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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 1, 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on December 1, 2025. As directed by the amendment: claim(s) 1 and 17 have been amended, claim(s) 2-3, 5, 7-9, 13-16, 18, 20, and 22-25 have been cancelled, and claim(s) 26-27 have been added. Thus, claims 1, 4, 6, 10-12, 17, 19, 21 and 26-27 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pgs. 11-12, filed December 1, 2025, with respect to the 35 U.S.C. 112(a) rejection of claims 1, 4, 6, 10, 17, 19, 21 and 24-25 have been fully considered and are persuasive. The 35 U.S.C. 112(a) rejection of claims 1, 4, 6, 10, 17, 19, 21 and 24-25 has been withdrawn.
Applicant's arguments filed December 1, 2025 have been fully considered but they are not persuasive. The applicant principally argues that the claims are not directed to an abstract idea and the claims provide limitations directed to a practical application of the alleged abstract idea. The examiner respectfully disagrees. Firstly, the applicant argues that the claim is not directed to a mental process and that measuring changes in electrical conductivity via impedance and through skin of the ear necessitates physical electronics and cannot be performed in the human mind. The examiner would like to note that the “necessitation” of physical electronics does not preclude it from being a mental process. The use of these sensors and computer elements are merely additional elements that are generic as detailed in the 35 U.S.C. 101 rejection below that are simply used to perform the mental process. Essentially, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Furthermore, the details in MPEP 2106.04(a)(2)(III)(A) state that examples of claims that do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions includes: a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). The claims as written is merely collecting impedance information, analyzing it, and transmitting certain results of the collection and analysis.
Secondly, the applicant argues that the claims recites a specific arrangement and use of hardware to solve a concrete, sensor-domain problem. However, it is unclear to the examiner that there is a specific arrangement the claims recite “wherein at least one of the plurality of sensor regions is configured to engage an ear canal region, and at least one of the plurality of sensor regions is configured to engage a concha region of the ear, an anti-tragus region of the ear, or a region of the ear between the anti-tragus region and an acoustic meatus region. There appears to be a substantial amount of arrangements that can be utilized to achieve the desired results of the claims. Furthermore, the MPEP 2106.05(a)(II) states that improvements to the technology or technical fields may be sufficient to show an improvement including: Particular configuration of inertial sensors and a particular method of using the raw data from the sensors, Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017). However, the claims as written only require the processor to convert the signals to physiological data and does not detail any particular method of using the data from the sensors.
Therefore, the examiner is not convinced and the 35 U.S.C. 101 rejection of the claims is maintained and further detailed below.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27 has a limitation “earpeice module” which is misspelled and should read “earpiece module.”
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.
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: audible device in claim 26.
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.
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 § 112
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 26-27 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 26 contains the limitation “…an audible device connected with the housing of the earpiece module...” However, it is unclear what the audible device is as this term is not utilized in the instant specification. The examiner has interpreted this as the communications and entertainment module as the claim requires communicating audibly with the subject. If this is incorrect, clarification and correction is required.
Claim 27 contains the limitation “…communicating audibly with the subject, using the earpiece module…” However, it is unclear how this audible communication with the subject is done and what is being utilized to communicate with the subject. The examiner has interpreted this as the communications and entertainment module being utilized for communicating audibly with the subject. If this is incorrect, clarification and correction is required.
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, 4, 6, 10, 17, 19, 21, and 26-27 are rejected under 35 U.S.C. 101 because the claimed invention details a system and method (Step 1) directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 1, 4, 6, 10, 17, 19, 21, and 26-27 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 1, 4, 6, 10, 17, 19, 21, and 26-27 recites at least one step or instruction for monitoring a subject, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). Accordingly, each of Claims 1, 4, 6, 10, 17, 19, 21, and 26-27 recites an abstract idea.
Specifically, Claim 1 recites
An earpiece module, comprising:
a housing configured to be positioned within an ear of a subject, the housing comprising a plurality of sensor regions, (additional element) each sensor region contoured to matingly engage a respective different region of an ear of a subject, wherein at least one of the plurality of sensor regions comprises at least one electrical conductivity sensor configured to use impedance to measure changes in electrical conductivity through skin of the ear of the subject, and wherein the at least one electrical conductivity sensor is configured to monitor at least one cardiovascular physiological function of the subject selected from heart rate, pulse rate, blood flow, blood pressure, or a heartbeat signature; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
at least one motion sensor configured to detect subject motion; (additional element)
at least one signal processor (additional element) supported by the housing, wherein the at least one signal processor is configured to subtract, in real-time, motion noise information detected by the at least one motion sensor from signals from the at least one electrical conductivity sensor at each of the plurality of sensor regions, and wherein the at least one processor is configured to convert, in real-time, the signals into physiological data; and (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
a transmitter supported by the housing, (additional element) the transmitter configured to wirelessly transmit the physiological data to a remote device (additional element), wherein at least one of the plurality of sensor regions is configured to engage an ear canal region, and at least one of the plurality of sensor regions is configured to engage a concha region of the ear, an anti- tragus region of the ear, or a region of the ear between the anti-tragus region and an acoustic meatus region.
