, FIG. 6, ¶0164, ¶0174, (i.e., around a finger arranged in an item of jewelry such as a ring) creating a structure that is tunnel for arranging to the to-be measured part within it. FIG. 6 illustrates such an arrangement where the excitation coil and receive coil placed around the finger, effectively forming a tunnel structure, ¶0164, ¶0174. -The apparatus of Bezemer includes the excitation coils driven by alternating current to generate a magnetic field, which is the first electromagnetic signal, ¶0151. Accordingly, the hollow part of excitation 46 which correspond to the excitation coil 46 and reference coil 58, serves as a part of the tunnel structure, as required by the claim. (and thus the first coil is arranged at a first position in the tunnel structure, the second coil is arranged at a second position in the tunnel structure, and a hollow part of the second coil serves as a part of the tunnel structure; wherein a spacing is defined between the first position and the second position. The spacing is defined by their position.
wherein the first coil is arranged at a first position in the tunnel structure, the second coil is arranged at a second position in the tunnel structure, and a hollow part of the second coil serves as a tunnel part of the tunnel structure; (¶0150, ‘The diameters of the excitation coil 46 and receiver coil 48 and the number of windings depend on the size/area of the tissue sample to be investigated. The number of windings should be as high as possible given the chosen geometry. However, if the excitation coil 46 and receiver coil 48 are provided on a printed circuit board (PCB), the number of windings can be as low as 1 or 2. However, the strength of the excitation field is linearly proportional to the number of windings and the current, so more windings could be beneficial. An exemplary diameter for the excitation coil 46 and receiver coil 48 is 5 cm, although other diameters can be used.’)
Bezemer fails to disclose: that the second coil is configured to emit the second electromagnetic signal;
wherein a spacing is defined between the first position and the second position;
wherein a time difference exists between receiving of the second electromagnetic signal by the first coil and receiving of the second electromagnetic signal by the second coil; and
wherein the processing unit is configured to calculate the at least one state based on a pulse transit time derived by the spacing and the time difference.
However, Muhlsteff in the context of measuring pulse transmit time (PTT) from two points at a distance in concert with electromagnetic coils discloses:
a second coil configured to emit the second electromagnetic signal;
-Muhlsteff describes non-invasive sensors that use electrical coils to generate a magnetic filed, which creates an inductive coupling with the tissue and blood in the subject’s body, ¶Abstract, ¶0022, ¶0048.
wherein a spacing is defined between the first position and the second position;
-The measuring system of Muhlsteff teaches using two sensors attached to the body where the sensing positions are “spaced apart”, Claim 5 & 8. Muhlsteff specifically, measures pulse passing at “two points at a distance d”, ¶0007, “.
wherein a time difference exists (¶0007, “pulse transit time (PTT) [...] by measuring the time-difference of a pulse passing two points at a distance d’) between receiving of the second electromagnetic signal by the first coil and receiving of the second electromagnetic signal by the second coil; and
-Muhlsteff describes the first coil detects a signal change when the physical blood pulse passes it, and the second coil detects a separate signal change when the blood pulse later passes it, the time delay between those events is indeed measuring the pulse propagation time (i.e., the PPT/PTT). Specifcally, Muhlsteff determines this by detecting the passing of the pulse wave at two spaced apparat sensing locations and measuring the time difference between them, ¶0007, Claim 5, Claim 7. The coils at each location create a localized inductive coupling, ¶0018. When the blood wave passes the first coil, the local conductivity and blood vessel geometry changes altering the magnetic coupling and creating a detectable signal, ¶0022. The blood wave then continues traveling down the artery to the second coil where it alters the coil’s local magnetic coupling to create a second detectable signal, ¶0022. Therefore, by measuring the time delay between the first coil’s localized electromagnetic signal even, and the second coils localized electromagnetic signal event, the Muhlsteff teaches effectively timing how long it took the blood pulse to travel the physical distance between the two locations, (i.e., the PTT).
wherein the processing unit is configured to calculate the at least one state based on a pulse transit time derived by the spacing and the time difference.
