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 Amendment
Applicant’s amendments of claims 33-52 are acknowledged by the Examiner.
Applicant’s amendments of claims 33, 48, and 50-52 have overcome the previous claim objections. Therefore, the claim objections are withdrawn.
Applicant’s amendments of claims 33-35, 37, 39, 42, 47, and 52 have overcome the previous claim rejections under 35 U.S.C. 112(b). Therefore, the claim rejections under 35 U.S.C. 112(b) are withdrawn.
Applicant’s amendment of claims 34-51 have overcome the previous rejections under 35 U.S.C. 112(d). Therefore, the claim rejections under 35 U.S.C. 112(d) are withdrawn.
Claims 33-52 are pending in the current Application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 33-52 have been considered but are moot because the new ground of rejection does not rely on the primary reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 33, and 49 are objected to because of the following informalities:
Claim 33 recites the limitation “for applying stimulation to the one or more muscles of the mouth” in lines 3 and 5, and “wherein a tongue of the user is located between”. Each of these limitations should be amended to include configured to language.
Claim 49 recites the limitation “for overlying at least a portion…of the user’s tongue”. This limitation should be amended to include configured to language.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 33-34, 38-42, and 47-52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sama (US 2020/0121924 A1).
In regards to claim 33, Sama discloses An apparatus (apparatus; see [0139]; see figure 1) for determining a composition of one or more muscles of a mouth of a user (impedance sensing system of the apparatus can determine or monitor the impedance across the tongue, and my be used to image the tongue muscle (see [0027-0028]), imaging of the tongue including electrical impedance tomography to monitor changes in muscle structure (see [0086])), the apparatus comprising a mouthpiece (103; see [0139]; see figure 1) including one or more first electrodes (132a-b; see [0139]; see figure 1) facing downwardly for applying electrical stimulation to the one or more muscles of the mouth of the user (see [0140]) and one or more second electrodes (133a-b; see [0139]; see figure 1) facing upwardly for applying electrical stimulation to the one or more muscles of the mouth of the user (see [0140]) wherein a tongue of the user is located between the one or more first electrodes (132a-b) and the one or more second electrodes (133a-b; see [0140]), and a sensing assembly (measuring means; see [0013]) configured or configurable to determine or measure, in use, a composition of the tongue of the user (impedance sensing system can determine or monitor tongue impedance and may be used to image the tongue (see [0027-0028]), controller may have program to conduct measurement of impedance [0039], electrical impedance tomography using electrodes generates cross sectional images of the tongue to monitor characteristic changes in muscle structure [0086], and impedance measurements may be used to produce an image to visualize the status of the tongue muscle [0185]).
In regards to claim 34, Sama discloses the invention as discussed above.
Sama further discloses wherein the sensing assembly (measuring means) further comprises an impedance sensor (impedance sensing system; see [0027], [0048], [0087], [0113]).
In regards to claim 38, Sama discloses the invention as discussed above.
Sama further discloses wherein the impedance sensor (impedance sensing system) comprises a plurality of impedance sensors (140a-b, and 141a-b; see [0141]; see figure 1; 1140a-b, and 141a-b are described as pressure sensors such as the embodiment of the measuring means described in [0014]; however, alternatively the measuring means may be impedance sensors as described in [0027]; thus, in the alternative embodiment described in [0027], 140a-b, and 141a-b are a plurality of impedance sensors).
In regards to claim 39, Sama discloses the invention as discussed above.
Sama further discloses wherein the plurality of impedance sensors (140a-b, and 141a-b) is configured to measure an impedance of the tongue at different locations on the tongue of the user (140a-b, and 141a-b are positioned at different locations of the tongue and thus, measure impedance of the tongue at different locations of the tongue).
In regards to claim 40, Sama discloses the invention as discussed above.
Sama further discloses wherein the plurality of impedance sensors (140a-b, and 141a-b) is provided on different locations on the apparatus (apparatus; see figure 1 that 140a-b, and 141a-b are provided on different locations of 103 of the apparatus).
In regards to claim 41, Sama discloses the invention as discussed above.
Sama further discloses wherein the plurality of impedance sensors (140a-b, and 141a-b) is provided at different locations on the mouthpiece (103; see figure 1).
In regards to claim 42, Sama discloses the invention as discussed above.
