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 .
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kopelman (US 20190099129), cited previously.
Regarding claim 1, Kopelman discloses a device body 101 configured to couple to dentition (Fig. 1A-B, section 0054, the soft tissue sensor systems described herein may include an intraoral appliance shaped to receive a patient's teeth within a cavity and to secure the intraoral appliance against the patient's teeth); and a photoplethysmography (PPG) sensor 107, 109, 207, 209 (section 0100, photoplethysmogram (PPG) sensor may measure blood-volume changes in the blood tissue) configured to couple to the device body to be positioned to be adjacent to soft tissue in an oral cavity when the device body couples to the dentition (Figs. 1A-B, 2A-B, section 0056, the soft tissue sensor 107, 109, 207, 209 shown in this example is held in a sensor mount 105 that is formed in or connected integrally with, the intraoral appliance); wherein the device body 101 comprises a protrusion protruding 105 from a surface of the device body 101 to push the PPG sensor 107 against the soft tissue (Figs. 1A-B, section 0056-0057).
Regarding claim 2, Kopelman discloses the PPG sensor is configured to obtain information from the adjacent soft tissue when the device body couples to the dentition (Section 0068, non-penetrating microneedles (probes) may be used for a particular sensor, and the probe may be configured to contact the surface of the tissue without penetrating. The sensor may be configured to include multiple sensing features, including electrical (e.g., conductance, resistance, etc.), mechanical (vibration, deflection, etc.), chemical, thermal (temperature sensing, etc.), or the like).
Regarding claim 3, Kopelman discloses a communication device configured to be operably linked to or connected to the sensor to receive the obtained information (Section 0082, communicate in one-way or two-way communication with a remote (e.g., external) device, such as an external processor (e.g., smartphone, computer, wearable electronics, pad, etc.)).
Regarding claim 4, Kopelman discloses the communication device 823 is disposed outside the oral cavity (Fig. 8C, Section 0082, communicate in one-way or two-way communication with a remote (e.g., external) device, such as an external processor e.g., smartphone, computer, wearable electronics, pad, etc.).
Regarding claim 5, Kopelman discloses the PPG sensor 107, 109, 207, 209 is configured to be coupled to the device 101 to be at least partially exposed to an outer surface of the device (Figs. 1A-B, section 0056, the soft tissue sensor 107 shown in this example is held in a sensor mount 105 that is formed in or connected integrally with, the intraoral appliance).
Regarding claim 6, Kopelman discloses the PPG sensor 107, 109, 207, 209 is configured to contact or be positioned to be close to the soft tissue or the hard tissue in the oral cavity (Fig. 1A-B, section 0056, the soft tissue sensor includes two microneedles that extend way from the intraoral appliance, towards the gingiva, so that the microneedles may contact the gingiva when the soft tissue sensor system is worn on the patient's teeth).
Regarding claim 7, Kopelman discloses the PPG sensor is a flexible sensor (section 0160, any of the biosensors described herein may include one or more microfluidics systems. any of these microfluidic systems may include hard or flexible/stretchable (such as silicone) materials).
Regarding claim 8, Kopelman discloses the PPG sensor is not expandable or stretchable (Figs. 2A-B, section 0016, 0061, The microneedle may be fabricated from any appropriate material, including metal, silicon (or silicon dioxide), polymer, etc., including combinations of these. the sensor is roughly rectangular with two microneedles 209 extending from the base of the sensor and out of the holder so that they may engage with the target, e.g., the gingiva ).
Regarding claim 9, Kopelman discloses the device 900 includes a recess 906, and wherein the sensor 910 is configured to be coupled to the recess 906 (Fig. 9, section 0097, 0148, the apparatus 900 includes an orthodontic device, shown as an aligner 904 to which a biosensor or biosensors are coupled. An outer cover 908 may hold the assembly to the aligner 904 and the apparatus may be placed over the teeth. the monitoring device 902 is coupled to a tooth receiving cavity 906 for a molar).
Regarding claim 10, Kopelman discloses the recess 906 include the protrusion 917 (Section 0098, he microneedle(s) are extending from an outer surface of the aligner, in some variations some or all of the microneedles may extend from an inner surface of the aligner and into the gingiva or may sample from the saliva above the gingiva).
Regarding claim 11, Kopelman discloses the recess 906 includes a slot, a groove, or an insert, and wherein the sensor is configured to be coupled to the slot, the groove, or the insert (section 0097, 0148, An outer cover 908 may hold the assembly to the aligner 904 and the apparatus may be placed over the teeth. the monitoring device 902 is coupled to a tooth receiving cavity 906 for a molar).