-Muhlsteff confirms that the processing unit determines the pulse transit time (PTT) based on the detected pulse waves passing the two sensors derived by the spacing and time difference. The processing unit uses this PTT to calculate a physiological state, specifically the subject’s blood pressure (BP), ¶0007, Claim 8, ¶0080-0081.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the second coil of Bezemer to be a second coil configured to emit the second electromagnetic signal as taught by Muhlsteff. The motivation to do this yield predictable results such as provide an easy-to-use technique for measuring BP and/or other vital signs of a subject for unsupervised, long-term continuous monitoring of BP and other vital signs, like heart rate and respiration rate, as suggested by Muhlsteff, ¶Abstract, ¶0017, ¶0026
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processing circuitry of modified Bezemer such that wherein the processing unit is configured to calculate the at least one state based on a pulse transit time derived by the spacing and the time difference, wherein a spacing is defined between the first position and the second position and wherein a time difference exists between receiving of the second electromagnetic signal by the first coil and receiving of the second electromagnetic signal by the second coil as taught by Muhlsteff. The motivation to do this yield predictable results such as provide an easy-to-use technique for measuring BP and/or other vital signs of a subject for unsupervised, long-term continuous monitoring of BP and other vital signs, like heart rate and respiration rate, as suggested by Muhlsteff, ¶Abstract, ¶0017, ¶0026
Claim 2: Modified Bezemer discloses all the elements above in claim 1, Bezemer discloses, wherein the subject is a finger. (¶0164, ‘ […] Thus the coils 46, 48 are configured so that they can be placed around a finger [...]‘; ¶0174, ‘The MIS apparatus 62 comprises an excitation coil 66 that is configured so that it can be placed around a finger’)
Claim 5: Modified Bezemer discloses all the elements above in claim 4, Bezemer discloses, wherein the at least one state comprises blood pressure of the at least one blood vessel at the subject. (¶0215, ‘Detecting this ventilation-induced pulse pressure modulation in the MIS measurements allows for the respiration rate to be assessed. These pulse pressure variations (PPV), moreover, are considered a measure of a patient's volume status; high PPV have been associated with hypovolemia and fluid responsiveness. The measurement of heart rate, ventilation rate, and PPV is possible with all of the embodiments and aspects described herein.’; ¶0218, ‘Early warning for hypovolemia—Hypovolemia is common in various very large patient populations in the ward, intensive care unit (ICU), and operating room (OR) due to: insufficient oral/intravenous fluid intake, vasorelaxing anaesthesia, internal bleeding, sepsis, kidney dysfunction, and increased fluid losses due to mechanical ventilation, fever, vomiting, and diarrhoea. Mild states of hypovolemia before surgery have been associated with worse outcomes. A hypovolemia-check could reveal occult internal bleeding in patients in the ambulance and in the emergency room (ER). Since the first compensation mechanism for correction of hypovolemia is shifting fluids from the tissue to the blood, tissue (de)hydration and patient volume status are physiologically related. A MIS apparatus measuring (a loss of) tissue water would therefore provide an early warning for hypovolemia in hospitalised patients in the ward, ICU, OR, and ER.’)
-Hypovolemia indicates a risk of low blood pressure hence the at least one state comprises blood pressure of the at least one blood vessel at the subject, as required by the claim.
Claim 11: Modified Bezemer discloses all the elements above in claim 1, Bezemer discloses, wherein the control module (control unit 50) further comprises: a communication unit coupled with the processing unit, wherein the communication unit is configured to output the characteristic signal to an electronic device. (¶0217, ‘The MIS apparatus described above can provide feedback on a patient's hydration status, vital signs such as heart rate, and provide a warning of under- or over-hydration to either the patient themselves (e.g. through some direct indicator that is part of the apparatus) or to medical personnel (e.g. through communicating wirelessly, such as with Wi-Fi, Bluetooth or a cellular telecommunication technology to a remote location). Since MIS in principle does not require tissue contact, it is possible to implement the apparatus in a number of different forms. For example the MIS apparatus could be formed as an anklet, bracelet, watch, ring, textile, or a hand-held device.’)
Claim 6 is rejected under 35 U.S.C. 103 as being rejected under Bezemer et al (US 2018/0143150 A1) in view of Muhlsteff et al (US20090306524A1), as applied to claim 1, in further view of Lazarev (US 2021/0271953 A1).
Claim 6: Modified Bezemer discloses all the elements above in claim 1, Bezemer discloses: the coils are configured so that they can be placed around a finger of the patient and thus arranged in an item of jewelry (e.g., ring), ¶0164.
Bezemer fails to disclose: further comprising, a matching element arranged on an inner wall of the tunnel structure, wherein a magnetic impedance of the matching element is between a magnetic impedance of the subject and a magnetic impedance of the signal transceiver.
