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, see pages 8-11, filed 5/25/2026, with respect to 1-12,15-17,19 and 21-22 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Seidl (US 2012/0089045 A1) in view of Kandori (US 2008/0306373 A1).
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.
Claim(s) 1-5, 17, 19, 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seidl (US 2012/0089045 A1) in view of Kandori (US 2008/0306373 A1).
Regarding claim 1, Seidl discloses A method for providing auxiliary information on dysphagia using voice analysis (eg. Para. 19), the method comprising: obtaining, via a sensor array, a pre-food swallowing voice or vibration and a post-food swallowing voice or vibration of a subject (eg. Para. 19), respectively; wherein the auxiliary information on dysphagia comprises characteristic information about a residue state concerning one or more of the following: whether food has been aspirated into an airway after food swallowing by the subject, the presence or absence of residues, the location of residues, and the amount of residues (eg. Para. 98-112); and applying, by an electrical stimulator, electrical stimulation to a neck region of the subject to assist swallowing of the subject, based on the characteristic information on the residue state (eg. Para. 96-112) but does not disclose providing auxiliary information on dysphagia by comparing one or more characteristic values of each of the voice or vibration (eg. Para. 98-110, Seidl uses a mix of voltages/impedance but not vocal/vibration).
Kandori teaches a sensor device (eg. Para. 33, 43, Fig. 1, microphone 103) that determines a level of dysphagia (eg. Fig. 4A-C, Para. 22-24, 45-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Seidl with the microphone and dysphagia detection as taught by Kandori since both are in the realm of using microphones to assess swallowing and would provide the predictable result of an additional way of determining the severity of dysphagia from sounds.
Regarding claim 2, the combined invention of Seidl and Kandori discloses each of the sensors of the sensor array is attached to a residue site of interest of the subject (eg. Kandori, Para. 8, the step comprises: calculating one or more characteristic values from each of the pre-food swallowing voice or vibration and the post-food swallowing voice or vibration of the subject obtained by each of the sensors by sites on the subject; and comparing one or more characteristic values of each of the pre-swallowing voice or vibration and the post-swallowing voice or vibration obtained at the same site, to calculate characteristic information on the residue state, comprising one or more of following: whether food has been aspirated into the airway after the subject's food swallowing, the presence or absence of residues, the site of residues, and the amount of residues (eg. Kandori, Fig. 4A-C, Para. 22-24, 45-50).
Regarding claim 3, the combined invention of Seidl and Kandori discloses each of sensors of the sensor array comprises at least a microphone (eg. Kandori, Para. 33, 43, Fig. 1, microphone 103).
Regarding claim 4, the combined invention of Seidl and Kandori discloses each of the sensors of the sensor array further comprises a vibration sensor that senses vibration (eg. Kandori, Para. 8-9, 14, 88).
Regarding claim 5, the combined invention of Seidl and Kandori discloses providing further information on one or more of the following: whether food has been aspirated into the airway and whether residues remain in the pharynx, based on the characteristic information about the residue state (eg. Seidl, Para. 19, 98-112; and Kandori, 45-53).
Regarding claim 17, the combined invention of Seidl and Kandori discloses the residue sites of interest are at least one or more of the subject's lips, the skin surface near the vallecular pouch, the skin surface near the vocal cord, the skin surface near the pyriformis sinus, and the skin surface near the pharyngeal wall, of the subject's neck (eg. Seidl, Para. 6, 19, 23; Kandori, Para. 7, 11, Fig. 1 and 3).
Regarding claim 19, the combined invention of Seidl and Kandori discloses the electrical stimulator is a 4-channel electrostimulator, and the applying of the electrical stimulation comprises adjusting parameter values of the 4-channel electrostimulator, based on at least one of whether food has been aspirated into the airway, the amount of the aspirated food,
whether residues remain in the pharynx, and the amount of residue remaining in the pharynx (eg. Seidl, Para. 106-108, multichannel stimulator).
