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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 5, 11-15, 20, 37, 43, 47, and 49 are is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0060611 A1 to Radman in view of JP 2015/073749 A1 to Yamada (“Yamada”)(citation to machine translated appended and mailed with this action).
As to claim 1, Radman discloses a dental appliance comprising:
a body forming one or more tooth-receiving cavities configured to be worn on a subject’s teeth (see Fig 2, element 25 and [0041]);
a pressure sensor module coupled to the body (see Fig 2, element 32 and [0044]), wherein the pressure sensor module is configured to be held with a subject’s mouth when the one or more tooth-receiving cavities are warn on the subject’s teeth ([0044] -- “According to an aspect, the one or more pressure sensors 32 are configured to detect signs of clenching and/or grinding by the user that occur, for example, while the user is asleep.”). Radman further discloses that the pressure sensors “may be electrically and sealed and/or impervious to liquids, saliva and/or oral tissue” (see [0044]).
Radman fails to disclose wherein the pressure sensor module is a sealed pressure sensor module including an airtight encapsulated cavity, wherein the airtight encapsulated cavity is encapsulated by one or more fluid-resistant materials, wherein at least a portion of the one or more fluid-resistant materials forms a deformable surface; and
a pressure sensor encapsulated within the airtight encapsulated cavity and configured to measure an internal pressure of the airtight encapsulated cavity based at least in part on a change in volume of the airtight encapsulated cavity due to a deformation of the deformable surface,
However, in a similar invention, Yamada discloses a barometric pressure sensor attached to an intraoral dental appliance, such as a denture base or a clasp wire attached to an abutment tooth (see [0021]-[0022]), wherein the pressure sensor is sealed within a bag, such as a rubber probe cover, in which gas or liquid for transmitting pressure is enclosed (see [0012] – “…wherein the atmospheric pressure sensor is sealed in a bag.”). The rubber bag is an airtight encapsulated cavity formed of a fluid-resistant materially that forms a deformable surface, and the sensor is encapsulated within it. Pressure applied to the rubber bag deforms the bag and compresses the enclosed gas, so the sensor measures the internal pressure of the bag based on the change of volume caused by the bag’s deformation.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to seal the pressure sensor of Radmand within a gas-filled deformable rubber enclosure of Yamada in order to achieve the predictable result of preventing liquids or solids in the mouth from blocking the sensor and interfering with measurement.
As to claim 2, Radmand further discloses a processor configured to receive pressure data from the pressure sensor and configured to modify, store and/or transmit the pressure data (see Fig 2, element 50 and [0059]).
As to claim 5, Radmand further discloses a palatal region extending between a first tooth-receiving cavity and a second tooth-receiving cavity of the one or more tooth-receiving cavities (see Fig 7, element 122 and [0066]).
As to claim 11, Radmand further discloses one or more additional sensors within the sealed pressure sensor module (see [0044] – (“According to an aspect, the number of pressure sensors 32 provided is 2, 3, 4, 5, 6 or more.”) and Yamada discloses a plurality of baraometric sensors (see [0021]-[0022]). Placing an additional sensor within the same sealed module would have had the predictable result of protecting all the sensors within a single enclosure.
As to claim 12, Radmand further discloses one or more of: a temperature sensor, a photoplethysmography (PPG) sensor, a force sensor, and/or an accelerometer (see [0043]).
As to claims 13-15, Radmand in view of Yamada discloses the dental appliance of claim 1, and Yamada discloses that he sensor preferably has a diameter of approximately 0.5 mm to 10 mm and is enclosed in a rubber bag (see [0017]-[0118]). The combination does not explicitly disclose the claimed cavity volume of between about 0.1 cm3 and 100 cm3 in an uncompressed configuration, the claimed durometer of between about 20 and about 90 Shore 00, or the claimed surface area of between about 1 mm2 and 1.5 cm2. However, a bag sized to enclose a sensor of Yamada’s dimensions a volume and surface area that fall within or overlap the claimed ranges. The volume, surface area, and softness of the material are all result-effective variables in that they determine how much the enclosed gas is compressed, and thus the sensitivity of the measured internal pressure to a given deformation, as well as the size of the appliance in the mouth. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to select a cavity volume, surface area, and softness within the claimed ranges through routine optimization in order to achieve the predictable result that is a sensor that is sensitive to intraoral pressures while fitting comfortably in the mouth. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05.
As to claim 20, Radmand/Yamada disclose the invention of claim 1. Yamada further discloses that the sealed pressure sensor module can be embedded at attached to the denture base in order to reduce the foreign object feeling (see [0022] is laminated to a body forming the one or more tooth-receiving cavities (see [0044]). Radmand discloses that the mouthpiece is formed of polymers, thermoplastics, acrylics, silicone, or rubber. Lamination is a well-known technique for attached a component to a polymeric appliance body. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to laminate the sealed module to the body in order to achieve the predictable result of a secure, low-profile attachment.
As to claim 37, Radmand in view of Yamada discloses a method of monitoring intraoral pressure using a dental appliance, the method comprising:
receiving a signal from a pressure sensor sealed within an airtight encapsulated cavity of a pressure sensor module that includes a deformable surface and is coupled to a dental appliance worn by a subject, wherein the airtight encapsulated cavity is encapsulated by one or more fluid-resistant materials and wherein the pressure sensor measures an internal pressure of the airtight encapsulated cavity based at least in part on a deformation of the deformable surface; and
determining, from the signal, an intraoral pressure (see treatment of claim 1; Radman [0044], [0059] and Yamada [0018]-[0019] showing the signal is transmitted to an information processing device).
As to claim 43, Radmand further discloses determining, from the intraoral pressure, if the subject is experiencing bruxism [0044]).
