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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/18/2025, 10/16/2025, and 02/19/2026 have been considered by the examiner.
Claims Accounting
Applicant' s arguments, filed 12/24/2025, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/24/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 3-4, 13-15, and 17-20 have been amended.
Claims 7-8, 11-12, and 16 has been canceled.
Claims 21-22 are newly presented.
Claims 1-6, 9-10, 13-15, and 17-22 are the current claims hereby under examination.
Claim Objections
Claims 1, 13, and 21-22 are objected to because of the following informalities:
In claim 1, line 3, the claim recites “a set of electrode”. This should read “a set of electrodes”.
In claim 1, line 11, the claim recites “said circuit is configured to wherein to carry out said analysis”. This should read “said circuit is configured to carry out said analysis”.
In claim 13, lines 1-2, the claim recites “said warning is provided by a member of a group consisting of visually, audibly, or tactilely and any combination thereof”. This should read “said warning is provided by a member of a group consisting of visual, audible, or tactile warnings and any combination thereof”.
In claim 21, line 2, the claim recites “two subsets of electrode”. This should read “two subsets of electrodes”.
In claim 21, lines 2-3, the claim recites “said two subsets of electrode”. This should read “said two subsets of electrodes”.
In claim 22, line 2, the claim recites “two subsets of electrode”. This should read “two subsets of electrodes”.
In claim 22, lines 2-3, the claim recites “said two subsets of electrode”. This should read “said two subsets of electrodes”.
Appropriate correction is required.
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 1-6, 9-10, 13-15, and 17-22 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.
Regarding claims 1 and 20, claim 1 recites “resolving said clusters centroids over said locations” in lines 13-14. It is unclear what the intended result of this recitation is. Par. [0160] of the published written description of the instant application teaches that Fig. 9D illustrates the contours of cluster centroids on the electrode array. It is unclear how locating the contour of the centroid cluster is analogous to spatially resolving the clusters centroids over said locations. Further, the contours of the cluster centroids overlap some of the locations, but not all of said locations. A similar recitation resulting in the same indefiniteness is found in claim 20, lines 11-12. Clarification is requested.
For the purposes of examination, “spatially resolving clusters centroids” is interpreted as any spatial mapping of the clusters and their centroids relative to the locations of the electrodes.
Regarding claim 3, the claim recites “wherein said body portion is selected from a group consisting of a portion of a head, … optionally wherein said portion of a head is a portion of a face”. As the face of a subject is a part of the head of the subject, any portion of the face would also be a portion of the head.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “portion of a head”, and the claim also recites “optionally, wherein said portion of a head is a portion of a face” which is the narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Clarification is requested.
For the purposes of examination, the claim is interpreted to include the broader limitation “portion of a head”, and any reference that includes a portion of a head is interpreted to read on the limitations of the claim.
Regarding claims 14, 15, and 17, the claims recite “A method, comprising adhering the set of electrodes of claim 1, … and operating the system while performing…”. The term “the system” lacks proper antecedent basis in the claims. It is unclear whether “the system” refers to the system of claim 1, or another system. Clarification is requested.
For the purposes of examination, claims 14, 15, and 17 are interpreted to recite “A method, comprising adhering the set of electrodes of claim 1, … and operating the system of claim 1 while performing…”.
Further regarding claims 14, 15, and 17, the claims recite “and operating the system while performing…”. It is unclear what is meant by “operating the system”. By using the interpretation of claims 14, 15, and 17 above, the system is intended to refer to the system of claim 1, however, it is unclear which functional limitations are intended to be included the step of “operating the system”. Therefore, the operating of the system of claim 1 can include any of the functional limitations as described in claim 1. Clarification is requested.
For the purposes of examination, performing any functional limitations of the system of claim 1 reads on the limitation of “operating the system” in claims 14, 15, and 17.
Further regarding claim 14, the claim recites a method comprising “operating the system while performing plastic surgery”. It is unclear what the intended purpose of this claim limitation is. The written description of the published instant application mentions plastic surgery in pars. [0017, 0036, and 0187], where it is noted that the system and methods of the present invention can be used in relation to plastic surgery. This recitation is not analogous to the system being used/operated during plastic surgery. Par. [0190] teaches that the system can be used during a surgical intervention, however it is unclear how the system would be used during a surgical intervention. More specifically, it is unclear how any portion of the operation (receiving of electrical signals, analyzing of said signals, and constructing of displayable map) of the system may be used during plastic surgery, or any surgical intervention. Clarification is requested.
For the purposes of examination, the claim is interpreted as any operation of the system during any phase of a surgery, including improvement of facial symmetry, during rehabilitation physiotherapy, and any combination thereof.
