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 Objections
Claim 8 is objected to because of the following informalities: Claim 8 recites “ ( ” in line 7, but instead should be replaced with a comma. Appropriate correction is required.
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.
Claims 8-9 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 8 recites “a mathematical algorithm that establishes a relationship between the contextual property of the biological tissues and a variation between the first reflection coefficient and a body proximity reflection coefficient” and “curve fitting of measured reflection coefficient data to a model relation reflection coefficient variation to tissue permittivity” in the last two lines, but “a relationship,” “a model,” and “tissue permittivity” lack detail in the specification. As best understood by the specification (see para. [0044-48]), “a relationship” is “between ΔVSWR and plasma permittivity, where ΔVSWR is the difference between the antenna reflection coefficient in free space and in the presence of the finger.” As such, the relationship as claimed is materially different because it is not of the contextual property of the biological tissue and variation between the coefficients. Rather, the relationship appears to be between the difference of the coefficients (ΔVSWR) and plasma permittivity. Moreover, “a model” that forms the mathematical algorithm lacks detail because it is unknown which model is being referenced (see para. [0048], a lookup table is mentioned but a lookup table is not considered a model). Lastly, there is no mention of “tissue permittivity” in the specification, thus, it is unclear what is being referenced.
Claim 9 recites “a machine learning algorithm trained . . . receives as input . . . and outputs a prediction,” in lines 3-7, but lacks detail in the specification. It appears that the only detail of a machine learning algorithm is in para. [0098]. However, there is no mention of training, input, outputting, and/or any detail of the actual structure of the algorithm.
Further clarification is required for the above.
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.
Claims 8-9 are 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 8 recites “a mathematical algorithm that establishes a relationship between the contextual property of the biological tissues and a variation between the first reflection coefficient and a body proximity reflection coefficient” and “curve fitting of measured reflection coefficient data to a model relation reflection coefficient variation to tissue permittivity” in the last two lines, but is indefinite. As best understood by the specification (see para. [0044-48]), “a relationship” is “between ΔVSWR and plasma permittivity, where ΔVSWR is the difference between the antenna reflection coefficient in free space and in the presence of the finger.” As such, it is not clear how the relationship is established and with what components. Additionally, it is unclear what “a model,” and “tissue permittivity” are referring to since the specification fails to explicitly or implicitly contain the subject matter.
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. Moreover, the components recited in the limitation are not referenced in the specification (see para. [0098]).
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 1-2, 4-7, and 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ertin et al. (US 20210290074- Previously cited), hereinafter Ertin, further in view of Nevermann (20030062907- Previously cited) and Simpkin (US 20070073144).
Regarding claim 1, Ertin teaches an apparatus comprising: a display (see para. [0055-56], “The computing device(s) 1103 may include, for example, one or more display devices” and “the bodily monitoring system 100 may be directly connected to the computing device 1103”); an antenna (see fig. 2 and para. [0031], antenna array); a transceiver circuitry coupled to the antenna (see fig. 1A-C); and a processing circuitry coupled to the transceiver circuitry (see para. [0030], processing circuitry 127) and configured to:
measure a first reflection of the antenna; measure a second reflection coefficient of the antenna when the antenna is proximate biological tissues (see abstract, multiple reflection coefficients for each tissue interface is determined);
and determine contextual property of the biological tissues based on a comparison between the first reflection coefficient and second reflection coefficient (see para. [0053], the coefficients are compared and analyzed to determine tissue location and characteristics, e.g., fluid level).
Ertin fails to teach wherein the first reflection coefficient of the antenna in free space is measured.
Nevermann teaches a device that is configured to determine a reflection coefficient when the device is proximate biological tissue and a reflection coefficient for the antenna in free space, compare the coefficients, and determine that the antenna is in proximity to a body and aid in unnecessary exposure of the user or other persons to radio frequency radiation and controlling the device accordingly (see para. [0002-3,0025] and abstract).
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 Ertin, such that the first reflection coefficient of the antenna is measured in free space, as taught by Nevermann, to aid in unnecessary exposure of the user or other persons to radio frequency radiation and controlling the device accordingly. Additionally, the modification is merely applying a known technique (reflection coefficient of antenna in free space) to a known device (radiofrequency based device) ready for improvement to yield predictable results.
Ertin-Nevermann fail to teach wherein the measurements of the first and second reflection coefficients at a plurality of frequency points via a first and a second set of port-reflection measurements; and that the comparison is based on the plurality of frequency points.
Simpkin teaches an imaging system for generating a three dimensional image of a body part using an antenna system (see abstract, the generated of the body part is considered the contextual property of the biological tissue). A reflection coefficient is determined, using the antenna system, for all frequencies in a free space and when next to the patient (see para. [0074,0091,0105], “Each antenna element in the linear array is switched on in turn and the reflection coefficient determined for all frequencies” and “the radiation information is obtained at each scan location by repeating the measurement over a broad range of frequencies”).
As such 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 Ertin-Nevermann, such that the measurements of the first and second reflection coefficients at a plurality of frequency points via a first and a second set of port-reflection measurements, as taught by Simpkin, to aid in generating contextual property of the biological tissue.
Regarding claims 2 and 18, Ertin teaches wherein the contextual property includes a measured substance concentration within the biological tissues or a physical characteristic of the biological tissues (see para. [0029], “determine other bodily characteristics such as thoracic fluid levels”).