In view of the 35 U.S.C. 112(f) interpretation, the Applicants specification states:
¶0032, ‘In this embodiment, referring to FIG. 5 , the vascular state measuring device 300 may further include the matching element 330. The matching element 330 is arranged on an inner wall 31031 of the tunnel structure 3103 of the signal transceiver 310. Specifically, the gap GA may exist between the to-be-measured part T and the inner wall 31031 of the tunnel structure 3103. The gap GA may cause, for example, the signal transceiver 310 to slip or misalign. In this embodiment, the matching element 330 may be made of an elastic or soft material to fill the gap GA, so as to avoid the measurement inaccuracy caused by the displacement of the signal transceiver 310. In terms of signal transmission, in this embodiment, the matching element 330 may be made of a material which has magnetic impedance in a range between the magnetic impedance of the to-be-measured part T and the magnetic impedance of the signal transceiver 310. Specifically, in this way, the energy loss during the energy transfer between the first electromagnetic signal MS1 and the second electromagnetic signal MS2 is reduced, so as to achieve the purpose of measuring the required signal or improving the signal-to-noise ratio with less energy, thereby avoiding problems such as injury to the subject or insufficient endurance of the device caused by excessive energy. However, the purpose of arranging the matching element 330 is not limited to the above example.’; ¶0033, ‘The matching element 330 may be used as a buffer arranged between the signal transceiver 310 and the to-be-measured part T. For example, the comfort of the subject or the stability during measurement can be improved. In terms of signal transmission, a proper dielectric material may be selected to improve the energy transfer efficiency of the first electromagnetic signal MS1 and the second electromagnetic signal MS2. The power consumption of the vascular state measuring device 300 can be reduced. Efficient energy transfer can also greatly reduce the risk of subjects being exposed to electromagnetic waves.’.
Accordingly, based on the Applicant’s specification the matching element is a dielectric material. Therefore, it can be broadly interpreted that a generic “dielectric material“ has a magnetic impedance between a magnetic impedance of the subject and a magnetic impedance of the signal transceiver in view of the Applicant’s specification.
Accordingly, Lazarev is relied upon above discloses: a dielectric material (i.e., matching element) arranged on an inner wall of a tunnel structure (¶0024, ‘the diameter of jewelry warn on the finger or the diameter of a bracelet worn on the wrist.’; ¶0025, ‘The coils of conductive material of the frame antenna 5 may be arranged within the dielectric substrate 7 or on its outer surface with the protective enclosure of the coils.’; ¶0026, ‘The coils of conductive material of the frame antenna 5, the microchip 4, and the capacitor 6, which are arranged within the annular groove 3 on the dielectric substrate 7, may be hermetically sealed by a layer of protective material, thus improving the operational reliability of the device’)
According to MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product.”
Therefore, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the inner wall of tunnel structure of modified Bezemer such that it includes a dielectric material as taught by Lazarev for the advantage of improving the operational reliability of the device, ¶0026 of Lazarev. The modified combination would disclose: further comprising: the matching element arranged on an inner wall of the tunnel structure as recite in claim 1, wherein a magnetic impedance of the matching element is between a magnetic impedance of the subject and a magnetic impedance of the signal transceiver as recited in claim 6.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bezemer et al (US 2018/0143150 A1) in view of Muhlsteff et al (US20090306524A1), as applied to claim 1, in further view of Urano (US 2006/0184050 A1).
Claim 7: Modified Bezemer discloses all the elements above in claim 1, Bezemer discloses: send a detection signal to the subject to provide depth information corresponding to the at least one blood vessel to the control module, wherein the control module adjusts a frequency or a strength of the first electromagnetic signal based on the depth information.
-Bezemer discloses the measurement depth of MIS depends on the strength of the excitation field. This strength is determined by the magnitude of the alternating current applied to the excitation signal. To measure fluid content at a particular depth, the strength of the excitation field can be set to a specific value. Multiple MIS measurements can bet taken using different excitation fields to obtain fluid content measurements at various depths within the tissue sample. These measurements can bet combined to yield differential depth measurements which are more robust against single depth MIS measurements, ¶0151, ¶0212-0213 & Claim 5. Therefore, Bezemer sending a detection signal to the subject to provide depth information corresponding to the at least one blood vessel to the control module, wherein the control module adjusts a frequency or a strength of the first electromagnetic signal based on the depth information.
Bezemer fails to disclose: further comprising: a depth detection unit
However, Urano discloses: further comprising: a depth detection unit.