Regarding claims 18 and 19, the claims recite the limitations of “operating the system of claim 1” in lines 2 and 2, respectively. It is unclear what is meant by “operating the system of claim 1”, as there is no functional limitation in claim 1 that defines “operating”. Therefore, the operating of the system of claim 1 could include any of the functional limitations as described in claim 1. Clarification is requested.
For the purposes of examination, performing any functional limitations of the system of claim 1 reads on the limitation of “operating the system of claim 1” in claims 18 and 19.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
Claim Rejections - 35 USC § 103
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.
Claims 1-6, 13, 17, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Non-patent Literature A Wearable High-Resolution Facial… (2018) by Inzelberg et al. – previously cited (hereinafter – “Inzelberg”), in view of Non-patent Literature Increase in Heterogeneity of Biceps Brachii Activation… (2014) by Staudenmann et al., (hereinafter – “Staudemann”) in view of US Patent Publication 2019/034359 by Korzinov – previously cited (hereinafter “Korzinov”).
Regarding claims 1 and 4, Inzelberg teaches a system for determining muscle activation comprising: a set of electrodes adherable to a skin of a subject (Fig. 1 depicts the electrode array disposed on the face of a subject); and a processor in communication with the electrodes (data is processed with MATLAB (Pg. 3, par. 4), and therefore must include a processor in communication with the electrodes), and having a circuit (a processing device running MATLAB must include a circuit) configured for receiving locations of said electrodes (electrode location was used in the IC map projections (Pg. 3, par. 4), therefore the information must have been received by the processor and circuit to be used in the IC map projections) and electrical signals detected by said electrodes (sEMG data detected by electrodes (Pg. 3, par. 2); Fig. 1), analyzing said signals to identify a section of an active muscle (active muscles such as the orbicularis oculi and levator labii superioris are identified by the ICA analysis of the sEMG signals; Fig. 3), identifying locations of at least a segment of active muscles and activation patterns of said active muscles based on said identified section (active muscles are identified by the ICA analysis and the location of the muscle activation are interpolated as a JKLMN pentagon (Pg. 3, par. 5-6)), and constructing a displayable map of said locations and said activation patterns (Figs. 2-4 show displayable maps of the locations and activation patterns), wherein patterns corresponding to different active muscles are distinguishable on said map (Fig.4a. depicts clear orbicularis oculi and zygomaticus major activations (Fig. 4a. caption)), wherein said circuit is configured to carry out said analysis by applying a blind source separation algorithm to provide a plurality of data components (The ICs are a plurality of data components and are determined by applying the independent component analysis (ICA), a specific blind source separation algorithm used in sEMG analysis (Pg. 3, par. 3)).
Inzelberg does not teach applying a clustering procedure to said data components, and spatially resolving clusters centroids over said locations, wherein said clustering technique employs a k-means clustering.
Staudemann teaches a method of generating a map representative of the spatiotemporal distribution of activation of a muscle, in order to determine the effects of fatigue on muscles. The muscle activation data is collected via a plurality of electromyography electrodes, and is processed via Principal Component Analysis (PCA) (a type of blind source separation algorithm). A k-means clustering algorithm is applied to the resulting components (i.e., amplitudes) that are obtained from the PCA (Pg. 986, par. 2). The k-means clustering algorithm to identify distinct clusters within the muscles (Pg. 986, par. 2). A map of the clusters and their positions with respect to the individual electrode locations are created to visualize the changes in the anatomical locations of the clusters over time (See Fig. 5). Monitoring the EMG amplitude within and between clusters determines the consistency of the muscle activation patterns, which provides information on the recruitment process of motor units (Pg. 989, pars. 2-6).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the circuit of Inzelberg such that it is configured to apply a clustering procedure to said data components, and spatially resolve cluster centroids over said locations, wherein said clustering technique employs a k-means clustering, in order to monitor the muscle activation patterns, providing information about the recruitment of motor units over time, as taught by Staudemann (Pg. 989, pars. 2-6).
Inzelberg in view of Staudemann does not teach the circuit configured to generate a warning if a parameter is outside at least one predetermined limit.
Korzinov teaches an exercise feedback system that determines muscle fatigue measurements by using EMG signal outputs ([0031]). The system is configured to communicate an alert to the user if a parameter indicative of injury risk exceeds a set of criteria ([0054]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the circuit of Inzelberg in view of Staudemann such that it was configured to generate a warning if a parameter is outside at least one predetermined limit, in order to help avoiding injury, as taught by Korzinov ([0054]). It is noted that Staudemann also teaches the that the MUAPs can be analyzed to determine and characterize the fatigue in the muscle.
