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 .
Response to Arguments
Applicant’s arguments filed 2/4/2026 have been considered but are moot in view of the new ground(s) of rejection as necessitated by the applicant’s claim amendments.
112 Rejection
The applicant’s amendment overcame the examiner’s previous 112. It is now clear the anatomical model generated “by reconstructing internal tissue conductivity based on the EIT measurement, wherein the EIT measurement constitutes a medical image of the limb”. The examiner has withdrawn the 112(b) rejection. However, upon further inspection the newly introduced claim language “by reconstructing internal tissue conductivity based on the EIT measurement, wherein the EIT measurement constitutes a medical image of the limb” creates a written description issue (see the 112(a) rejection below).
101 Rejection
The addition of the calibrating step overcomes the 101 rejection and thus the 101 rejection has been vacated.
Prior Art
Applicant’s arguments filed 2/4/2026 have been considered but are moot in view of the new ground(s) of rejection as necessitated by the applicant’s claim amendments. In particular, the examiner is now making a 103 rejection using Barachant in view of Ruffini to address the new limitation requiring “generating, using a processor, an anatomical model of a limb by reconstructing internal tissue conductivity based on the EIT measurement, wherein the EIT measurement constitutes a medical image of the limb”.
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 1-20 are 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.
In particular, the phrases “anatomical model” in claim 1, 15, and all dependent claims thereof and “finite element model” in claim 2 in conjunction with the new language “by reconstructing internal tissue conductivity based on the EIT measurement, wherein the EIT measurement constitutes a medical image of the limb” lack sufficient written description in the specification. MPEP 2161.01 states “Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
Upon inspection of the applicant’s specification, the applicant attempts to incorporate by reference an application (see par. [0018]) for the Finite Element Model but only provides the title and not the actual application number. 37 CFR 1.57(d) states that "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. 37 CFR 1.57(d) further states that "Essential material" is material that is necessary to provide a written description of the claimed invention. Therefore, a reference to an application title is not sufficient to provide written description support for the limitations of “anatomical model” and “finite element model” since the actual application serial number is not provided. Without the application serial number, it is unclear whether or not the cited title is referencing a published U.S. patent application and determination of whether the algorithm or steps/procedure taken to perform the function.
Thus, the newly introduced claim language “by reconstructing internal tissue conductivity based on the EIT measurement, wherein the EIT measurement constitutes a medical image of the limb” creates a written description issue. In particular, the applicant has the functional result (“reconstructing internal tissue conductivity based on the EIT measurement”) claimed but do not disclose the steps/algorithm (see the 112(a) rejection for the “anatomical model”) for actually accomplishing the result. Per MPEP 2161.01, “...claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
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.
Claim(s) 1, 2, 4, 7, 10-13, 15, 17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barachant (WO 2020/112986 A1) in view of Ruffini et al. (WO 2018/195157 A1); hereinafter referred to as “Ruffini”. For the purpose of prior art rejections, US 2020/0129119 A1 has been used as an equivalent document for WO 2018/195157 A1.
Regarding claims 1 and 15, Barachant discloses a method for calibrating an electrode array, the method comprising: receiving an electrical impedance tomography (EIT) measurement receiving an electrical impedance tomography (EIT) measurement obtained by injecting electrical current and sensing voltages using a plurality of electrodes of an electrode array positioned on a limb (e.g. see [0066]); generating, using a processor, an anatomical model of a limb (e.g. see [0053], “computer-based musculoskeletal representation associated with a hand”); determining an alignment of the electrode array relative to anatomical structures represented in the anatomical model based on the EIT measurement (e.g. see [0079], [0081]. [0079] discloses “some embodiments use autocalibration to automatically detect the position of the wearable device on a body part using an autocalibration model”, [0081] discloses “autocalibration model(s) can be used to determine the orientation and/or positioning of the band on the user’s body part, e.g., forearm”); comparing the determined alignment of the electrode array with a reference alignment associated with a reference anatomical model (e.g. see [0054], [0069]); estimating one or more spatial alignment variations of the electrode array relative to the anatomical structures using an alignment variation model (e.g. see [0054], [0069]. Note: [0054] discloses “In certain embodiments, the systems and methods disclosed herein comprise identifying a “virtual” reference electrode and mapping the specific orientation of an armband to an offset value associated with an electrode and the “virtual” reference electrode” while [0069] discloses “in certain embodiments, the armband system can be calibrated via selection of particular inference model(s) such that the system adapts to any rotation and/or arm position offset without interfering with the user experience, also referred to herein as autocalibration. In other embodiments, the detected offset in orientation and/or relative difference in location of the band on the user compared to the orientation and/or positioning of the band used to train one or more inference models can be used to “normalize” the orientation and/or location of the band for input into the inference model(s). A virtual reference electrode (e.g., the“0” electrode) may be defined, and a rotation offset relative to the virtual reference electrode may be used to normalize the orientation and/or location of the band”), and calibrating the electrode array based on the estimated one or more spatial alignment variations by modifying operation of the electrode array (e.g. see [0054], [0069]).
Barachant discloses generating, using a processor, an anatomical model of a limb (e.g. see [0053], “computer-based musculoskeletal representation associated with a hand”) but is silent as to generating, using a processor, an anatomical model of a limb by reconstructing internal tissue conductivity based on the EIT measurement, wherein the EIT measurement constitutes a medical image of the limb. Ruffini teaches it is known to use such a modification as set forth in [0021]-[0023] to provide a multilayer finite element model of a realistic head that may be either generic or specific to a patient (e.g. see [0021]. Note: Claim 2 specifies the anatomical model is a finite element model). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to generate an anatomical model by reconstructing internal tissue conductivity based on the EIT measurement as taught by Ruffini in the system/method of Barachant, since said modification would provide the predictable results of a multilayer finite element model of a realistic head that may be either generic or specific to a patient.
