DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/23/26 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-8, 12-16, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Semler (US 20050101875 A1) in view of Sramek (US 5503157 A).
For claim 2, Semler teaches A system for performing impedance measurements on a subject, the system comprising:
a plurality of electrodes [86a-h] configured to be placed in contact with the skin of the subject; [Fig. 8B]
a signal generator [104] coupled to at least a first subset [Fig. 9] of the plurality of electrodes;
a sensor [106a-h] coupled to at least a second subset of the plurality of electrodes; [where electrodes 86a-h can be conditionally set as current and voltage sets (i.e., subsets) via their function at a given measurement step per at least ¶¶103-107];
a first processing system [114] configured to perform impedance measurements on the subject
and, a second processing system [called receiving station (RS) for a remote computing site detailed throughout disclosure of Semler — see first ¶89, ¶100] [More generally for the above limitations pertaining to the use of two processors, throughout ¶¶95-142, Semler details a variety of embodiments where combinations of signal acquisition, processing, and parameter computation occur via a variety of collaborative processors/computers — most often the controller and RS per above — but also embodiments regarding computer networks, subroutines/subdivided computers (both “processors” in one device), and various command/communication schemes — see esp. beginning of ¶96, final sentence of ¶100, middle of ¶105, all of ¶123, end of ¶132, all of ¶133, end of ¶135]
analyse impedance measurements by: using the information to determine impedance values measured at different frequencies [¶103, ¶110, ¶128, and ¶137]
wherein the system is configured to monitor at least one of: changes in fluid levels and diagnosis of the presence, absence or degree of at least one of oedema, pulmonary oedema, lymphoedema, body composition or cardiac function. [throughout ¶¶100-140]
For claim(s) 2 and 19, Semler fails to teach synchronous sampling of the applied signals and measured signals at frequencies across the frequency range including a common clock. However, consider that Semler clearly teaches the use of a range of measuring frequencies in at least ¶103.
Sramek teaches an impedance measurement system [abstract] which performs impedance measurements by synchronously sampling applied signals and measured signals [col. 2 l. 60 – col. 3 l. 25] including a common clock. [col. 7 l. 20 – col. 8 l. 5]
It would have been obvious to one of ordinary skill at the time the invention was made to modify the system of Semler to incorporate the synchronous sampling of Sramek in order to improve tissue safety and improve SNR. As motivated by Sramek cols. 1-3.
For claim 3, Semler teaches The system of claim 2, wherein the second processing system comprises a smart phone. [see most esp. PDA system ¶127; more generally the handheld computer discussed in at least ¶100 well and reasonably (under BRI) constitutes a “smart phone”].
For claim 4, the motivated combination of Semler and Sramek teaches The system of claim 2, wherein the first processing system is configured to perform at least preliminary processing of the synchronously sampled applied and measured signals, [e.g., in Semler via use of sensing amplifiers 106a-h and either/both of
ADC 110 / DAC 108 per ¶100, ¶105 — ¶105 detailing verbatim processing of sensed voltage signals],
and wherein the information is derived from the synchronously sampled applied and measured signals by performing the preliminary processing. [in Semler, receiving instructions for operation from RS per ¶121, middle of ¶122, all of ¶124].
For claim 5, Semler teaches The system of claim 2, wherein the first processing system comprises:
a processor; [114]
a memory; [112]
and an input/output device. [120]
For claim 6, Semler teaches The system of claim 2, wherein the first processing system includes programmable hardware, the operation of which is controlled using instructions, and wherein the instructions are stored within inbuilt memory on the first processing system or downloaded from the second processing system. [execution of onboard instructions or received instructions from (inter alia) RS throughout ¶¶119-125 and ¶141];
For claim 7, Semler teaches The system of claim 2, wherein the first processing system comprises an FPGA. [¶105 where processing elements of Fig. 9 constitute(s), under BRI, a form of an FPGA]
For claim 8, Semler teaches The system of claim 2, wherein the signal generator includes a current circuit and the sensor includes a voltage circuit, and wherein the system further comprises:
a current ADC [Semler conditional use of ADC 110 per ¶100, ¶105 or select channels (i.e., channels as detailed in ¶101) for current injection purposes] configured to:
receive signals from the current circuit; and, provide the indication of the one or more signals applied to the subject to the first processing system; [Semler injected current data acquired by controller 114 from (inter alia) ADC 110 representing current injected through skin (i.e., a form of an indication of signal applied to subject) per ¶107];
a voltage ADC [Semler conditional use of ADC 110 per ¶100, ¶105 or select channels (i.e., channels as detailed in ¶101) for voltage signal acquisition purposes e.g., per ¶105] configured to:
receive signals from a voltage circuit; and, provide the indication of the one or more signals measured from the subject to the first processing system; [Semler - acquisition of voltage signal and processing thereof (i.e., thereby including a form of providing an indication to the first processing system) via ADC(s) 110 per ¶105 and ¶110];
and a control signal DAC [108] configured to:
receive the control signals from the first processing system; [via microprocessor and/or controller 114 per at least ¶100];
and, provide analogue control signals to a current circuit to thereby cause one or more current signals to be applied to the subject in accordance with the control signals. [current injected via defined amplitudes and frequencies via (inter alia) DAC 108 per ¶105, see also ¶107].
