DETAILED ACTION
Claims 1-20 are hereby under examination.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/12/2023 is being considered by the examiner.
Claim Objections
Claims 1, 3-4, 7, 10, 12-13, 15, 17, and 20 are objected to because of the following informalities:
Regarding claim 1, line 3 recites “a user’s”, however it appears it should read --said user’s-- (emphasis added).
Regarding claim 1, line 6 recites “said integrated sensor”, however it appears it should read --said at least one integrated sensor-- (emphasis added).
Regarding claim 1, line 10 recites “said integrated sensor”, however it appears it should read --said at least one integrated sensor-- (emphasis added).
Regarding claim 3, line 2 recites “a user’s”, however it appears it should read --said user’s-- (emphasis added).
Regarding claim 4, line 3 recites “a user’s”, however it appears it should read --said user’s-- (emphasis added).
Regarding claim 7, line 2 recites “said inner wall”, however it appears it should read --an inner wall-- (emphasis added) to ensure proper antecedent basis.
Regarding claim 10, line 3 recites “a user’s”, however it appears it should read --said user’s-- (emphasis added).
Regarding claim 12, line 1 recites “said integrated sensor”, however it appears it should read --said at least one integrated sensor-- (emphasis added).
Regarding claim 13, line 1 recites “said integrated sensor”, however it appears it should read --said at least one integrated sensor-- (emphasis added).
Regarding claim 15, line 2 recites “a user’s”, however it appears it should read --said user’s-- (emphasis added).
Regarding claim 17, line 2 recites “a user’s”, however it appears it should read --said user’s-- (emphasis added).
Regarding claim 17, line 3 recites “a user’s”, however it appears it should read --said user’s-- (emphasis added).
Regarding claim 17, line 10 recites “said integrated sensor”, however it appears it should read --said at least one integrated sensor-- (emphasis added).
Regarding claim 20, line 3 recites “a user’s”, however it appears it should read --said user’s-- (emphasis added).
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.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Demarest et al. (US 20180229032 A1), hereinafter referred to as Demarest, in view of Herman et al. (US 20130066236 A1), hereinafter referred to as Herman.
The claims are generally directed towards a teeth cleaning system for monitoring analytes in saliva comprising: a handle assembly that is connected to a tray that is configured to be inserted into a user’s mouth to surround a user’s upper and lower teeth; said tray comprising at least one aperture that is configured to house at least one integrated sensor; said integrated sensor that is configured to identify a concentration of an analyte in said user’s saliva; and a transmitter that is configured to transmit a signal that represents said concentration of said analyte in said user’s saliva to an external processor; wherein said integrated sensor is configured to be inserted and removed from said aperture by said user.
Regarding claim 1, Demarest discloses a teeth cleaning system for monitoring analytes in saliva (Abstract, “oral care device”, Fig. 2, para. [0016], “include a sensor …”) comprising:
a tray that is configured to be inserted into a user’s mouth to surround a user’s upper and lower teeth (Fig. 2, element 200, para. [0056], “oral care device … support structure shaped as a mouthpiece including a base for positioning the upper and lower teeth and a sidewall extending from the base for positioning along the sides of the teeth …”);
said tray comprising at least one aperture that is configured to house at least one integrated sensor (Fig. 2, element 218, para. [0060], “one or more sensors also are included on the device …”);
said integrated sensor that is configured to identify a concentration of an analyte in said user’s saliva (para. [0060], “sensors may sense one or more of … a pH level of the oral cavity … targeted bacteria within the oral cavity, saliva markers, gas phase markers …”); and
a transmitter that is configured to transmit a signal that represents said concentration of said analyte in said user’s saliva to an external processor (para. [0060], “information about sensed data may be transmitted to an external device, e.g., a smart phone or other computing device …”).
However, Demarest does not explicitly disclose a handle assembly is connected to the tray.