Regarding claim 2, Barachant discloses the claimed invention except for the anatomical model is a finite element model. Ruffini teaches it is known to use such a modification as set forth in [0021] to provide a multilayer finite element model of a realistic head that may be either generic or specific to a patient (e.g. see [0021]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a finite element model in the calibration process as taught by Ruffini in the system/method of Barachant, since said modification would provide the predictable results of a multilayer finite element model of a realistic head that may be either generic or specific to a patient.
Regarding claims 4 and 20, Barachant discloses automatically adjusting a pattern of the electrode array to accommodate the one or more alignment variations using an alignment adjustment function (e.g. see “autocalibration” in [0054], [0069], [0079], [0081]).
Regarding claims 7 and 17, Barachant discloses the limb is a forearm (e.g. see [0054], [0069], [0081]).
Regarding claim 10, Barachant discloses the alignment variation model is a shared response model or a domain adaptation model (e.g. see [0054], [0070], [0075]. The examiner is interpreting the models trained on multiple users as a “shared response model”).
Regarding claim 11, Barachant discloses machine learning is used to improve alignment variation model (e.g. see [0067], [0068], [0070], [0075]).
Regarding claim 12, Barachant discloses the machine learning comprises a deep learning model (e.g. see [0068]).
Regarding claim 13, Barachant discloses the one or more alignment variations comprise one or more of a distal shift or a proximal shift (e.g. see [0069]).
Regarding claim 19, Barachant discloses the electrode array is configured to perform electromyography (e.g. see [0054], [0061]-[0064])
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.
Claim(s) 5-6, 8-9, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barachant in view of Ruffini as applied to claims 1, 4, and 15 above, and further in view of Friedenberg et al. (Pub. No.: US 2021/0353942 A1); hereinafter referred to as “Friedenberg” (NOTE: Please see provisional application 63/024,589 for a date that precedes the applicant’s application priority data).
Regarding claim 5, Barachant in view of Ruffini discloses method and system for calibrating an electrode array as set forth above. Barachant further discloses autocalibration (e.g. see [0054], [0069], [0079], [0081]) but is silent as to automatically adjusting the pattern of the electrode array comprises sending one or more signals to the electrode array to shift a pattern of active electrodes and inactive electrodes. Friedenberg teaches that it is known to use such a modification as set forth in [0045] to provide an iterative calibration process (e.g. see [0014]) that lacks many of the drawbacks of previous calibration techniques (e.g. see [0011]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to shift a pattern of active electrodes and inactive electrodes as taught by Friedenberg in the system/method of Barachant in view of Ruffini, since said modification would provide the predictable results of an iterative calibration process (e.g. see [0014]) that lacks many of the drawbacks of previous calibration techniques (e.g. see [0011]).
Regarding claim 6, Barachant discloses the one or more alignment variations using an alignment adjustment function (e.g. see “autocalibration” in [0054], [0069], [0079], [0081]) but is silent as to manually adjusting a pattern of active electrodes and inactive electrodes of the electrode array. Friedenberg teaches that it is known to use such a modification as set forth in figure 8, [0074]-[0077] to provide an iterative calibration process (e.g. see [0014]) that lacks many of the drawbacks of previous calibration techniques (e.g. see [0011]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use manually adjust the electrode pattern as taught by Friedenberg in the system/method of Barachant in view of Ruffini, since said modification would provide the predictable results of an iterative calibration process (e.g. see [0014]) that lacks many of the drawbacks of previous calibration techniques (e.g. see [0011]).
Regarding claims 8, 9, and 16, Barachant discloses the claimed invention except for the electrode array is located on an internal surface of a garment and the method is performed following a donning of the garment. Friedenberg teaches that it is known to use such a modification as set forth in [0007], [0086] (for the internal surface limitation) and [0078] (for the donning limitation) to provide superior skin contact for the electrodes (e.g. see [0007], [0086]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use electrodes located on the inside of the garment and performing the method following the donning as taught by Friedenberg in the system/method of Barachant in view of Ruffini, since said modification would provide the predictable results of superior skin contact for the electrodes (e.g. see [0007], [0086]).
Regarding claim 14, Barachant discloses the claimed invention but is silent as to optimizing the electrode current of the electrode array. Friedenberg teaches that it is known to use such a modification as set forth in figure 2, [0056]-[0057], [0061] to provide reduced discomfort/pain when adjusting current amplitude for choosing the right electrode energization pattern (e.g. see [0061]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize the current of the electrode array as taught by Friedenberg in the system/method of Barachant in view of Ruffini, since said modification would provide the predictable results of reduced discomfort/pain when adjusting current amplitude for choosing the right electrode energization pattern (e.g. see [0061]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barachant in view of Ruffini as applied to claim 15 above, and further in view of Sharma et al. (Pub. No.: US 2020/0406035 A1); hereinafter referred to as “Sharma”.
Regarding claim 18, Barachant in view of Ruffini discloses method and system for calibrating an electrode array as set forth above. Barachant further discloses the claimed invention but is silent as to the electrode array is a high-density electrode array. Sharma teaches that it is known to use such a modification as set forth in figure 1, element 12, [0020] to provide an electrode sleeve with high channel density and large coverage area that allows for the classification of more complex hand movements (e.g. see [0045]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize the current of the electrode array as taught by Sharma in the system/method of Barachant in view of Ruffini, since said modification would provide the predictable results of an electrode sleeve with high channel density and large coverage area that allows for the classification of more complex hand movements (e.g. see [0045]).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/P.C.E/Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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