DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 recites “a machine learning algorithm” in lines 3-7, but lacks detail in the specification. It appears that the only detail of a machine learning algorithm is in ¶ [0098]. However, there is no mention of any detail of the actual structure of the algorithm. As such, the specification does not reasonably convey that, at the time the application was filed, the inventor had possession of the claimed invention. Further clarification is required.
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.
Claim 9 recites “a machine learning algorithm trained . . . receives as input . . . and outputs a prediction,” in lines 3-7, but is indefinite because the algorithm appears to be a black box with not structure of the input, governing equations, and outputs (¶[0098]).
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea.
STEP 1
Regarding claim 17, the claim recites a series of steps or acts, including determining a contextual property of the biological tissues based on a frequency-dependent variation between the free space reflection coefficient and the another reflection coefficient across the plurality of frequency points. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining a contextual property of the biological tissues based on a frequency-dependent variation between the free space reflection coefficient and the another reflection coefficient across the plurality of frequency points sets forth a judicial exception. This step describes a mathematical concept that is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number. Thus, the claim is drawn to a Mathematic Concept, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. There is no element that indicates or provides an improvement to the technological field, the method does not effect a particular treatment or effect a particular change, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of using an antenna to measuring multiple reflection coefficients at a plurality of frequency points via first and second set of port-reflection measurements, determining a contextual property based on the reflection coefficients, and calculating a permittivity value. Using an antenna to measuring reflection coefficients, determining contextual properties, and calculating permittivity values are well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the measuring, determining, and calculating steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited antenna is a generic sensor configured to perform pre-solutional data gathering activity, and the computer system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data processing and alert generation. The measuring, determining, and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7-10, 13, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Constantine et al. (US 20190388000- Previously cited), hereinafter Constantine.
Regarding claims 1, 10, and 17, Constantine teaches an apparatus comprising: a display (¶ [0192], “those skilled in the art will appreciate that the inventive methods can be practiced with other computer system configurations, including . . . , microprocessor-based or programmable consumer electronics” indicating that a display can be included); an antenna (fig. 1A-D, antenna array); a transceiver circuitry coupled to the antenna (see fig. 1A-C); and a processing circuitry coupled to the transceiver circuitry (¶ [0076,0090,0190], “The signal measured from the antenna is converted using a computer program that allows the transformation of the magnitude and the phase of the reflected and/or transmitted signals into concentration of the blood constituents via trained models” ) and configured to:
measure a first reflection coefficient of the antenna in free space at a plurality frequency via a first set of port-reflection measurements;
measure a second reflection coefficient of the antenna when the antenna is proximate biological tissues at the plurality of frequency points via second port reflection measurements (¶[0065, 0076,0080,0091,0110,0189] and figs. 3C-D and 54A-C, “the antenna is used to transmit electromagnetic waves into human tissues in areas in close proximity to the main palmar veins in order to better monitor and detect the variation of the concentration of the blood constituent,” “S11 parameters are detected including, but not limited to: Magnitude, and Phase or impedance, and to derive the Power level,” and “The antenna resonates when it is loaded with a typical human hand tissue to increase its sensitivity to the variation of the blood constituents. The human hand tissue comprises a skin layer, fat layer, blood layer, muscle layer and bone layer. The antenna is operational at multiple frequencies” (emphasis added)), and
determine the contextual property is based on a frequency-dependent variation between the first reflection coefficient and the second reflection coefficient across the plurality of frequency points (Constantine teaches body constituents are determined based on the reflection coefficients, e.g., first, second, obtained at multiple frequencies (dependent on the frequency variations). ¶[0120,0189], “reflection coefficient S11 phase and magnitude measurements obtained for a given antenna (rigid or flexible) at multiple frequencies are used for the estimation of glucose levels” and “a mathematical model is developed to directly relate reflection coefficient measurements to glucose level concentrations, thereby allowing one to non-invasively predict glucose level concentrations via the respective antenna measurements” (emphasis added)),
wherein the frequency-dependent variation is converted to a permittivity value corresponding to a substance concentration within the biological tissues (¶[0097], “the shape of our antenna improves its sensitivity to the variation of permittivity hence the variation of glucose levels” and “The shift between the S11 corresponding to a permittivity 60 and that of the 80 is 0.6 MHz” indicating conversion to a permittivity value corresponding to glucose concentration).
Regarding claims 2 and 18, Constantine teaches wherein the contextual property includes a measured substance concentration within the biological tissues or a physical characteristic of the biological tissues (¶ [0073-74], a plurality of biomarkers, their concentrations, and related to the physical characteristic are measured).