Regarding claim 21, the combined invention of Seidl and Kandori discloses the subject is a dysphagia patient, and the auxiliary information on dysphagia comprises auxiliary information on the improvement of dysphagia (eg. Seidl, Para. 106-114; Kandori, Para. 89).
Regarding claim 22, the combined invention of Seidl and Kandori discloses obtaining, via the sensor array, at least a first voice or vibration and a second voice or vibration, respectively, after subject's food swallowing, with the second voice or vibration obtained after a period of time has elapsed from the first voice or vibration; and comparing one or more characteristic values of each of the pre-food swallowing voice or vibration, the first post-swallowing voice or vibration, and the second post-swallowing voice or vibration of the subject obtained at the same site to provide characteristic information on the residue state (eg. Kandori, Para. 10-11, 68 and Seidl, Para. 50, compares to baseline parameters to track progress).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seidl (US 2012/0089045 A1) in view of Kandori (US 2008/0306373 A1), further in view of Rogers (US 2021/0113099 A1).
Regarding claim 10, the combined invention of Seidl and Kandori discloses the invention of claim 1, but does not disclose voice or vibration is a voice or vibration when the subject utters a specific word for a period of time.
Rogers teaches identifying letters words associated with specific vibrations for swallowing assessment (eg. Para. 161, 230).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Seidl and Kandori with the word identification for swallowing assessment as taught by Rogers since both are in the realm of learning trends in swallowing or difficulty swallowing and would provide the predictable result of detecting aspiration if a person cannot speak words properly.
Claim(s) 11-12, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seidl (US 2012/0089045 A1) in view of Kandori (US 2008/0306373 A1), further in view of Kang (“Detection of voice changes due to aspiration via acoustic voice analysis”, 2018).
Regarding claim 11, the combined invention of Seidl and Kandori discloses the invention of claim 1, but does not disclose the one or more characteristic values are calculated using a PRAAT.
Kang teaches detecting voice changes due to aspiration via acoustic voice analysis by collecting voice parameters using PRAAT (eg. Abstract, Section 2.3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the invention of Seidl and Kandori with the acoustic parameter calculation as taught by Kang since PRAAT is a commonly known technique in the art for acoustic analysis.
Regarding claim 12, the combined invention of Seidl, Kandori, and Kang discloses the one or more characteristic values comprise one or more selected from the group consisting of average fundamental frequency (F0) for all extracted pitch periods of voice or vibration, standard deviation of the fundamental frequency, relative average perturbation (RAP), jitter, shimmer percentage, amplitude perturbation quotient (APQ), noise-to-harmonic ratio (NHR), harmonics to noise ratio (HNR), voice turbulence index (VTI), and signal to noise ratio (SNR) (eg. Kang, Abstract, Section 2.3).
Regarding claim 15, the combined invention of Seidl, Kandori, and Kang discloses if the relative average perturbation (RAP) of the post-food swallowing voice or vibration increases or decreases compared to the pre-food swallowing voice or vibration obtained by the sensor attached to the same site, the residue location is determined to be near the sensor attachment site, and it is determined that the amount of residue is large in the region close to the site where the RAP variability is greatest among the sites to which the sensor is attached, by comparing the RAP variability of the pre-food swallowing voice or vibration and the post-food swallowing voice or vibration obtained by each of the sensors by sites on the subject (eg. Kang Section 3-4).
Regarding claim 16, the combined invention of Seidl, Kandori, and Kang discloses if at least one of jitter, shimmer percentage, and voice turbulence index of the post-swallowing voice or vibration increases or decreases compared to the pre-food swallowing voice or vibration, the residue location is determined to be near the sensor attachment site, and it is determined that the amount of residue is large in the region close to the site where the variability is greatest among the sites to which the sensor is attached, by comparing the variability of at least one of jitter, shimmer percentage, and voice turbulence index of the pre-food swallowing voice or vibration and the post-food swallowing voice or vibration obtained by each of the sensors by sites on the subject (eg. Kang, Section 3-4).
Allowable Subject Matter
Claim 6-9 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/MICHAEL J LAU/Examiner, Art Unit 3796
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