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 Objections
Claim 8 is objected to because of the following informalities: Claim 8 recites “the palatal expander device using on the sensor data” which appears to mean “the palatal expander device using the sensor data” or “the palatal expander device based on the sensor data”. 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.
Claim 7 is 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 7 recites the limitation "the rate of change" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 6-12, 14, 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Belfor et al. (US 2007/0264605).
Belfor shows a palatal expander device (Fig. 1-4) comprising a palatal expander body (entirety of figures) comprising a palatal region (middle portion along the palate), and a tooth-receiving region (portion extending over and receiving teeth as in Fig. 2) configured to receive teeth of a patient’s upper arch (Fig. 2); one or more sensors ([0017], [0020-21]) disposed on or in the palatal region of the palatal expander body ([0048] discusses sensor location including at the end of the flap springs or elsewhere; sensors and their wiring to the processor being in the flap springs which extend onto the palatal region and are therefore disposed on); and at least one processor ([0050]) configured to receive sensor data from the one or more sensors ([0050] information from sensors) and to determine an expansion state of a patient’s palatal region based on the sensor data ([0021] and [0049] discuss the distance between a first portion and a second portion of the device, 12A/B for instance). With respect to claim 2, wherein the one or more sensors comprises one or more of: one or more force sensors ([0017]), one or more optical sensors, one or more strain gauges and one or more capacitive electrodes. With respect to claim 3, wherein the at least one processor is disposed on or within the palatal expander device ([0017] located on the body plate). With respect to claim 4, wherein the at least one processor is disposed on or within an electronic device remote from the palatal expander device ([0017] also discusses remote signaling to control the device and in order to generate the wireless signals a processor will be on this remote device as well; see also [0068] incorporating a computer system). With respect to claim 6, wherein the at least one processor is configured to evaluate a size of a mid palatine suture of the patient based on the sensor data (the mid palatine suture [MPS] is the bony joint that is expanded by expanders, so evaluating the change in distance between the two halves of the device across treatment will also provide an evaluation of changes in size of the mid palatine suture). With respect to claim 7, wherein the at least one processor is configured to monitor the rate of change of relative positions of a sensor emitter and a sensor receiver of the one or more sensors ([0070] discusses a database, which will include data of the relative positions over time, which is equivalent to the rate of change). With respect to claim 8, wherein the at least one processor is configured to determine a rate of expansion of the patient’s palatal region based on a change in deformation of the palatal expander device using on the sensor data (deformation of springs and/or body will result in measurements of the expansion and over time with the database, the rate thereof). With respect to claim 9, wherein the at least one processor is configured to determine an expansion force applied to the patient’s palatal region from the palatal expander device based on the sensor data ([0017], [0068], pressure being a measure of force per area). With respect to claim 10, wherein the at least one processor is configured to determine a status of the palatal expander device ([0068] status in the form of pressures applied or relative component locations) and/or a treatment plan based on the sensor data, wherein the status includes one or more of: the patient’s compliance, a condition of the palatal expander device, and an effectiveness of the palatal expander device (for instance, relative component locations provide data of the expansion effectiveness). With respect to claim 11, wherein the at least one processor is configured to determine whether to modify a treatment plan implemented by the palatal expander device based on the determined expansion state of the patient’s palatal region ([0068] discusses the sensory system determining whether to adjust one or more device components based on sensor data). With respect to claim 12, wherein the one or more sensors is configured to determine a thickness of the patient’s mid palatine raphe region (similarly to claim 6, this raphe is the tissue over the MPS, and therefore evaluating the size of the MPS will also evaluate the size/thickness of the mid palatine raphe region).
With respect to claim 14, wherein the one or more sensors and the at least one processor are configured to monitor a wear of the palatal expander device (distance between components and pressures applied will be indicative of the wear of the device as it is utilized).
Method claims 17-20 are rejected similarly to the above and additionally receiving sensor data ([0068]); monitoring the sensor data to determine an expansion state of a patient’s palate based on the sensor data ([0068]; distance between components); and outputting an indicator of the expansion state of the patient’s palate ([0068]; particularly when the system determines whether a position of one or more device components should be adjusted; also [0069]). With respect to claim 18, wherein the one or more sensors includes a pair of sensors (sensors 37 of which a pair is required to determine relative distance between plate portions), wherein the sensor data is received from the pair of sensors positioned opposite the patient’s palate (Fig. 3 for instance shows the sensors opposite the palate, where the palate is at the bottom of Fig. 3 and the sensor 37 is at the top). With respect to claim 19, wherein receiving the sensor data comprises receiving the sensor data from one or more of: one or more force sensors ([0017]), one or more optical sensors, one or more strain gauges and one or more capacitive electrodes. With respect to claim 20, wherein the monitoring comprises monitoring a rate of expansion of the patient’s palatal region based on the sensor data over a time period of greater than one day (monitoring the device over a treatment period will result in monitoring over a time period of greater than one day; [0056] discusses six months of treatment).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Belfor in view of Abolfathi et al. (US 2005/0186524).
Belfor discloses the device as previously described above, but fails to show the palatal expander device comprises a polymeric shell having a plurality of teeth-receiving cavities.
Abolfathi similarly teaches a palatal expander wherein the engagement with teeth is a polymeric shell having a plurality of teeth-receiving cavities ([0014]) and establishes this as an alternative use to archwires of the prior art ([0004]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Belfor’s device by substituting polymeric shell teeth engagement as taught by Abolfathi in order to utilize known teeth engagement alternatives in the dental expander art.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Belfor in view of Brawn (US 2017/0080249).
Belfor discloses the device as previously described above, but fails to show wherein the one or more sensors include a first sensor and a second sensor, wherein the palatal expander device is configured to determine a change in a capacitance across the first and second sensors consistent with the patient’s dental tissue compared to air or water.
Brawn similarly teaches an intraoral device having one or more sensors ([0325]) include a first sensor and a second sensor ([0325], bilateral sensors), wherein the device is configured to determine a change in a capacitance across the first and second sensors consistent with the patient’s dental tissue compared to air or water ([0324]-[0325]; senses tissue for determining when the device is placed in the mouth). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Belfor’s device to include capacitive sensors for detecting when the device is placed in the mouth as taught by Brawn in order to allow confirmation of placement in mouth and control of device based on this.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Belfor in view of Askelrod (US 2017/0340411).
Belfor discloses the device as previously described above, but fails to show wherein the one or more sensors include a first sensor and a second sensor, wherein the palatal expander device is configured to detect a change in capacitance between the first and second sensors that indicates a change in a structural integrity of the palatal expander device.
Askelrod similarly teaches an orthodontic expander ([0015]) with a first sensor and a second sensor ([0265]; “one or more of capacitive-based sensor”), wherein the palatal expander device is configured to detect a change in capacitance between the first and second sensors that indicates a change in a structural integrity of the palatal expander device ([0265]; “structural integrity”). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Belfor’s device to include sensors for detecting structural integrity as taught by Askelrod in order to allow early detection of a failing device or failed device.
Allowable Subject Matter
Claim 13 is 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of Belfor has sensors that measure a distance between device components, but does not include capacitive electrodes that are configured to sense the patient’s palatal suture opening so that the processor is configured to monitor a stage of the patient’s palatal suture opening based on the sensor data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW NELSON whose telephone number is (571)270-5898. The examiner can normally be reached on Monday-Friday 7:30am-5:00pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eric Rosen, at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW M NELSON/Primary Examiner, Art Unit 3772
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