DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Invention I, claims 1-5 and 11-15, in the reply filed on 2/26/2026 is acknowledged. The traversal is on the ground(s) that there would be no serious burden on the examiner to examiner both Invention I and II, specifically noting that invention II includes all of the limitations of invention I. This is not found persuasive because although the method of invention II recites similar limitations to that of Invention I, invention I further requires the specific use of particular hardware (i.e. signal generator, receiver, demodulation circuit, processor) while the method could be completed by numerous different elements of carrying out the same functions. As such, the inventions have acquired a separate status in the art in view of their different classification; the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and the inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries). Further, prior art applicable to one invention may not be applicable to the other invention (i.e. prior art showing the method could employ hardware the same as the system claims); and/or the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a).
The requirement is still deemed proper and is therefore made FINAL.
The examiner further notes that the applicant’s response on 2/26/2026, only elected invention I and did not include an election of previously identified species A, B, or C (see section 4 on page 3 of restriction requirement mailed 1/29/2026). In order to advance prosecution, the examiner called applicant to see if an election of species could be completed over the phone (see attached interview summary and email response from attorney Roger Chen). In response, the applicant elected Species A for further examination. Examiner notes that the 2/26/2026 response identifies claims 1-5 as being directed to species A, and claims 11-15 as directed to species C. Upon review of the claims, it appears that the applicant’s identified claims do not align with the species as described in the restriction requirement.
Specifically, the restriction describes Species A as depicted in figures 3 and 6, described in paragraphs [0023]-[0025]; species B as depicted in figure 7 and described in paragraphs [0026]-[0028]; and species C as depicted in figure 9 and described in paragraph [0029]. Upon further consideration of the claims and species during examination, the examiner has determined that Species A and B are not mutually exclusive, and accordingly the restriction between previously indicated species A and B is withdrawn. However, examiner notes that species C is still mutually exclusive from combined Species A and B. A review of the claims shows that claims 1-4 and 11-14 are drawn to Species A and B which were elected by the applicant in the response received 3/25/2026. However, the examiner notes that claims 5 and 15 appear to be drawn to Species C, as they include limitations drawn to the reference impedance value connecting in series between the over-sampling pattern current generator and the bioimpedance as depicted in figure 9 and described in paragraph [0029]. Accordingly, claims 5 and 15 are withdrawn as being directed to species C.
In conclusion, applicant has elected Invention I, species A and B (as examiner withdrew the restriction between species A and B), directed to claims 1-4 and 11-14, for prosecution.
Claim Objections
Claims 2 is objected to because of the following informalities: The recitation of the limitation “wherein the probing signal is a current signal” is redundant and not further limiting in view of the applicant’s preliminary amendment to recite in “wherein the probing signal comprises an oversampled current waveform including a plurality of sub-period current levels within one period of the first frequency”. Since claim 1 already identifies the probing signal as a current waveform/signal, it doesn’t appear necessary to further recite that the probing signal is a current signal. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: “bioimpedance measurement device” in claims 11-14. The bioimpedance measurement device uses the nonce term “device” and is described functionally without sufficient structure to take it out of a 35 USC 112(f) invocation.
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 application, “the bioimpedance measurement device…configured to input a probing signal having a first frequency and an over-sampling pattern into the bio-impedance, receive a first response signal related to the probing signal from the bio-impedance, generate a first in-phase signal and a first quadrature-phase signal according to the first response signal, and analyze the probing signal, the first in-phase signal and the first quadrature-phase signal to determine a bio-impedance value of the bio-impedance” is described in the specification in paragraph [0023] as: an oversampling pattern current generator configured to generate a probing signal; a receiver configured to receive a response; a demodulation circuit coupled to the receiver configured to demodulate the response signal to an in phase signal and a quadrature phase signal; and a processor coupled to the demodulation circuit configured to analyze the probing signal, the in-phase signal and the quadrature phase signal to determine the bioimpedance; or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 11-14 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In the instant case, claims 11-14 positively recites “a bio-impedance” which in view of the specification is clearly described a bioimpedance of a human organism, and thus positively recites the human organism.
The examiner encourages the applicant to amend the claim so as to not positively claimed the bioimpedance within the claim, but rather to claim how the bioimpedance measurement system is configured to measure a bioimpedance or configured to contact a bioimpedance, or similar to avoid the 101 issues.