Herman teaches of an analogous mouthguard apparatus (Abstract, Fig. 1, Fig. 2). Herman further teaches the apparatus includes a handle assembly that is connected to a tray that is configured to be inserted into a user’s mouth to surround a user’s upper and lower teeth (Fig. 1, element 58, element 50, para. [0053-0054], para. [0056-0058]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tray disclosed by Demarest to additionally include a handle assembly that is connected to the tray, as taught by Demarest. This is because Herman teaches a handle assembly allows for an electronics package to be removable connected to the dental appliance, and allows for the electronics package to be housed outside of the users mouth (para. [0056-0057]), allowing for the dental appliance to be sterilized separately, and allowing for the dental appliance to be smaller.
However, modified Demarest does not explicitly disclose wherein said integrated sensor is configured to be inserted and removed from said aperture by said user.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the integrated sensor to explicitly be configured to be inserted and removed from said aperture by said user (MPEP 2144.4, V, A, In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose."). One of ordinary skill in the art would have recognized an integrated sensor that is configured to be inserted and removed from said aperture by said user allows for single use sensors to be used, reducing the cost of the device.
Regarding claim 2, modified Demarest discloses the teeth cleaning system of claim 1, wherein said teeth cleaning system further comprises said transmitter for transmitting data related to a first concentration and a second concentration to an external network (para. [0060], “one or more sensors … sense one or more of a pH level … targeted bacteria … saliva markers, gas phase markers … information about the sensed data may be transmitted to an external device, e.g., a smart phone or other computing device …”).
Regarding claim 3, modified Demarest discloses the teeth cleaning system of claim 2, wherein said external network is configured to be in communications with an app of a user’s mobile device (para. [0060], “transmitted to an external device, e.g., a smart phone or other computing device … on-board microcontroller may be provided to process the sensor data … functionality may be done by a remote device, such as a smartphone … user may program a dispensing pattern into an application accessible via a computing device …”).
Regarding claim 4, modified Demarest discloses the teeth cleaning system of claim 1, wherein said teeth cleaning system further comprises a receiver for receiving data related to recommendations for said user in response to said concentration from an app of a user’s mobile device (para. [0060], “Data from sensors may be collected for subsequent review … information about the sensed data may be transmitted … sensors indicate that conditions in the mouth, e.g., pH or humidity, are conductive to bacterial growth, one or both therapeutic elements may be controlled to selectively administer an antibacterial agent … on-board microcontroller … microcontroller or an external device may be used to control administration of the therapeutic agent. For example, a user may program a dispensing pattern into an application accessible via a computing device …”).
Regarding claim 5, modified Demarest discloses the teeth cleaning system of claim 1, wherein at least one electrochemical analyzer is configured to analyze said signal from said at least one integrated sensor (para. [0060], “on-board microcontroller may be provided to process the sensor data …”).
Regarding claim 6, modified Demarest discloses the teeth cleaning system of claim 5.
However, modified Demarest does not explicitly disclose wherein said electrochemical analyzer is configured to be housed in said handle assembly.
Herman further teaches the handle assembly includes an electronics package (Fig. 1, element 50, para. [0056-0057], para. [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle assembly taught by modified Demarest to explicitly house the electrochemical analyzer in the handle assembly, as taught by Herman. This is because Herman teaches an electrochemical analyzer in a handle assembly allows for the electronics to be housed outside of the users mouth (para. [0056-0057]), allowing for the dental appliance to be sterilized separately, and allowing for the dental appliance to be smaller.
Regarding claim 7, modified Demarest discloses the teeth cleaning system of claim 1, wherein said at least one integrated sensor is adjacent to said inner wall of said tray, wherein said inner wall of said tray is configured to collect said user’s saliva (Fig. 2, element 218, para. [0056], “outside sidewall … inner sidewall …”, para. [0060-0061], “one or more sensors also are included on the device … sense one or more of … targeted bacteria within the oral cavity … saliva markers … stimulate saliva production …”).
