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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 12, 2026 has been entered.
Response to Amendment
In response to amendments, filed February 12, 2026, claims 1 and 2 have been amended. No additional claims have been added or cancelled. Claims 1-19 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed February 12, 2026, with respect to the prior art rejections of claim(s) 1-19 have been considered but are moot because the new grounds of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Sarvazyan (US 20080221484 A1), Borotto (US 20170265978 A1), Gonzales (US 20200197785 A1), and Severson (US 3943915 A).
Claim Objections
Claim 16 is objected to because of the following informalities: “based a distance” should be “based on a distance.” 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 1-19 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.
In Claim 1, the limitation “a sensor cover having a first principal surface and a second principal surface that opposes the first principal surface” is unclear as to whether the opposing surface is the first principal surface of the first pressure sensor or of the sensor cover. Examiner is interpreting it to be referring to be of the sensor cover, and if that is the applicant’s intent, the limitation should be updated to “a sensor cover having a first principal surface and a second principal surface that opposes the first principal surface of the sensor cover.” By virtue of dependency, claims 2-19 are also rejected.
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(s) 1-9 and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarvazyan (US 20080221484 A1) in view of Borotto (US 20170265978 A1).
Regarding claim 1, Sarvazyan teaches an oral pressure measurement device ([0003] “mechanical imaging of palpable tissues, including but not limited to, through natural body openings in a human being, i.e. mouth;” probe 3, fig. 2) comprising:
a handle comprising a rod-like outer shape that extends along a first axis (Fig. 2, handle 24);
and a sensor extending from the handle ([0058] “head pressure sensor array 1 installed on a probe head 21, and with the shaft pressure sensor array 2 installed on a probe shaft 22 attached to the probe handle 24”) and including:
a first pressure sensor having a first principal surface and configured to measure pressure, a second pressure sensor having a second principal surface and configured to measure pressure ([0058] “head pressure sensor array 1 installed on a probe head 21, and with the shaft pressure sensor array 2 installed on a probe shaft 22 attached to the probe handle 24”),
a first flat plate disposed above the first principal surface of the first pressure sensor, a second flat plate disposed above the second principal surface of the second pressure sensor and that is separately arranged from the first flat plate (Fig. 2, head pressure sensor array 1 and shaft pressure sensor array 2; Fig. 3A, pressure sensors 31 on probe head constitute the pressure sensing matrix of the head pressure sensor array 1; Fig. 3B, pressure sensors 32 on probe shaft 22 constitute the shaft pressure sensor array 2. [0071] “Each individual pressure sensor may be a piezoelectric, resistive, or quantum tunnelling composite pressure transducer, but in the preferred embodiment it is a capacitive transducer.”).
However, Sarvazyan fails to disclose a sensor cover with opposing, parallel principal surfaces with the pressure sensor principal surfaces each being parallel to at least one of the principal surfaces of the sensor cover.
Borotto teaches devices, systems and methods exploiting capacitive means for monitoring and analysing teeth-related parameters in a subject, such as the dental occlusion profile and/or the load/force applied upon clenching.
Borotto discloses and a sensor cover having a first principal surface and a second principal surface that opposes the first principal surface, with the first principal surface of the sensor cover being parallel to the second principal surface of the sensor cover, wherein the first pressure sensor and the second pressure sensor are incorporated in the sensor cover between the first principal surface and the second principal surface of the sensor cover ([0037] “FIG. 6 depicts an exploded view of a sensor array (middle image) sandwiched between two shield layers as the one depicted in FIG. 4, further comprising two shielding pads (top and bottom images).” [0097] "This electrical performance variation is processed by a set of micro-controllers in order to calculate the load position and the relative intensity. The force applied to each sensor is computed independently." [0102] “PDMS has been used for the encapsulating layers (the external ones)”), and
wherein the first pressure sensor and the second pressure sensor are coupled to the sensor cover in a fixed configuration such that the first principal surface of the first pressure sensor and the second principal surface of the second pressure sensor are each parallel to at least one of the first principal surface and the second principal surface of the sensor cover (Fig. 13, metallic pads parallel to encapsulation layers; [0043] “FIG. 12 depicts a device of the invention shaped as a dental fork. Array of sensors are placed in the biting region and opportunely connected with micro-controllers.”).
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 system of Sarvazyan to include a sensor cover with opposing, parallel principal surfaces and the pressure sensor principal surfaces each being parallel to at least one of the principal surfaces of the sensor cover as disclosed in Borotto to result in a cleaner and more reliable signal from the sensor pads, which are parallel to the dental occlusion plane (Borotto [0066]). This configuration enables revealing of dental contact points and can therefore provide a precise, qualitative spatial measure of the dental occlusion, thus permitting to an operator such as a clinician to estimate a possible malocclusion and tailor a therapy accordingly (Borotto [0069]).