Regarding claim 2, the combination of Inzelberg, Staudemann, and Korzinov teaches the system of claim 1, wherein said map overlays an image of a body portion and/or a graphical representation of said electrodes (Inzelberg, Fig. 4 depicts the maps overlaid on the image of the body portion (face) and over a graphical representation of the electrodes.).
Regarding claim 3, the combination of Inzelberg, Staudemann, and Korzinov teaches the system of claim 2, wherein said body portion is selected from a group consisting of a portion of a neck, a portion of an arm, a portion of a leg, a portion of a hand, a portion of a foot, a portion of a torso, a portion of a head, and any combination thereof, optionally wherein said portion of said head is a portion of a face (Inzelberg, Fig. 4, the body portion is a portion of a face.).
Regarding claim 5, the combination of Inzelberg, Staudemann, and Korzinov teaches the system of claim 4, wherein said blind source separation algorithm comprises an algorithm selected from a group consisting of independent component analysis (ICA), fast independent component analysis (fastICA), principal component analysis, singular value decomposition, dependent component analysis, non-negative matrix factorization, low-complexity coding and decoding, stationary subspace analysis, common spatial pattern analysis and any combination thereof (Inzelberg; The activation maps were extracted using independent component analysis (ICA), and applied the fastICA algorithm (Pg. 3, par. 3-4)).
Regarding claim 6, the combination of Inzelberg, Staudemann, and Korzinov teaches the system according to claim 4, wherein said circuit is configured for detecting muscle unit action potential (MUAP) activity based on an output of said blind source separation algorithm.
Inzelberg teaches that ICs (the outputs of the blind source separation algorithm) have clear sEMG signals, but did not have consistent meaning from one repetition to the next. (Pg. 3, par. 5-8). The muscle unit action potentials (MUAPs) of these muscles are shown in Fig. 2a.
Regarding claim 13, the combination of Inzelberg, Staudemann, and Korzinov teaches the system according to claim 1, wherein said warning is provided by a member of a group consisting of visually, audibly or tactilely and any combination thereof (the system may communicate the notification by providing haptic feedback (Korzinov, [0054])).
Regarding claim 17, the combination of Inzelberg, Staudemann, and Korzinov teaches a method comprising operating the system of claim 1, comprising adhering the set of electrodes of claim 1 (Inzelberg, Results, par. 1 “The arrays were adhered to the left and right cheeks of healthy volunteers after a mild skin cleaning and exfoliation.”), and operating the system while performing at least one of: extracting neural control strategies, myoelectric manifestations of muscle fatigue, and myoelectric manifestations of cramps. Korizov teaches that the parameter is generated if the parameters related to fatigue exceed a predetermined threshold (See the rejection of claim 1 above). Therefore, the system is configured to be used in a method while determining myoelectric manifestations of muscle fatigue.
Regarding claim 19, the combination of Inzelberg, Staudemann, and Korzinov teaches a method comprising operating the system of claim 1, while said active muscles do not change their length or shape. Par. [0031] of Korzinov teaches that muscle fatigue may be measured during an isometric hold (i.e., the muscles do not change in length as the portion measured is not moving).
Regarding claim 20, the combination of Inzelberg, Staudemann, and Korizov teaches a method of determining muscle activation comprising: adhering a set of electrodes to a skin of a subject (Inzelberg; “The arrays were adhered to the left and right cheeks of healthy volunteers after a mild skin cleaning and exfoliation. (Pg. 2, par. 4)); and by a processor in communication with the electrodes (Inzelberg; data is processed with MATLAB (Pg. 3, par. 4), and therefore must include a processor in communication with the electrodes), receiving locations of said electrodes (Inzelberg; electrode location was used in the IC map projections (Pg. 3, par. 4), therefore the information must have been received by the processor and circuit to be used in the IC map projections) and electrical signals detected by said electrodes (Inzelberg; sEMG data detected by electrodes (Pg. 3, par. 2); Fig. 1), analyzing said signals to identify a section of an active muscle (Inzelberg; active muscles such as the orbicularis oculi and levator labii superioris are identified by the ICA analysis of the sEMG signals; Fig. 3), identifying locations of at least segments of active muscles and activation patterns of said active muscles based on said identified section (Inzelberg; active muscles are identified by the ICA analysis and the location of the muscle activation are interpolated as a JKLMN pentagon (Pg. 3, par. 5-6)), and displaying a map of said locations and said activation patterns (Inzelberg; Figs. 2-4 show displayed maps of the locations and activation patterns), and generating a warning if a parameter is outside at least one predetermined limit (Korizov, See the rejection of claim 1) , wherein patterns corresponding to different active muscles are distinguishable on said map (Inzelberg; Fig. 4a. depicts clear orbicularis oculi and zygomaticus major activations); wherein said analyzing comprises applying a blind source separation algorithm to provide a plurality of data components (Inzelberg, see the rejection of claim 1), and spatially resolving cluster centroids over said locations (Staudemann, see the rejection of claim 1).