Regarding claim 12, Kopelman discloses the device 101, 403 includes a curved surface, wherein the PPG sensor is an inflexible sensor, or a flat sensor, or a non-curved sensor, wherein the PPG sensor 407 is positioned in the device with respect to the curved surface of the device (Fig. 4, section 0073, sensor 407 is mounted into the intraoral appliance forming the intraoral, soft-tissue sensor system 403, and the teeth fit snugly into the cavity formed by the intraoral appliance).
Regarding claim 13, Kopelman discloses the curved surface of the device corresponds to a curve of a dental arch in the oral cavity (Fig. 4, section 0073, sensor 407 is mounted into the intraoral appliance forming the intraoral, soft-tissue sensor system 403, and the teeth fit snugly into the cavity formed by the intraoral appliance).
Regarding claim 14, Kopelman discloses the device 300 includes data storage 704 operably linked to or connected to the PPG sensor 706 (Fig. 7A, section 0084, The biosensor(s) 733 may be separate from the electronics system 735 (indicated by the dashed lines. For example, the biosensor(s) may be part of a second oral appliance and/or directly mounted in the oral cavity (e.g., on a tooth/teeth), and may couple to an oral appliance including all or some of the electronics system (e.g., battery/power source 716, processor 702, antenna 712, memory 704, etc.).
Regarding claim 15, Kopelman discloses the data storage is built into a Radio Frequency Identity (RFID) chip 755 (section 0085, communications circuitry (shown as an RFID front end 755) or Near-Field Communication (NFC) chip.
Regarding claim 16, Kopelman discloses the recess has a buccal lingual thickness from about 0.5 to about 15 mm deep (section 0131, a monitoring device has a height or thickness less than or equal to about 1.5 mm, or less than or equal to about 2 mm. In some embodiments, a monitoring device has a length or width less than or equal to about 4 mm, or less than or equal to about 5 mm).
Regarding claim 17, Kopelman discloses a maximum distance between a surface of the PPG sensor facing toward the soft tissue or the hard tissue and an outer surface of the device is from about 0.5 mm to about 5 mm (Section 0016, The microneedle may extend from a base or substrate by any appropriate length (e.g., between 0.5 mm and 5 cm, e.g., between 0.5 cm and 4 cm, between 0.5 mm and 3 cm, between 0.5 mm and 1 cm, between 0.5 mm and 9 mm, between 0.5 mm and 8 mm, between 0.5 mm and 7 mm, between 0.5 mm and 6 mm, between 0.5 mm and 5 mm, etc.).
Regarding claim 18, Kopelman discloses the device further comprises a physiological sensor, a physical sensor, a chemical sensor, a proximity sensor, a vibration sensor, or a positional sensor (Section 0100, apparatuses may include a sensor configured as a physiological sensor to detect one or more subject physiological state. For example, any of the apparatuses or methods described herein may measure (e.g., using a physiological sensor) one or more of: electrocardiogram (ECG), bio-impedance, blood oxygenation, galvanic skin response, heart rate, body temperature, respiration (including respiration rate), or the like. For example, any of these apparatuses may include an ECG sensor (e.g., one-point ECG electrode), a thermistor, a bio-impedance sensor, a photoplethysmogram sensor, a galvanic skin response sensor).
Regarding claim 19, Kopelman discloses the device includes a silicone, plastic, a liquid crystal polymer (LCP) substrate, an LCP base material adhered to a cladding, a fiber or a yarn, paper (optionally comprising cellulose nanofibers (CNFs), a polyaniline nanofiber/graphite nanofiber (PANI/GNF) nanocomposite, or a polyaniline (PANI) supportive matrix, or a combination thereof (Section 0016, The microneedle may be fabricated from any appropriate material, including metal, silicon (or silicon dioxide), polymer, etc., including combinations of these).
Regarding claim 20, Kopelman discloses the device is a mandibular advancement device (MAD), or an orthodontic device, or a device that repositions a mandible or a maxilla (section 0083, All or some of these components may be on or part of an oral appliance, such as an aligner, brace, palatal expander).
Response to Arguments
Applicant's arguments filed 6/26/2026 have been fully considered but they are not persuasive. Examiner finds that the sensor 107 of Kopelman discloses is a PPG sensor as shown in section 0100 in Kopelman and the sensor 107 is a soft tissue sensor that can be pushed against soft tissue found in the mouth since it is located on an aligner as seen in Kopelman Figs. 1A-B.
Conclusion
THIS ACTION IS MADE FINAL. 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 JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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