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 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Barrettino et al (US 2018/0284170 A1) in view of Wasserman (EP 4 074 370 A1).
Regarding claims 1-3; Barrettino discloses a bio-impedance measurement device (figures 2 and 3b, 7), comprising:
a signal generator (three level programmable current source, element 40), configured to input a probing signal having a first frequency into a bio-impedance, wherein the probing signal comprises a three level current waveform including a plurality of sub-period current levels within one period of the first frequency, wherein the current waveform is configured to reduce at least one odd-order harmonic component of a response signal associated with the probing signal (wherein the examiner notes that the signal generated by three level current waveform generator reduces odd-order harmonics of a response signal; paragraph [0037]-[0057],[0065],[0068]-[0070], specifically [0039],[0045]-[0046],[0056]-[0057] and [0068]-[0070]; figures 2, 3A,B and 7);
a receiver (low noise amplifier (LNA), element 24), configured to receive a first response signal related to the probing signal from the bio-impedance (wherein electrodes feed measured signal to the LNA to detect voltage drop caused by excitation signal; paragraphs [0037]-[0057],[0065],[0068], specifically [0046] and [0068]);
a demodulation circuit (demodulator elements 100, 120, 122, digital part [figure 7]), coupled to the receiver (electrically coupled to LVA via multiplexer, element 30), configured to generate a first in-phase signal and a first quadrature-phase signal according to the first response signal (paragraphs [0037]-[0060],[0065] and [0068]-[0070], specifically [0044]-[0045],[0053]-[0054],[0057]-[0060],[0065], and [0069]-[0070]; figures 2, 3A,B, 7); and
a processor (external microcontroller), coupled to the signal generator and the demodulation circuit (all are electrically connected as output from chip), configured to analyze the probing signal, the first in-phase signal and the first quadrature-phase signal to determine a bio-impedance value of the bio-impedance (wherein the data/signal collected from the High Precision Impedance Sensing Integrated Circuit [HHPISic] is used to determine bioimpedance; paragraph [0006]-[0009],[0051]-[0052]; [0069]-[0071]).
However, Barrettino does not explicitly disclose the signal generator generates a probing signal having an over-sampling pattern comprising an oversampled current waveform including a plurality of sub-period current levels within one period of the first frequency.
Wasserman teaches a known signal generator for generating a multi-level signal based on a sinusoid signal wherein the multi-level signal comprises a sinusoidal waveform including a plurality of sub-period levels within one period of a frequency (sampled 6 times per cycle to produce 3 levels within a time period of the frequency) and wherein the oversampled current waveform is configured to reduce at least one odd-order harmonic component of a response signal associated with the probing signal (wherein the examiner notes that the 3rd order harmonic of the three-level waveform will be zero which would result reduction in the response signal; paragraph [0011],[0045]-[0049]; figure 3).
To summarize, Barrettino teaches generating a three-level signal probing signal at a frequency and Wasserman teaches a method and apparatus for generating a probing signal at a frequency wherein the probing signal comprises an oversampled current waveform including a plurality of sub-period current levels (in this case three) within one period of the first frequency. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Barrettino to utilize Wasserman’s known signal generator and signal generation method utilizing an oversampled current waveform as use of a known technique on a known device to yield a predictable result (Barrettino’s bioimpedance measurement device utilizing Wasserman’s signal generator to generate the three-level current signal).
Further regarding claim 2; the Barrettino/Wasserman combination as described above discloses the probing signal is a current signal and the first response signal is a voltage signal (wherein electrodes probe with a current signal and record a voltage drop; Barrettino paragraph [0037]-[0057],[0065],[0068]-[0070], specifically [0039],[0045]-[0046],[0056]-[0057] and [0068]-[0070]).
Further regarding claim 3; the Barrettino/Wasserman combination further discloses a low-pass filter (LPF element 101 and/or 102), coupled between the receiver (element 24) and the demodulation circuit (demodulation circuit elements 120 and 122), configured to filter the first response signal to generate a pre-processing signal (paragraph [0041],[0053],[0068]); wherein the demodulation circuit demodulates the pre-processing signal into the first in-phase signal and the first quadrature-phase signal (paragraphs [0045],[0060],[0069]-[0070]).