Sama further discloses wherein the impedance sensor (impedance sensing system) is selected from one or more of a temperature sensor, or an electromyography (EMG) sensor (the impedance sensing system uses electrodes to detect the impedance produced by the tongue (see [0086]) and thus, is selected from an EMG sensor).
In regards to claim 47, Sama discloses the invention as discussed above.
Sama further discloses wherein the sensing assembly (measuring means) comprises an impedance converter configured or configurable to convert impedance data received from the sensing assembly into user readable data (software may be programmed to using impedance sensors to generate impedance information (see [0093]), system may comprise a display for displaying data (user readable data) stored in or on at least one of the memory means (i.e. the impedance information; see [0093])).
In regards to claim 48, Sama discloses the invention as discussed above.
Sama further discloses wherein the sensing assembly (measuring means) comprises a frequency adjuster or a frequency generator configured or configurable to adjust or generate a or the frequency of electrical energy supplied to the one or more electrodes (see [0066]).
In regards to claim 49, Sama discloses the invention as discussed above.
Sama further discloses further wherein the mouthpiece (103) comprises a pair of arms (131; see [0139]; see figure 1) connected together at a connecting portion (135; see [0143]; see figure 1) and extending away from one another (see figure 1), and/or the mouthpiece (103) comprises flanges (132 and 133; see [0139]; see figure 1) for overlying at least a portion of a dorsal or a sublingual surface of the user's tongue (see [0146]).
In regards to claim 50, Sama discloses the invention as discussed above.
Sama further discloses further comprising a controller operable to alter the electrical stimulation to the one or more muscles of the mouth of the user (see [0106]).
In regards to claim 51, Sama discloses the invention as discussed above.
Sama further discloses further comprising memory (memory means; see [0074]) to hold data relating to the electrical stimulation applied to said one or more muscles of the user and/or data relating to an output of the sensing assembly (see [0107]).
In regards to claim 52, Sama discloses A method of determining a tongue composition of a person (impedance sensing system of the apparatus can determine or monitor the impedance across the tongue, and my be used to image the tongue muscle (see [0027-0028]), imaging of the tongue including electrical impedance tomography to monitor changes in muscle structure (see [0086])), the method comprising;
locating one or more first electrodes (132a-b; see [0139]; see figure 1) facing downwardly and one or more second electrodes (133a-b; see [0139]; see figure 1) facing upwardly in a mouth of the person (see [0140] that the electrodes face as claimed; see [0114] that the mouthpiece and electrodes are located in a user’s mouth);
applying electrical stimulation via the one or more first electrodes and the one or more second electrodes to one or more muscles of the mouth of the person (electrical field (i.e. stimulation) applied to the user’s tongue via 132a-b and 133a-b; see [0140]),
wherein a tongue of the user is located between the one or more first electrodes (132a-b) and the one or more second electrodes (133a-b; see [0140]); and
using a sensing assembly to determine the tongue composition of the person (impedance sensing system can determine or monitor tongue impedance and may be used to image the tongue (see [0027-0028]), controller may have program to conduct measurement of impedance [0039], electrical impedance tomography using electrodes generates cross sectional images of the tongue to monitor characteristic changes in muscle structure [0086], and impedance measurements may be used to produce an image to visualize the status of the tongue muscle [0185]).
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.
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) 35-37, and 43-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sama in view of Kasahara et al. (JP 6150331 B2) (hereinafter Kasahara; Examiner relies on a machine translation of Kasahara provided by Espacenet.com).
In regards to claim 35, Sama discloses the invention as discussed above.
Sama further discloses wherein the impedance sensor (impedance sensing system) is configured to evaluate the composition of the tongue (through electric impedance tomography) at multiple frequencies (see [0195])
Sama does not disclose the multiple frequencies is up to 100 kHz.