Regarding claim 2, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 1, wherein the first principal surface of the first pressure sensor is parallel to and coplanar to the second principal surface of the second pressure sensor (Borotto: Fig. 12; [0043] “FIG. 12 depicts a device of the invention shaped as a dental fork. Array of sensors are placed in the biting region and opportunely connected with micro-controllers.” [0066] “an array of pads are embedded within the support substrate and disposed in a planar fashion, in parallel to the dental occlusion plane”).
Regarding claim 3, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 1, wherein the sensor further includes: a first elastic body disposed above the first flat plate and a second elastic body disposed above the second flat plate and that is separately arranged from the first elastic body (Sarvazyan: Fig. 2 below, head pressure sensor array 1 installed on a probe head 21, and with the shaft pressure sensor array 2 installed on a probe shaft 22; [0067] “each pressure sensor includes a capacitive pressure transducer covered by an elastic compound.”).
Regarding claim 4, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 1, wherein the first pressure sensor and the second pressure sensor are aligned along the first axis (Sarvazyan: Fig. 2 shown below, head pressure sensor array 1, shaft pressure sensor array 2, handle 24; Borotto: annotated Fig. 12 below; [0066] “an array of pads are embedded within the support substrate and disposed in a planar fashion, in parallel to the dental occlusion plane”).
Regarding claim 5, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 4, wherein the first principal surface of the first pressure sensor and the second principal surface of the second pressure sensor are parallel to the first axis (Sarvazyan: Fig. 2 shown below, head pressure sensor array 1, shaft pressure sensor array 2, handle 24; Borotto: annotated Fig. 12 below; [0066] “an array of pads are embedded within the support substrate and disposed in a planar fashion, in parallel to the dental occlusion plane”).
Regarding claim 6, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 1, wherein the first pressure sensor and the second pressure sensor are aligned along a second axis that intersects the first axis (Sarvazyan: Fig. 2 shown below, head pressure sensor array 1, shaft pressure sensor array 2, handle 24; Borotto: annotated Fig. 12 shown below; [0066] “an array of pads are embedded within the support substrate and disposed in a planar fashion, in parallel to the dental occlusion plane”).
Regarding claim 7, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 6, wherein the first principal surface of the first pressure sensor and the second principal surface of the second pressure sensor are parallel to both the first axis and the second axis (Sarvazyan: Fig. 2 shown below, head pressure sensor array 1, shaft pressure sensor array 2, handle 24; Borotto: annotated Fig. 12 shown below; [0066] “an array of pads are embedded within the support substrate and disposed in a planar fashion, in parallel to the dental occlusion plane”).
Regarding claim 8, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 7, wherein the sensor comprises an outer shape that includes a first portion that extends from the handle along the first axis and a second portion that extends from the first portion along the second axis (Sarvazyan: Fig. 2 shown below, head pressure sensor array 1, shaft pressure sensor array 2, handle 24; Figs. 3A/B below; Borotto: annotated Fig. 12 shown below; [0066] “an array of pads are embedded within the support substrate and disposed in a planar fashion, in parallel to the dental occlusion plane”).
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Annotated Borotto Fig. 12 shows the pressure sensors parallel to both the first axis and second axis, displayed as intersecting dotted lines
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Sarvazyan Fig. 2 shows portions of the sensor to extend from the handle along the first axis and Figs. 3A/B show the width of sensor portions extending from the first portion along the second axis.
Regarding claim 9, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 1, further comprising a controller configured to receive a first measurement value from the first pressure sensor and a second measurement value from the second pressure sensor (Sarvazyan: Fig. 5, processor 52; [0075] “A pressure sensing circuit inside the electronic unit 6 comprises an analog switching unit 45, amplifier 46, converter and/or integrator 49, designed to amplify and convert respective electrical signals generated by each pressure sensor for detecting a pressure imposed on each sensor during prostate examination. Analog-to-digital converter 48 transforms analog input signal into a digital signal and sends it to a processor 52.” Borotto: [0097] "This electrical performance variation is processed by a set of micro-controllers in order to calculate the load position and the relative intensity. The force applied to each sensor is computed independently.").