Additionally, Claim 17 recites
A method of monitoring a subject via an earpiece module, the earpiece module having at least one motion sensor (additional element), at least one signal processor (additional element), a transmitter (additional element), and plurality of sensor regions, each sensor region having at least one electrical conductivity sensor (additional element) configured to measure changes in electrical conductivity, the method comprising:
positioning the earpiece module within an ear of the subject, wherein each sensor region is contoured to matingly engage a respective different region of the ear, and wherein at least one of the plurality of sensor regions engages an ear canal region, and at least one of the plurality of sensor regions engages a concha region of the ear, an anti- tragus region of the ear, or a region of the ear between the anti-tragus region and an acoustic meatus region; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
detecting or measuring at least one cardiovascular physiological function of the subject selected from heart rate, pulse rate, blood flow, blood pressure, or a heartbeat signature via impedance using the at least one electrical conductivity sensor at each of the plurality of sensor regions; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
measuring subject motion via the at least one motion sensor; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
processing, in real-time via the at least one signal processor, signals produced by the at least one motion sensor to provide motion noise information; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
converting, in real-time via the at least one signal processor, signals from the at least one electrical conductivity sensor at each of the plurality of sensor regions into physiological data that can be transmitted wirelessly by the transmitter; and (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
transmitting, via the transmitter, the physiological data and the motion noise information to a remote device (additional element).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1 and 17 (and their respective dependent claims 4, 6, 10, 19, 21, and 26-27) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1 and 17), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: housing, motion sensor, signal processor, a transmitter, and sensor regions having at least one electrical conductivity sensor are generic and used for data gathering adding insignificant extra-solution activity to the judicial exception in independent Claims 1 and 17 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1 and 17 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., external programming device or computer as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 17 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 17 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 1, 4, 6, 10, 17, 19, 21, and 26-27 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: housing, motion sensor, signal processor, a transmitter, and sensor regions having at least one electrical conductivity sensor. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s instant specification , pg. 16 lines 27-30, the housing may be formed from various materials such as metal, rubber, wood, various forms of plastic and etc. which details the wide variety of materials available that are generic and commercially available. Per Applicant’s instant specification, pg. 5 lines 11-16 details the use of motion sensors may include sensors that measure changes in one or more of the following; inertia, capacitance, electrical conductivity and etc. with such generality that they are generic and commercially available. Further, in applicant’s specification pg. 15 lines 16-26 the signal processor may be composed of various signal conditioners, amplifiers, , filters, transistors, microprocessors and etc. described as generic computer parts that can be combined to create a signal processor. Per Applicant’s specification, pg. 15 lines 26-34 and pg. 16 lines 1-6 details a transmitter/receiver device that can be a sonic or ultrasonic transmitter, antenna and details that a variety of sonic and ultrasonic receivers and transmitters are available in the marketplace and can be utilized. Lastly, the sensor regions having at least one electrical conductivity sensor are detailed in the instant specification pg. 21 lines 22-26 details the sensor region can be an electrical conductivity sensor or an electrode and further on pg. 20 lines 5-11 which details the sensors can be a physiological sensor, environmental sensor, such as an optical sensor which details that there is a variety of sensors that can utilized with such generality that they are generic and commercially available.
Furthermore, Shalon (US 2006/0064037 A1) discloses in [0284] a system that can measure heart rate (i.e. cardiovascular physiologic function) utilizing one or more of a variety of sensors at various regions of the external or internal ear and ear canal. Additionally, Moroney (US 2010/0179389 A1) discloses in [0027] a sensor member that may be utilized inside the concha of the outer ear, the outer ear, earlobe, and/or the ear canal. Both of these prior arts, detail how it is well-understood, routine, conventional activity in the art to utilize a variety of arrangements of sensors within the ear to capture cardiovascular physiological function of the subject.
Accordingly, in light of Applicant’s specification, the claimed term processor is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for computers. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1 and 17 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and system of Claims 1, 4, 6, 10, 17, 19, 21, and 26-27 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 17 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1, 4, 6, 10, 17, 19, 21, and 26-27 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1, 4, 6, 10, 17, 19, 21, and 26-27 are not patent eligible and rejected under 35 U.S.C. 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough January 16, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796