However, Kasahara teaches an analogous apparatus (100; see [0016]; see figure 1) for determining a composition of one or more muscles of the mouth of a user (see [0016] a tongue is a muscle of the mouth; see [0024] in reference to the determination of the composition of the user’s tongue); the apparatus (100) comprising a mouthpiece (10; see [0017]; see figure 1) including one or more electrodes (12a-b; see [0017]; see figure 1) for applying electrical stimulation to one or more muscles of the mouth of a user (see [0017]) and a sensing assembly (23; see [0022]; see figure 4) configured or configurable to determine or measure, in use, the composition of a tongue of the user (see [0023], and [0026-0028]); wherein the impedance sensor (12c) of the sensing assembly (23) is configured to evaluate the composition of the tongue (see [0026-0028] at multiple frequencies up to 100 kHz (see [0023]) for the purpose of allowing the current to flow through the internal structures of the tongue (see [0023]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the multiple frequencies for measuring the composition of the tongue as disclosed by Sama and to have utilized frequencies up to 100kHz as taught by Kasahara in order to have provided an improved apparatus that would add the benefit of providing a frequency of electrical stimulation which allows the current to flow through the internal structures of the tongue (see [0023]) thereby increasing the capability of the electrical impedance tomography disclosed by Sama to fully image the tongue.
In regards to claim 36, Sama as now modified by Kasahara discloses the invention as discussed above.
Sama further discloses wherein the sensing assembly (measuring means) is configured to evaluate the tongue composition at a single frequency overtime (the software may be programmed to generate impedance information using the impedance sensors of the measuring means during monophasic currents; see [0195]).
In regards to claim 37, Sama as now modified by Kasahara discloses the invention as discussed above.
Sama further discloses wherein the sensing assembly (measuring means) is configured to evaluate the tongue composition at multiple frequencies over time during a sampling window between 0 to 90 seconds (software program may be programmed to apply monophasic and biphasic currents having different frequencies and for different periods of predetermined time (see [0195]), and may run measurement of impedance during said period (see [0195]); said predetermined time (i.e. the sampling window) may be 1 minute (see [0194])
In regards to claim 43, Sama discloses the invention as discussed above.
Sama does not disclose wherein the sensing assembly is configured to determine or measure the tongue composition by determining or measuring a volumetric or mass ratio of muscle to fat of the tongue of the user.
However, Kasahara teaches an analogous apparatus (100; see [0016]; see figure 1) for determining a composition of one or more muscles of the mouth of a user (see [0016] a tongue is a muscle of the mouth; see [0024] in reference to the determination of the composition of the user’s tongue); the apparatus (100) comprising a mouthpiece (10; see [0017]; see figure 1) including one or more electrodes (12a-b; see [0017]; see figure 1) for applying electrical stimulation to one or more muscles of the mouth of a user (see [0017]) and a sensing assembly (23; see [0022]; see figure 4) configured or configurable to determine or measure, in use, the composition of a tongue of the user (see [0023], and [0026-0028]); wherein the sensing assembly (23) is configured to determine or measure the tongue composition by determining or measuring a volumetric or mass ratio of muscle to fat of the tongue of the user (23 through sensing provided by 12c, 12d, calculations provided by 31, and voltage provided from 24 determines the composition of the tongue using two cross sectional areas of the tongue, which are separated by a distance L, (said two cross sections depicting a mass ratio of muscle to fat; see [0036], [0039], and [0046]; see figure 9b) over which 12c and 12d are placed, and 30 consequently uses pre-programmed calculations which use the measured values for determining the tongue composition; see [0034-0050]) for the purpose of stably obtaining a predetermined measurement accuracy of the tongue composition (see [0006]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing assembly as disclosed by Sama and to have configured the sensing assembly to determine or measure the tongue composition by determining or measuring a volumetric or mass ratio of muscle to fat of the tongue of the user as taught by Kasahara in order to have provided an improved apparatus that would add the benefit of stably obtaining a predetermined measurement accuracy of the tongue composition (see [0006]).
In regards to claim 44, Sama discloses the invention as discussed above.
Sama does not disclose wherein the sensing assembly is configured to determine or measure the tongue composition by determining or measuring a total volume or mass of muscle and/or fat of the tongue of the user.