Regarding claim 13, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 9, wherein the controller is configured to execute: a first correction process to correct the first measurement value, and a second correction process to correct the second measurement value, with the second correction process being different from the first correction process (Borotto: [0097] "This electrical performance variation is processed by a set of micro-controllers in order to calculate the load position and the relative intensity. The force applied to each sensor is computed independently.” Sarvazyan: [0088] “The possibility that some sensors could produce an erroneous signal, as well as that some rows and column in the sensor array could have incorrect tuning or calibrating are taken into account. Such column and row errors may cause false pressure jumps or gaps in the pressure data. For each interior row or column of the sensor array, the detection algorithm calculates a pressure signal value relative to the linear interpolation based on the boundary pressure.” [0090] “each subsequent pressure response data frame carrying the prostate pressure response data is analyzed in blocks 90 and 94 for placing new pressure response information into the two-dimensional composite prostate image. Block 90 runs a matching algorithm trying to find best fit of a current prostate pressure response image inside the two-dimensional composite prostate image;” [0097] “Since orientation tracking system of the present invention provides only orientation angles including azimuth angle 113, it is important to use the shaft pressure sensor array to detect the position of the sphincter center and use it as a reference point to calculate the movements of the probe head. Initial position of the probe is assigned the azimuth angle value of zero as corresponding to the first pressing of the probe head against the prostate. Knowing the distance between the sphincter center as detected by the shaft sensor array and the current azimuth angle 113, the new coordinate of the probe head can be calculated from that distance by multiplying it by sinus of the azimuth angle value”).
Regarding claim 14, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 13, wherein the first correction process is configured to compensate for a deviation between the first measurement value and an actual pressure applied on the first pressure sensor (Borotto: [0097] "This electrical performance variation is processed by a set of micro-controllers in order to calculate the load position and the relative intensity. The force applied to each sensor is computed independently." Sarvazyan: [0088] “The possibility that some sensors could produce an erroneous signal, as well as that some rows and column in the sensor array could have incorrect tuning or calibrating are taken into account. Such column and row errors may cause false pressure jumps or gaps in the pressure data. For each interior row or column of the sensor array, the detection algorithm calculates a pressure signal value relative to the linear interpolation based on the boundary pressure.” [0098] “two different three-dimensional mechanical prostate images are constructed: one image includes only normalized pressure response pixels (each pixel value of the prostate mechanical image is divided by a modified average of analyzed pressure response data frame), while another image includes only absolute pressure response pixels.”).
Regarding claim 15, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 14, wherein the deviation is based on a shape of a multilayer product that includes a pressure dispersion plate and a first elastic body (Borotto: [0097] "This electrical performance variation is processed by a set of micro-controllers in order to calculate the load position and the relative intensity. The force applied to each sensor is computed independently." [0103] “Depending on the applications, a rigid plate, made of plastic or metal, can be encapsulated in contact with the external gold pads to stiffen the capacitor armatures while keeping stretchable the connections to the sensor.” Fig. 13. Sarvazyan: [0067] “each pressure sensor includes a capacitive pressure transducer covered by an elastic compound.” [0088] “The possibility that some sensors could produce an erroneous signal, as well as that some rows and column in the sensor array could have incorrect tuning or calibrating are taken into account. Such column and row errors may cause false pressure jumps or gaps in the pressure data. For each interior row or column of the sensor array, the detection algorithm calculates a pressure signal value relative to the linear interpolation based on the boundary pressure.”).
Regarding claim 16, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 14, wherein the deviation is based a distance of the first pressure sensor to the handle (Borotto: [0097] "This electrical performance variation is processed by a set of micro-controllers in order to calculate the load position and the relative intensity. The force applied to each sensor is computed independently.” Sarvazyan: Fig. 2; [0097] “Since orientation tracking system of the present invention provides only orientation angles including azimuth angle 113, it is important to use the shaft pressure sensor array to detect the position of the sphincter center and use it as a reference point to calculate the movements of the probe head. Initial position of the probe is assigned the azimuth angle value of zero as corresponding to the first pressing of the probe head against the prostate. Knowing the distance between the sphincter center as detected by the shaft sensor array and the current azimuth angle 113, the new coordinate of the probe head can be calculated from that distance by multiplying it by sinus of the azimuth angle value”).
Regarding claim 17, Sarvazyan teaches the oral pressure measurement device according to Claim 14, wherein the first correction process compensates for the deviation based on a correction map by multiplying the first measurement value by a coefficient determined according to the correction map (Borotto: [0097] "This electrical performance variation is processed by a set of micro-controllers in order to calculate the load position and the relative intensity. The force applied to each sensor is computed independently." Sarvazyan: [0088] “The possibility that some sensors could produce an erroneous signal, as well as that some rows and column in the sensor array could have incorrect tuning or calibrating are taken into account. Such column and row errors may cause false pressure jumps or gaps in the pressure data. For each interior row or column of the sensor array, the detection algorithm calculates a pressure signal value relative to the linear interpolation based on the boundary pressure.”).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarvazyan (US 20080221484 A1) in view of Borotto (US 20170265978 A1), and in further view of Gonzales (US 20200197785 A1).
Regarding claim 10, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 9. However, the combination of Sarvazyan/Borotto discloses fails to disclose comparing each of the measurement values to a threshold and only outputting the values that reach at least the threshold level.