For claim 12, Semler teaches The system of claim 2, wherein the system is configured to:
receive configuration data, the configuration data being indicative of at least one feature; determine, using the configuration data, instructions representing the at least one feature; and, cause, using the instructions, at least one of: at least one impedance measurement to be performed; or at least one impedance measurement to be analysed. [¶¶104-120 detailing receiving processing instructions and then performing the measurements and calculations (i.e., ‘configuration data’)]
For claim 13, Semler teaches The system of claim 12, wherein the second processing system receives configuration data and uses the configuration data to update instructions used by the first processing system. [¶¶104-120]
For claim 14, Semler teaches The system of claim 2, wherein the second processing system includes a store for storing a plurality of impedance measurement profiles [most suitably, see storage means for RS per ¶¶113-114, ¶116, all of ¶125, ¶132, ¶¶135-137 where per ¶122, ¶124, device operates from instructions (including measurement procedure instructions thereby) stored in RS];
and wherein the second processing system analyses the impedance measurements in accordance with a selected one of the impedance measurement profiles. [input commands and settings from user per end of ¶105, see end of ¶119 also].
For claim 15, Semler teaches The system of claim 2, wherein the second processing system:
analyses impedance values determined by the first processing system; and determines one or more biological parameters using the analysis. [throughout ¶¶100-140]
For claim 16, Semler teaches The system of claim 2, wherein the second processing system:
determines an impedance measurement procedure; and, at least one of: analyses impedance measurements in accordance with the impedance measurement procedure; or causes the first processing system to perform impedance measurements in accordance with the impedance measurement procedure. [throughout ¶¶100-140]
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Semler in view of Sramek and Lackey (US 20050070778 A1).
For claim 9, Semler teaches The system of claim 8, further comprising:
at least one buffer circuit [circuit including 106a-h (controlled through 114) and 110 and relevant routines of controller 114] configured to:
receive voltage signals from a voltage electrode; [via 86a-h per ¶103, ¶105];
filter and amplify the voltage signals; [multi-frequency current injection per end of ¶104 is a form of filtering via the buffer circuit (i.e., through signal controls of controller per ¶105), amplification via amplifiers 106a-h];
and, transfer the filtered and amplified voltage signals to the voltage ADC; [i.e., per Fig. 9 sensing amplifiers 106a-h connect to ADC including for voltage processing as per ¶105];
at least one current source circuit [104] configured to:
receive one or more control signals; [from controller per ¶100 and ¶105];
filter and amplify the control signals to thereby generate one or more current signals; [multi-frequency current injection per end of ¶104 is a form of filtering via the buffer circuit (i.e., through signal controls of controller per ¶105), amplification via amplifiers 106a-h];
apply the current signals to a current electrode; [¶103]
and transfer an indication of the applied signals to the current ADC. [through controller/processor 114 per ¶107].
Semler fails to teach the buffer circuit transferring the voltage signals to the voltage ADC via (specifically) a differential amplifier.
Lackey teaches a bioimpedance system [entire disclosure – see at least abstract, ¶26] comprising a circuit which transfers voltage signals to an ADC [225] via a differential amplifier [115/220] [see esp. ¶39 detaiing ADC acquiring voltage from amplifier 220; consider also ¶28].
It would have been obvious to one of ordinary skill at the time the invention was made to modify the voltage signal transfer to the voltage ADC of Semler to incorporate the differential amplifier for transfer as taught by Lackey in order to amplify (i.e., strengthen) a voltage signal obtained from a subject. As motivated by Lackey ¶For claim 39, Semler teaches
For claim 10, Semler teaches The system of claim 9, wherein the first processing system is configured to:
receive signals from the current and voltage ADCs; [i.e., subchannels and conditional usage of ADCs 110 (channels per ¶101 and plural ADCs per ¶105) for each voltage (¶105) and current (¶107)];
and perform preliminary processing of the signals. [see verbatim processing per ¶105, optional processing at monitor per end of ¶107] [more generally throughout ¶¶80-140 the processing of the impedance and other sensed signals is discussed which would include first steps constituting “preliminary processing” — see, numerous processing / calculative steps in ¶¶114-116 et seq.].
For claim 11, Semler teaches The system of claim 10, wherein the preliminary processing includes at least one of:
extracting ECG signals; [¶25][more generally ECG monitoring / ‘extracting’ is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Semler]
and filtering the signals.
In consideration of Examiner’s interpretation and citation for the FPGA in claim(s) 7, and in earnest and good faith advancement of prosecution, claim(s) 7 is/are alternately rejected under 35 U.S.C. 103 as being unpatentable over Semler in view of Sramek and Tyson (US 20050069853 A1).
If (arguendo) Semler fails to teach an FPGA, then:
Tyson teaches an impedance system [¶78] comprising an FPGA [¶38].
It would have been obvious to one of ordinary skill at the time the invention was made to modify the processors of the system of Semler to incorporate the FPGA of Tyson as such a processor type would be well-known in the art to aid in software and analysis implementation. As motivated by Tyson ¶38.
Response to Arguments
Applicant's 11/24/25 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 7 that the combination of Semler and Sramek would not be obvious. Applicant appears to reiterate the reasoning set forth in the 9/3/25 remarks. Namely, the references do not seek the same problem and modifying Semler in view of Sramek would increase the processing requirements of Semler and thus the combination would not be obvious. Examiner respectfully disagrees and reiterates his position set forth previously. The (relative) simplicity of one reference compared to another is not itself evidence of nonobviousness as per MPEP § 2143.01. Both Semler and Sramek deal with current / voltage / signal controls to propagate through tissues for medical purposes. The combination of teachings is both reasonable and in an analogous field of art.
Applicant then argues in remarks p. 8 that Semler and Sramek together or alone fail to teach determining an oedema. Examiner respectfully disagrees. Semler details throughout ¶¶100-140 esp. ¶110, ¶128, and ¶137 that fluid accumulations are determined and thus the proposed amendment is still taught.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
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