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 .
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 3-4 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.
Claim 3 claim “a device”, but it is unclear if this is referring to the device of claim 1 or is a new device that is separate.
Claim 4 claim “the device”, but it is unclear if this is referring to the device of claim 1 or the device of claim 3.
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).
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 sensor 107, 109, 207, 209 configured to couple to the device body to be positioned to be adjacent to soft tissue or hard 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).
Regarding claim 2, Kopelman discloses the sensor is configured to obtain information from the adjacent soft tissue or the adjacent hard 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 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 device 823 is disposed outside the oral cavity (Fig. 8C).
Regarding claim 5, Kopelman discloses the 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 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 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 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 includes a recess or a protrusion 908 on a surface of the device 900, and wherein the sensor 910 is configured to be coupled to the recess or the protrusion (Fig. 9, section 0097, 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).
Regarding claim 10, Kopelman discloses the recess include the protrusion 917 to push the sensor against the soft tissue or the hard tissue (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 or the protrusion 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, An outer cover 908 may hold the assembly to the aligner 904 and the apparatus may be placed over the teeth).
Regarding claim 12, Kopelman discloses the device 101, 403 includes a curved surface, wherein the sensor is an inflexible sensor, or a flat sensor, or a non-curved sensor, wherein the 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 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 or the protrusion 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 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 sensor is a photoplethysmography (PPG) sensor, 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 sensor 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).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796