Gonzales teaches a mouth guard that senses impact forces and determines if the forces exceed an impact threshold. Gonzales discloses wherein the controller is configured to compare each of the first measurement value and the second measurement value to a predetermined threshold, and wherein, if either one of the first measurement value and the second measurement value is more than or equal to the threshold, and the other of the first measurement value and the second measurement value is less than the threshold, the controller is configured to outputs only the respective measurement value that is more than or equal to the threshold as a measurement result ([0018] “wherein, in response to at least one of the linear sensor and the rotational sensor detecting a force above a predetermined force threshold, the processor activates the notification component to produce a feedback to be sensed by the user.” Fig. 8; [0081] “the display 52 may include impact data 56, such as acceleration and force (linear and/or rotational). Further, a risk calculation 58 may be displayed. The risk calculation may be determined either locally or remotely, and is based predetermined impact thresholds unique to each user based on his or her biometric information.”).
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 combination of Sarvazyan/Borotto to include comparing each of the measurement values to a threshold and only outputting the values that reach at least the threshold level as disclosed in Gonzales to notify a user of an excessive impact force (Gonzales [0018]).
Regarding claim 11, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 9, further comprising an alarm (Sarvazyan: Claim 18, “an alarm means indicating excessive compression force, said alarm means triggered when said shaft pressure response data exceeds a predetermined level of sphincter pressure force.”). However, the combination of Sarvazyan/Borotto fails to particularly discloses a sound, vibration, or light alarm.
Gonzales discloses, configured to generate a notification as one or more of a sound, a vibration, and a light ([0061] “the processor 28 receives the data from the rotational and/or linear force sensing units and determines whether the predetermined threshold has been exceeded. If so, the processor 28 then communicates with the notification component 36 to begin activation that results in the haptic feedback, a vibratory feedback (e.g., a buzzer), or auditory feedback” [0055] “An LED driver 9 controls the actuation of an LED 10 on the front side 4 of the PCBA 2. The LED 10 is used to indicate to others (e.g., other players, a coach, a referee) that the user has experienced a certain concussion-risk event (or events when considering a series of impact forces over a period of time).”).
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 combination of Sarvazyan/Borotto to include an alarm as disclosed in Gonzales to notify users of excessive impact forces (Gonzales [0060]).
Regarding claim 12, the combination of Sarvazyan/Gonzales discloses the oral pressure measurement device according to Claim 11, wherein the controller is configured to generate the alarm if both the first measurement value and the second measurement value are more than or equal to a predetermined threshold (Sarvazyan: head pressure sensor array 1, shaft pressure sensor array 2; Claim 18, “alarm means indicating excessive compression force;” Gonzales: [0061] “the processor 28 receives the data from the rotational and/or linear force sensing units and determines whether the predetermined threshold has been exceeded. If so, the processor 28 then communicates with the notification component 36 to begin activation that results in the haptic feedback, a vibratory feedback (e.g., a buzzer), or auditory feedback.”).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarvazyan (US 20080221484 A1) in view of Borotto (US 20170265978 A1), and in further view of Severson (US 3943915 A).
Regarding claim 18, the combination of Sarvazyan/Borotto discloses the oral pressure measurement device according to Claim 1, wherein each of the first and second pressure sensors includes a pair of plate members (Sarvazyan: [0067] “each pressure sensor includes a capacitive pressure transducer covered by an elastic compound.” Borotto: Fig. 13, Cr+Au metal plates). However, the combination of Sarvazyan/Borotto fails to explicitly disclose resin.
Severson teaches a pressure sensor for use internal to the human body. Severson discloses and a resin member disposed therebetween (Fig. 1, capacitor plates 24 and 32, spacer 31; Col 2, lines 55-69 “the spacer 31 is constituted by a 0.005 inch thick polyimide material which is secured to the undersurface of member 24 and to the upper surface of member 32 by means of a suitable insulative adhesive, such as an epoxy film adhesive.”).
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 system of Sarvazyan to include epoxy resin between the plates as disclosed in Severson to serve as a suitable insulative adhesive for the functioning of the capacitors (Severson Col 2, lines 55-69).
Regarding claim 19, the combination of Sarvazyan/Borotto/Severson discloses the oral pressure measurement device according to Claim 18, wherein each of the first and second pressure sensors is configured to measure pressure based on a change in electrostatic capacity between the respective pair of plate members (Sarvazyan: [0067] “each pressure sensor includes a capacitive pressure transducer covered by an elastic compound.” Borotto: [0061] “The sensor of the invention generally comprises two main components, namely a capacitive pad appointed to the detection of the pressure signal(s) upon dental occlusion/clenching, and a transmission conductive line that electrically transmits the detected signal to a micro-controller unit.” [0097] “The force applied to each sensor is computed independently.” Fig. 13. Severson: Fig. 1, capacitor plates 24 and 32).
Conclusion
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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