-Urano discloses a light irradiating unit, 102, and at least to detecting elements, 104, ¶0032, wherein the optical device (1) is configured to acquire the depth information of the target object, ¶Abstract, ¶0016, & ¶0017. This is achieved by comparing the intensity of light detected by the detecting elements when the target object is present with a calculated data when the target object is not present. ¶0016-0017, ¶0047-0048, ¶0059, ¶0062. The “absorber depth analyzer: within the control/analysis unit calculates the subcutaneous depth of the target object based on these comparisons and the distance between the detecting element and the light irradiating unit, ¶0046-0047, & ¶0062. Urano explicitly states that the “target object” can be blood (hemoglobin), ¶0066.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Bezemer to include a depth detection unit in view of the teachings of Urano for the advantage of improving resolution in the depth direction, allow for the determination of the “depth of occurrence of change” rather than just distinguishing between shallow and deep parts, ¶0074 of Urano.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bezemer et al (US 2018/0143150 A1) in view of Muhlsteff et al (US20090306524A1), as applied to claim 1, in further view of Costa et al (US 2020/0297286 A1).
Claim 8: Modified Bezemer discloses all the elements above in claim 1, Bezemer discloses, wherein the signal transceiver (-The apparatus of Bezemer comprises an excitation coil 46 and excitation coil 56 and reference coil 58 serve as a first coil and a receiver component (such as the receiver coil 48) which collectively function together as a signal transceiver. These components are configured to be placed around the tissue sample, FIG. 6, ¶0164, ¶0174, (i.e., around a finger arranged in an item of jewelry such as a ring) creating a structure that is tunnel for arranging to the to-be measured part within it.) further outputs leading electromagnetic signals (-Bezemer indicates a phase delay in the received electromagnetic signal due to the presence of the tissue sample, wherein the control unit (50) applies the same alternating current to both the first and second excitation coils, ¶0152 & ¶0157. When no tissue sample is present near the receive coil (48), the signal (current) inducted in the receiver coil by the first excitation coil (46) and the signal (current) induced in the reference coil (58) by the second excitation coil (56) will be exactly 180 degrees out of phase with each other (i.e., cancel each other out at each point in time), ¶0152 & ¶0209-0211. When a tissue sample (44) is near the receiver coil (48), the alternating magnetic field from the first excitation coil (46) to induce an eddy current (14) within the tissue sample, ¶0138-0139, ¶0157. The eddy current itself generates a secondary magnetic field (16), ¶0138-0139. The signal induced in the receiver coil (48) Is not a combination of the direct signal from the first excitation coil and the signal from the tissue’s eddy current, ¶0157. The presence of the tissue introduces a phase delay in the signal within the receiver coil, ¶0209-0211.). That is this controlled suppression of the direct influence is considered the “leading electromagnetic signal” generated.)
Bezemer fails to disclose: outputs leading electromagnetic signals before outputting the first electromagnetic signal, wherein each of the leading electromagnetic signals corresponds to a leading signal parameter, and a signal parameter of the first electromagnetic signal corresponds to one of the leading signal parameters with an optimal response.
However, Costa in the context of characterization diagnosis of blood pressure using electromagnetic signals discloses, outputs leading electromagnetic signals before outputting the first electromagnetic signal, wherein each of the leading electromagnetic signals corresponds to a leading signal parameter, and a signal parameter of the first electromagnetic signal corresponds to one of the leading signal parameters with an optimal response.
In view of the 35 U.S.C. 112(b), at least one leading electromagnetic signal constitutes a plurality of electromagnetic signals.
Accordingly, Costa discloses: ¶0012 – Outputtin a plurality of electromagnetic signals before outputting the first electromagnetic signal, Costa describes that the processing system determines these signals by exposing patients to a modulated frequency exposure period involving a series of amplitude modulated electromagnetic frequencies, each emitted sequentially. This collection of distinct signals serves as the leading electromagnetic signals in the diagnostic phase. The plurality of electromagnetic frequency signals are described as amplitude modulated electromagnetic field frequencies which are varying signal parameters, ¶0012-0013.
In turn, the electromagnetic frequency signals are modulated by an amplitude of the carrier signal to produce a desired frequency (and thus, the signal parameter of the first electromagnetic signal corresponds to one of the at least one leading electromagnetic signals with an optimal response).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the signal generation unit of modified Bezemer such that it outputs leading electromagnetic signals before outputting the first electromagnetic signal, wherein each of the leading electromagnetic signals corresponds to a leading signal parameter, and a signal parameter of the first electromagnetic signal corresponds to one of the leading signal parameters with an optimal response as taught by Costa for the advantage of diagnosing a specific health condition of the patient by identifying patterns in physiological responses to various electromagnetic signals, ¶0012 of Costa.