Regarding claims 11-13; Barrettino discloses A bio-impedance measurement system (figures 2, 3b, 7), comprising:
a bio-impedance (human body, element 14; paragraphs [0006]-[0009];figure 3B); and
a bio-impedance measurement device (figures 2, 3b and 7), coupled to the bio-impedance (via electrodes elements 10-13), configured to input a probing signal having three level current signal at a first frequency into the bio-impedance (via programmable signal generator, element 40), receive a first response signal related to the probing signal from the bio-impedance (via receiver element 24), generate a first in-phase signal and a first quadrature-phase signal according to the first response signal (via demodulator elements 120 and 122), and analyze the probing signal, the first in-phasesignal and the first quadrature-phase signal to determine a bio-impedance value of the bio-impedance (paragraph [0006]-[0009], paragraph [0037]-[0057],[0065],[0068]-[0071], specifically [0006]-[0009],[0051]-[0052]; [0069]-[0071]; figures 2, 3b and 7; further see rejection of claim 1 above).
However, Barrettino does not explicitly disclose the three-level current probing signal having a first frequency as having an oversampling pattern.
Wasserman teaches a known signal generator and method for generating a multi-level signal based on a sinusoid signal having an oversampling pattern wherein the multi-level signal comprises a sinusoidal waveform including a plurality of sub-period levels within one period of a frequency (sampled 6 times per cycle to product three levels within a time period of the frequency) and wherein the oversampled current waveform is configured to reduce at least one odd-order harmonic component of a response signal associated with the probing signal (wherein the examiner notes that the 3rd order harmonic of the three-level waveform will be zero which would result reduction in the response signal; paragraph [0011],[0045]-[0049]; figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Barrettino to generate the three-level probing signal having a first frequency using an oversampling pattern as taught by Wasserman as use of a known technique on a known device to yield a predictable result (in this case, Barrettino’s bioimpedance measurement system wherein the three level probing signal has an oversampling pattern as taught by Wasserman).
Further regarding claim 12; the Barrettino/Wasserman combination discloses the probing signal is a current signal and the first response signal is a voltage signal (wherein electrodes probe with a current signal and record a voltage drop; Barrettino paragraph [0037]-[0057],[0065],[0068]-[0070], specifically [0039],[0045]-[0046],[0056]-[0057] and [0068]-[0070]).
Further regarding claim 13; the Barrettino/Wasserman combination further discloses the bio-impedance measurement device is configured to filter the first response signal to generate a pre-processing signal (collected signal from LNA, element 24, before being fed to analog to digital converter, element 106; paragraph [0041],[0053],[0068]), and demodulate the pre-processing signal into the first in-phase signal and the first quadrature-phase signal (wherein I is the in phase signal and Q is the quadrature phased signal; paragraphs [0045],[0060],[0069]-[0070].
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Barrettino in view of Wasserman as applied to claims 3 and 13 above, and further in view of Li et al (CN 110974182 A, examiner relies on provided English machine translation for citation).
Regarding claims 4 and 14; The Barrettino/Wasserman combination is described in the rejection of claims 3 and 13 above; however, it does not explicitly disclose what the cutoff frequency of the low pass filter is set at.
Li teaches a system for measuring impedance wherein there is a low pass filter in the circuit wherein the low pass filer is set at lower than a predetermined multiple of the first frequency in order to obtain the DC component of the collected signal (wherein low pass filter cutoff frequency is less than 2 times the frequency of the probing signal listed as ω; page 4, paragraph starting with “as shown in FIG. 1…” of translation).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Barrettino/Wasserman combination to set the cutoff frequency at a value lower than a predetermined multiple of the first frequency (i.e. lower than 2 ω) as taught by Li in order to obtain the DC components of the collected signal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2014/0128765 A1 to Chetelat; discloses a method for measuring bioimpedance.
US 2021/0389354 A1 to Huynh; discloses a high accuracy impedance sensing circuit with increased signal to noise ratio.
US 2018/0067154 A1 to Cherkassky et al; discloses a synchronous detection circuit and method for extracting magnitude and phase from a waveform.
US 2020/0253500 A1 to Ha et al; discloses a measurement unit for measuring bioimpedance.
US 11,729,880 B1 to Thompson et al; discloses an arbitrary waveform generator for current controlled elements in electronic devices.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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