As to claim 47, Radmand further discloses generating the signal by deforming a deformable outer surface of the pressure sensor module while the dental appliance is worn by the subject to change the internal pressure within the airtight encapsulated cavity (see [0044]).
As to claim 49, Radmand further discloses applying the dental appliance to the subject's mouth so that a pair of tooth-receiving portions fit onto the subject's teeth and the pressure sensor module is positioned adjacent to the subject's palate (see Fig 7).
Claim(s) 10 and 79-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmand in view of Yamada and further in view of US 2023/0277135 A1 to Kibler et al. (“Kibler”).
As to claim 10, it is not clear that Radmand discloses wherein the sealed pressure sensor module is positioned on a buccal or lingual side of the body. Radmand does, however, state that several pressure sensors may be placed in the device ([0044]). Sensor placement on a buccal or lingual side of the body was known as shown by Danno (see [0084]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the sensor of Radmand in order to achieve the predictable result disclosed by Danno of measuring perioral muscle pressures.
As to claim 79, Radmand discloses a dental appliance comprising:
a body forming one or more tooth-receiving cavities configured to be worn on a subject’s teeth (see Fig 2, element 25 and [0041]);
a pressure sensor module coupled to the body (see Fig 2, element 32 and [0044])
a power source (Fig 4, element 70);
a processor configured to receive pressure data from the pressure sensor and configured to process and store the pressure data (see Fig 7, element 50 and [0059]); and
a circuitry configured to transmit information associated with the pressure data to an external device (see [0069]),
wherein the power source and circuitry are arranged along a curve of a lingual side the body that is configured to be positioned along a lingual portion of the subject's dental arch when the one or more tooth-receiving cavities are worn on the subject's teeth (see Fig 4, elements 50 and 70).
Radmand fails to disclose the sealed pressure sensor module including an airtight encapsulated cavity that is encapsulated by one or more fluid-resistant materials, wherein at least a portion of the one or more fluid-resistant materials forms a deformable surface, and a pressure sensor encapsulated within the airtight encapsulated cavity and configured to measure an internal pressure of the airtight encapsulated cavity based at least in part on a change in volume of the airtight encapsulated cavity due to a deformation of the deformable surface. Yamada teachings this for the reasons given in the treatment of claim 1, and It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine them for the reasons discussed in the treatment of that claim.
Radmand also fails to teach wherein the sealed pressure module is further included along a curve of a lingual side of the body. Radmand does, however, state that several pressure sensors may be placed along the device (see [0044]). Sensor placement along a buccal or lingual side of the body was known as shown by Danno (see [0084]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the sensor of Radmand in order to achieve the predictable result disclosed by Danno of measuring perioral muscle pressures.
As to claim 80, Radmand fails to disclose wherein the sealed pressure sensor module, power source, and circuitry are within a pocket formed on the lingual side of the body. Radmand does, however, state that several pressure sensors may be placed in the device (see [0044]), and Yamada discloses embedding the sensor in the appliance body (see [0022]). Sensor placement on a buccal or lingual side of the body was known by Danno (see [0084]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the sensor of Radman in order to achieve the predictable result disclosed by Danno of measuring perioral muscle pressures while reducing foreign object feeling as taught by Yamada.
Claim(s) 38-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmand in view of Yamada and further in view of US 2023/0277135 A1 to Kibler et al. (“Kibler”).
As to claims 38-42, Radmand in view of Yamada discloses a method of determining intraoral pressure using an intraoral pressure sensor, but fails to disclose
wherein determining intraoral pressure further comprises determining a respiration pattern;
wherein determining intraoral pressure further comprises determining one or more of: mouth breathing, nasal breathing, snorting, and/or apnea;
wherein determining the respiration pattern comprises determining physical activity;
monitoring a patient for a respiratory disorder based on the intraoral pressure; or
determining if the intraoral pressure indicates if the subject is snoring or experiencing apnea.
However, in a very similar invention, Kibler discloses
wherein determining intraoral pressure further comprises determining a respiration pattern (see [0096] – using airflow analysis in determining sleep apnea detection inherently involves the determination of a respiratory pattern);
wherein determining intraoral pressure further comprises determining one or more of: mouth breathing, nasal breathing, snorting, and/or apnea (see [0096]);
wherein determining the respiration pattern comprises determining physical activity (see [0096] and Fig 4, element 404);
monitoring a patient for a respiratory disorder based on the intraoral pressure (see [0096] – apnea is a respiratory disorder); or
determining if the intraoral pressure indicates if the subject is snoring or experiencing apnea (determining whether intraoral pressure is indicative of apnea).
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 intraoral pressure sensing method of Kibler in order to achieve the predictable result of improving patient health by determining the existence and/or extent of sleep apnea.
Claim(s) 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmand in view of Yamada and Danno and further in view of Kibler.
As to claim 81, Radmand fails to disclose a temperature sensor that is located at an anterior position of the body. However, Kibler shows this (see Fig 2, element 120e and [0049]). 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 mouthpiece and sensors of Radmand with the temperature sensor of Kibler in order to achieve the predictable result of informing the user of fever.
Claim(s) 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radmand in view of Yamada and Danno and further in view of US 2023/0030704 A1 to Weinstein et al. (“Weinstein”).
As to claim 82, neither Radmand, Yamada, nor Danno discloses a substrate including a serpentine and/or zig-zag pattern configured to flex. However, such a substrate is shown by Weinstein (see Figs. 11a-c and [0293]). 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 mouthpiece of Radmand/Danno with the substrate having a serpentine and/or zig-zag pattern shown by Weinstein in order to achieve the predictable result of allowing considerable flex and/or stretching capabilities when connecting the various electronics of the device.
Response to Arguments
Applicants’ arguments with respect to the pending claims have been considered but are moot in view of the new grounds of rejection.
Conclusion
Applicants’ 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 Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