However, Kasahara teaches an analogous apparatus (100; see [0016]; see figure 1) for determining a composition of one or more muscles of the mouth of a user (see [0016] a tongue is a muscle of the mouth; see [0024] in reference to the determination of the composition of the user’s tongue); the apparatus (100) comprising a mouthpiece (10; see [0017]; see figure 1) including one or more electrodes (12a-b; see [0017]; see figure 1) for applying electrical stimulation to one or more muscles of the mouth of a user (see [0017]) and a sensing assembly (23; see [0022]; see figure 4) configured or configurable to determine or measure, in use, the composition of a tongue of the user (see [0023], and [0026-0028]); wherein the sensing assembly (23) is configured to determine or measure the tongue composition by determining or measuring a total volume or mass of muscle and/or fat of the tongue of the user (23 through sensing provided by 12c, 12d, calculations provided by 31, and voltage provided from 24 determines the composition of the tongue using two cross sectional areas of the tongue, which are separated by a distance L, (total mass of fat calculated in [0049]) over which 12c and 12d are placed, and 30 consequently uses pre-programmed calculations which use the measured values for determining the tongue composition; see [0034-0050]) for the purpose of stably obtaining a predetermined measurement accuracy of the tongue composition (see [0006]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing assembly as disclosed by Sama and to have configured the sensing assembly to determine or measure the tongue composition by determining or measuring a total volume or mass of muscle and/or fat of the tongue of the user as taught by Kasahara in order to have provided an improved apparatus that would add the benefit of stably obtaining a predetermined measurement accuracy of the tongue composition (see [0006]).
In regards to claim 45, Sama discloses the invention as discussed above.
Sama does not disclose wherein the sensing assembly is configured to determine or measure the tongue composition by determining or measuring a mass or volume of one or more types of muscle of the tongue of the user.
However, Kasahara teaches an analogous apparatus (100; see [0016]; see figure 1) for determining a composition of one or more muscles of the mouth of a user (see [0016] a tongue is a muscle of the mouth; see [0024] in reference to the determination of the composition of the user’s tongue); the apparatus (100) comprising a mouthpiece (10; see [0017]; see figure 1) including one or more electrodes (12a-b; see [0017]; see figure 1) for applying electrical stimulation to one or more muscles of the mouth of a user (see [0017]) and a sensing assembly (23; see [0022]; see figure 4) configured or configurable to determine or measure, in use, the composition of a tongue of the user (see [0023], and [0026-0028]); wherein the sensing assembly (23) is configured to determine or measure the tongue composition by determining or measuring a mass or volume of one or more types of muscle of the tongue of the user (23 through sensing provided by 12c, 12d, calculations provided by 31, and voltage provided from 24 determines the composition of the tongue using two cross sectional areas of the tongue, which are separated by a distance L, (muscle portion, and therefore a mass of the muscle portion calculated in [0049]) over which 12c and 12d are placed, and 30 consequently uses pre-programmed calculations which use the measured values for determining the tongue composition; see [0034-0050]) for the purpose of stably obtaining a predetermined measurement accuracy of the tongue composition (see [0006]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing assembly as disclosed by Sama and to have configured the sensing assembly to determine or measure the tongue composition by determining or measuring a mass or volume of one or more types of muscle of the tongue of the user as taught by Kasahara in order to have provided an improved apparatus that would add the benefit of stably obtaining a predetermined measurement accuracy of the tongue composition (see [0006]).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sama in view of Takesada (JP 2015/093133 A) (Examiner relies on a machine translation of the reference retrieved from Espacenet.com).
In regards to claim 46, Sama discloses the invention as discussed above.
Sama does not disclose wherein the sensing assembly is configured to determine or measure the tongue composition by determining or measuring a relative ratio of a first type of muscle to a second type of muscle of the tongue of the user.
However, Takesada teaches an analogous apparatus (biometric device; see [0001]) comprising an analogous sensing assembly (24; see [0013]; see figure 1) for the analogous purpose of sensing a body composition of a user utilizing an impedance of the user’s body (see [0020]) wherein the sensing assembly (24) is configured to determine or measure the body composition by determining or measuring a relative ratio of a first type of muscle to a second type of muscle of the body of the user (see [0028] in reference to the impedance measured being that of the incisor muscles, the tongue, the suprahyoid muscles, and hyoid bone muscles; thereby disclosing the sensing assembly is configured to determine the musculature composition based on fat, and the aforementioned muscles) for the purpose of performing an accurate evaluation of the measured body (see [0045]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing assembly as disclosed by Sama and to have configured the sensing assembly to measure the tongue composition by measuring first and second types of muscles of the body of the user as taught by Takesada in order to have provided an improved sensing assembly that would add the benefit of being able to sense a relative ratio of multiple muscle types for the purpose of performing an accurate evaluation of the measured body (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 DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL A MILLER/ Primary Examiner, Art Unit 3786
Prosecution Insights