Regarding claim 21, the combination of Inzelberg, Staudemann, and Korizov teaches the method of claim 20, wherein said set of electrodes comprises two subsets of electrodes ande the method comprising adhering said two subsets of electrodes to respective two opposite sides of a portion of said skin (Inzelberg; Fig. 1 depicts the subsets electrodes bilaterally on the face (i.e., opposite sides of a portion of said skin).
Regarding claim 22, the combination of Inzelberg, Staudemann, and Korizov teaches the method of claim 20, wherein said set of electrodes comprises two subsets of electrodes (See the rejection of claim 21 above), but does not teach wherein the method comprises adhering said two subsets of electrodes to respective two limbs of the subject.
Staudemann teaches the analysis of EMG signals and subsequently displaying of a map of the upper limbs. The map can be beneficial in order to determine the consistency of the muscle activation patterns, which provides information on the recruitment process of motor units.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Inzelberg, Staudemann, and Korizov, such that the method comprises adhering said two subsets of electrodes to respective two limbs of the subject, in order to enable the monitoring of the consistency of muscle activation patterns in muscles such as the biceps brachii in the limbs, as taught by Staudemann (Pg. 989, pars. 2-6).
Claims 9-10, 14-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Inzelberg in view of Staudemann in view of Korizov, as applied to claim 1, in view of US Patent Publication 2019/0183713 by Sankai (hereinafter “Sankai”).
Regarding claim 9, the combination of Inzelberg, Staudemann, and Korzinov teaches the system according to claim 1, but does not teach wherein said circuit is configured to access a database storing a library of activation patterns and associated control commands, to search said database for a database activation pattern matching said identified activation pattern, and to extract from said library control commands associated with said matched database activation pattern.
Sankai teaches an exoskeleton system that identifies a task phase corresponding to an EMG signal. The task phase is identified by checking the EMG signal against a reference parameter database, and a control unit selects a command function corresponding to the task phase ([0122]). This feature allows for the device to be controlled according to the subject’s intention ([0125]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the circuit of Inzelberg to be configured to access a database storing a library of activation patterns and associated control commands, to search said database for a database activation pattern matching said identified activation pattern, and to extract from said library control commands associated with said matched database activation pattern, in order to enable the control of assistive devices according to the wearer’s intention, as taught by Sankai ([0125]).
Regarding claim 10, the combination of Inzelberg, Staudemann, Korzinov, and Sankai teaches the system according to claim 9, wherein said circuit is configured to transmit said extracted control commands to an appliance. (The combination of Inzelberg, Staudemann, Korivoz, and Sankai transmits the control commands to an appliance (commands are sent to control unit 107 of wearable motion assistance apparatus (exoskeleton) 10 shown in Fig. 3 of Sankai) [0096, 0122] of Sankai).
Regarding claims 14-15 and 18, par. [0003] of Sankai teaches that the control of the exoskeleton can be applied to rehabilitation for the purpose of recovery of the motor function (i.e., rehabilitation physiotherapy). Therefore, the combination of Inzelberg, Staudemann, Korzinov, and Sankai teaches a method, comprising adhering the set of electrodes of claim 1 to a skin of a subject (Inzelberg, See the rejection of claims 1 and 20 above), and operating the system while performing plastic surgery, for a member of a group consisting of improvement of facial symmetry, during rehabilitation physiotherapy and any combination thereof. It is noted that rehabilitation physiotherapy is sometimes required after surgery, and surgery can be applicable to the lower body. Further, the combination of Inzelberg, Staudemann, Korzinov, and Sankai teaches a method, comprising adhering the set of electrodes of claim 1, and operating the system while performing a neurorehabilitation procedure, and while said subject is moving. Using the wearable motion assistance apparatus as applied for rehabilitation for the purpose of recovery of motor function comprises a neurorehabilitation procedure while the subject is moving (the device assists the motion of the subject).
Response to Arguments
Applicant’s arguments, filed 12/24/2025 have been fully considered.
The amendments to the drawings overcome the objections of record.
The amendments to the claims overcome the Double Patenting rejections of record.
The amendments to the claims do not overcome the rejections under 35 U.S.C. 112(b) of claims 3, 14-15, and 17-19.
The amendments to the claims overcome the rejection under 35 U.S.C. 101.
Applicant’s assertion regarding the rejection of claim 1 under 35 U.S.C. 102 is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
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.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791