Claim 9: Modified Bezemer discloses all the elements above in claim 8, Bezemer discloses,
wherein the signal generation unit outputs leading AC signals to generate the leading electromagnetic signal (¶0151, ‘The control unit 50 comprises excitation coil driving circuitry 52 that generates an alternating current having magnitude I and frequency f for driving the excitation coil 46 to generate a magnetic field, and a processing unit 54 that receives the voltage signal induced in the receiver coil 48 by the eddy current in the tissue sample 44 and determines an indication of the tissue fluid content (e.g. the conductivity of the tissue sample 44 or the phase difference Δφ) from the voltage signal and a reference signal from the excitation coil driving circuitry 52 that corresponds to the voltage signal used to drive the excitation coil 46. The frequency of the alternating current from the driving circuitry 52 is typically in the range of 1-10 MHz’)
-The control unit comprises the excitation coil driving circuitry. This circuity functions as a “signal generation unit” by generating alternating current (AC) signal. This AC signal is provided to the excitation coil (part of the signal transceiver function) to generate the magnetic field.
Bezemer fails to disclose generating a plurality of leading electromagnetic signals,
However, Costa is relied upon above discloses generating a plurality of leading electromagnetic signals, ¶0012.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the signal generation unit of modified Bezemer which generates an electromagnetic signal by generating an AC signal such that it generates a plurality of leading electromagnetic signals in view of the teachings of Costa for the advantage of diagnosing a specific health condition of the patient by identifying patterns in physiological responses to various electromagnetic signals, ¶0012 of Costa. The modified combination above would disclose, and each of the leading electromagnetic signals corresponds to one of the leading AC signal.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bezemer et al (US 2018/0143150 A1) in view of Muhlsteff et al (US20090306524A1) in view of Costa et al (US 2020/0297286 A1), as applied to claim 8, in further view of Peeters et al (US 2022/0071502 A1).
Claim 10: Modified Bezemer discloses all the elements above in claim 8, Bezemer discloses, a phase adjustment to compensate for a phase delay, ¶0208 and the control module (control unit 50) and the signal transceiver (The apparatus of Bezemer comprises an excitation coil 46 and excitation coil 56 and reference coil 58 serve as a first coil and a receiver component (such as the receiver coil 48) which collectively function together as a signal transceiver. These components are configured to be placed around the tissue sample, FIG. 6, ¶0164, ¶0174, (i.e., around a finger arranged in an item of jewelry such as a ring) creating a structure that is tunnel for arranging to the to-be measured part within it.)
Bezemer fails to disclose, comprises an adjustable passive element coupled with the signal transceiver, and the control module adjusts the adjustable passive element to adjust the leading signal parameters of each of the leading electromagnetic signals.
However, Peeters in the context of inductive sensing to provide contactless measurements of blood vessels dicloses: an adjustable passive element coupled with the signal transceiver, and the control module adjusts the adjustable passive element to adjust the leading signal parameters of each of the leading electromagnetic signals.
-Peeters discloses a resonator circuit that includes a loop antenna (a type of coil) and an electrically coupled capacitor, ¶Abstract & ¶0216; wherein the total capacitance of the resonator may be tuned, and thereby the frequency at which the excitation signals are generated are also tuned, ¶0353. The radial frequency can be cycled in a time-multiplexed manner to obtain more independent measurement signals, ¶0089 where w is the radial frequency of the electromagnetic signals (the time-varying field applied to the body), ¶0150. The system of Peeters can adjust the frequency of the applied excitation signals to improve signal separation, such that different physiological sources in the body are probed at multiple frequencies in a short space time, thereby providing a greater volume of information, ¶0354. Therefore, Peeters, discloses an adjustable passive element coupled to the signal transducer and a control module (microprocessor 56, ¶0227) to adjust the adjustable passive element to adjust a signal parameter of each of the at least one leading electromagnetic signal.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the signal transceiver of modified Bezemer to include an adjustable passive element coupled with the signal transceiver, and the control module adjusts the adjustable passive element to adjust the leading signal parameters of each of the leading electromagnetic signals as taught by Peeters for the advantage of provided an improved apparatus being able to improve signal separation such that different physiological sources in the body are probed at multiple frequencies in a short space time, thereby providing a greater volume of information, ¶0354 of Peeters.
Conclusion
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798