Regarding claims 4-5, 11-12 and 19-20, Ertin teaches 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 (see para. [0031], “Feedback can be provided to the user to adjust the position of the sensor if necessary to provide adequate coupling with the bodily tissue” indicating that user is notified of correctly positioned antennas relative to bodily tissue).
Regarding claims 6 and 14, Ertin 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 (see para. [0049], “control the RX switching matrix 115 to receive the reflected backscatter by the corresponding RX antenna in each pair” indicating each antenna pair is controlled to obtain reflection coefficients).
Regarding claims 7 and 13, Ertin teaches wherein the antenna is configured to transmit a radio frequency signal (see para. [0028]).
Regarding claim 9, Ertin teaches wherein the processing circuitry is configured to determine the contextual property based on machine learning algorithm trained on measured reflection coefficient data, wherein the machine learning algorithm receives as input the variation between the first reflection coefficient and the body proximity reflection coefficient, and outputs a prediction of the contextual property of the biological tissues (see para. [0041-43,0053], “The properties of the skin, fat, muscle, lung and/or other tissue are modeled and estimated in order to estimate the permittivity of the lung tissue that can be used to determine lung water or fluid content. Considering a multi-layer model for the tissues through which the EM waves propagate (e.g., skin, fat, and muscle), such as the one illustrated in FIG. 5A, the lung parameters (e.g., thickness and composition) can be estimated.” and “The mathematical model for the interface (e.g., skin, fat, muscle and/or bone) is non-parametric and can be learned from the sensor data itself with no prior information on the thickness and order of the tissues”, indicating that a machine learning algorithm is used to aid in determining the contextual property; see para. [0048-52], “With the reflection profiles and reflection coefficients determined for the P sets of backscatter data, the computing device can track the lung position and characteristics” and “reflection coefficients can be determined from the reflection profile” indicating that a body/organ proximity reflection coefficient is obtained to determine organ/body position since the coefficients are required to make the determination).
Claim 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ertin in view of Nevermann and Simpkin, as applied to claim 2, further in view of Constantine et al. (US 20190388000- Previously cited), hereinafter Constantine.
Regarding claim 3, Ertin-Nevermann-Simpkin fail to teach wherein the contextual property includes blood glucose level.
Constantine teaches a mathematical model 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 (see para. [0157]).
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 Ertin-Nevermann, such that the contextual property includes blood glucose level, as taught by Constantine, as it would merely be applying a known technique (determine glucose based on reflection coefficients) to improve similar devices (body monitoring device) in the same way.
Regarding claim 8, Ertin teaches wherein the processing circuitry is configured to determine the contextual property based on an algorithm or machine learning algorithm to establish a relationship between the contextual property of biological tissues and a variation between the first reflection coefficient and a body proximity reflection coefficient, measured when the antenna is proximate the biological tissues (see para. [0041-43,0053], “The properties of the skin, fat, muscle, lung and/or other tissue are modeled and estimated in order to estimate the permittivity of the lung tissue that can be used to determine lung water or fluid content. Considering a multi-layer model for the tissues through which the EM waves propagate (e.g., skin, fat, and muscle), such as the one illustrated in FIG. 5A, the lung parameters (e.g., thickness and composition) can be estimated.” and “The mathematical model for the interface (e.g., skin, fat, muscle and/or bone) is non-parametric and can be learned from the sensor data itself with no prior information on the thickness and order of the tissues”, indicating that a machine learning algorithm is used to aid in determining the contextual property; see para. [0048-52], “With the reflection profiles and reflection coefficients determined for the P sets of backscatter data, the computing device can track the lung position and characteristics” and “reflection coefficients can be determined from the reflection profile” indicating that a body/organ proximity reflection coefficient is obtained to determine organ/body position since the coefficients are required to make the determination).
Ertin-Nevermann-Simpkin fail to teach wherein the mathematical algorithm comprises curve fitting of measured reflection coefficient data to a model relating reflection coefficient variation to tissue permittivity.
Constantine teaches curve fitting the reflection coefficient variation to the glucose (see fig. 19A-C and para. [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”).
Thus, 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 Ertin-Nevermann-Simpkin, such that the mathematical algorithm comprises curve fitting of measured reflection coefficient data to a model relating reflection coefficient variation to tissue permittivity, as taught by Constantine, to aid in estimating a contextual property of the biological tissue (glucose).
Response to Arguments
Applicant's arguments filed 09/04/2025 have been fully considered but they are not fully persuasive.
Applicant’s arguments with respect to 35 U.S.C. 112(a), 112(b), and 103 rejections of claims have been considered but are moot because amendments require new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yang teaches a system and method for classifying body activities through an on-body antenna measuring changes in reflected power and the resulting reflection coefficients, in contrast to two antenna systems that measure transmission power therebetween. US 20170360323 A1
Simpkin teaches calculating the monostatic scattered electric field due to the skin layer for the scan location based on the reflection coefficients of all the surface segments. US 20100069744 A1
Natesan teaches a measurement device is configured to measure at least a first complex value indicative of an impedance matching of the first antenna and a second complex value indicative of an impedance matching of the second antenna. US 20170070246 A1
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791