Regarding claim 3, Constantine teaches wherein the contextual property includes blood glucose level (¶0072).
Regarding claims 7 and 13, Constantine teaches wherein the antenna is configured to transmit a radio frequency signal (¶ [0072]).
Regarding claim 8, Constantine teaches determining the contextual property of the biological tissues based on a curve fitting algorithm applied to data points captured from measurements of the first reflection coefficient and the second reflection coefficient, wherein the curve fitting algorithm maps a variation between the first reflection coefficient and the second reflection coefficient to a plasma permittivity value. (see fig. 19A-C and ¶ [0097,0132], “the variation of permittivity hence the variation of glucose levels” and “the S11 fitted curve showing the trend of the antenna's response when the glucose levels increase. These S11 values are recorded at different frequencies, corresponding to the highest correlations between the S11 and the glucose reference levels. These features and others are used for the estimation of BG levels through GP regression.” ¶[0112], Moreover, the permittivity corresponds blood permittivity because “The sensor is connected to a signal processing system to convert the magnitude and/or the phase into concentration of the blood constituents” and “Predictive modeling for selection of critical features”).
Regarding claim 9, Constantine teaches wherein the processing circuitry is configured to determine the contextual property based on machine learning algorithm that maps a variation between the first reflection coefficient and the second reflection coefficient based on a plasma permittivity value, wherein the plasma permittivity value corresponds to the contextual property of the biological tissues (¶[0097,0108,0120-121], “the shape of our antenna improves its sensitivity to the variation of permittivity hence the variation of glucose levels,” “The shift between the S11 corresponding to a permittivity 60 and that of the 80 is 0.6 MHz”, and “ Different regression techniques are tested to best identify the most suitable models that capture the underlying variation in glucose level” indicating conversion to a permittivity value corresponding to glucose concentration. ¶[0112], Moreover, the permittivity corresponds blood permittivity because “The sensor is connected to a signal processing system to convert the magnitude and/or the phase into concentration of the blood constituents” and “Predictive modeling for selection of critical features” (emphasis added)).
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 4-6, 11-12, 14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Constantine, as applied to claims 1, 10, 13 and 17, further in view of Charthad (US 20220131424- previously cited).
Regarding claims 4-5, 11-12, and 19-20, Constantine fails to teach wherein the circuitry is configured to provide an indication regarding a position of the antenna and whether the biological tissues are correctly positioned relative to the antenna.
Charthad teaches a system, device, and method for monitoring physiological parameters of a user by establishing and maintaining reliable link between devices, tissue interference, and movement of the device (¶[0003]). Charthad further teaches using machine learning to determine the physiological parameters (¶[0116-19,0219]), Additionally, S11 parameters can be monitored to determine whether the device is sufficiently coupled to the user to aid in guiding inexperienced users (¶[0404,0417-18]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Constantine, such that the circuitry is configured to provide an indication regarding a position of the antenna and whether the biological tissues are correctly positioned relative to the antenna, as taught by Charthad, to aid in guiding inexperienced users.
Regarding claims 6 and 14, Constantine teaches two or more antennas coupled to the processing circuitry and wherein the processing circuitry is configured to measure reflection coefficients for each of the two or more antennas (¶ [0063], “the two antenna prototypes are placed on the volunteer's hands and readings are taken simultaneously from both antennas”).
Response to Arguments
Applicant's arguments filed 04/06/2026 have been fully considered but they are not fully persuasive.
Applicant’s arguments related to Ertin, Nevermann, and Simpkin have been considered but are moot because amendments require new grounds of rejection.
Applicant argues that Constantine fails to overcome the deficiencies of the above references, on page 12 of the Remarks. Examiner disagrees. Applicant fails to provide any reasoning as to why Constantine is deficient, thus the argument is moot in view of the applied rejection above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shafi teaches techniques that characterize human skin permittivity at different frequency spans and leverage EM principles to differentiate between healthy and anomalous skin lesions. US 20220385315
Cespedes teaches a sensing mechanism based upon a shift in the antenna resonant frequency as a function of change in glucose levels which electrically manifests itself as a change in blood permittivity and conductivity. US 10478101
Fahimi teaches distribution of the material and properties (i.e., permittivity, permeability, and conductivity) is provided for the phantom (for gland, fat and tumor). However, these quantities can be computed from analyzing the reflection and absorption coefficients. US 20240065612
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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