Regarding claim 8, modified Demarest discloses the teeth cleaning system of claim 7, wherein said at least one integrated sensor further comprises at least two integrated sensors (Fig. 2, element 218, para. [0060], “one or more sensors … any number of intraoral sensors for sensing one or more conditions of the oral cavity … a pH level of the oral cavity … targeted bacteria within the oral cavity, saliva markers, gas phase markers …”).
However, modified Demarest does not explicitly disclose that the at least two integrated sensors are adjacent to opposite sides of said inner wall of said tray.
As to locations of the at least two integrated sensors, Demarest teaches one or more sensors are included on the device (para. [0060]). The locations of the at least two integrated sensors will depend upon the usable space of the device and what the at least two integrated sensors are measuring. As such, the locations of the at least two integrated sensors are results-effective variables that would have been optimized through routine experimentation based on the dimensions of the device and the choice of the intraoral sensors. It would have been obvious to one of ordinary skill in the art at the time of invention to select the locations of the at least two integrated sensors so as to be adjacent to opposite sides of said inner wall of said tray.
Regarding claim 9, modified Demarest discloses the teeth cleaning system of claim 1, wherein said teeth cleaning system further comprises at least a second integrated sensor that is configured to identify a second concentration of a second analyte in said user’s saliva (Fig. 2, element 218, para. [0060], “one or more sensors … any number of intraoral sensors for sensing one or more conditions of the oral cavity … a pH level of the oral cavity … targeted bacteria within the oral cavity, saliva markers, gas phase markers …”).
Regarding claim 10, Demarest discloses a system for cleaning teeth (Abstract, “oral care device”, Fig. 2, para. [0016], “include a sensor …”) comprising:
a tray that is configured to be inserted into a user’s mouth to surround a user’s upper and lower teeth (Fig. 2, element 200, para. [0056], “oral care device … support structure shaped as a mouthpiece including a base for positioning the upper and lower teeth and a sidewall extending from the base for positioning along the sides of the teeth …”);
said tray comprising at least one integrated sensor that is configured to identify a concentration of an analyte in said user’s saliva (Fig. 2, element 218, para. [0060], “one or more sensors also are included on the device … sensors may sense one or more of … a pH level of the oral cavity … targeted bacteria within the oral cavity, saliva markers, gas phase markers …”);
an electrochemical analyzer that is connected to said at least one integrated sensor, wherein said electrochemical analyzer is configured to transmit a first signal representing said concentration to a processor (para. [0060], “sense one or more of … targeted bacteria within the oral cavity, saliva markers, gas phase markers … data from the sensors may be collected for subsequent review and diagnosis, for example, in an on-board memory … on-board microcontroller may be provided to process the sensor data …”); and
a transmitter that is configured to transmit a second signal received from said processor that represents said concentration to an external network (para. [0060], “information about the sensed data mya be transmitted to an external device, e.g., a smart phone or other computing device …”).
However, Demarest does not explicitly disclose a handle assembly that is connected to the tray.
Herman teaches of an analogous mouthguard apparatus (Abstract, Fig. 1, Fig. 2). Herman further teaches the apparatus includes a handle assembly that is connected to a tray that is configured to be inserted into a user’s mouth to surround a user’s upper and lower teeth (Fig. 1, element 58, element 50, para. [0053-0054], para. [0056-0058]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tray disclosed by Demarest to additionally include a handle assembly that is connected to the tray, as taught by Demarest. This is because Herman teaches a handle assembly allows for an electronics package to be removable connected to the dental appliance, and allows for the electronics package to be housed outside of the users mouth (para. [0056-0057]), allowing for the dental appliance to be sterilized separately, and allowing for the dental appliance to be smaller.
Regarding claim 11, modified Demarest discloses the teeth cleaning system of claim 10, wherein said external network is connected to an app on a mobile device of said user (para. [0060], “transmitted to an external device, e.g., a smart phone or other computing device … on-board microcontroller may be provided to process the sensor data … functionality may be done by a remote device, such as a smartphone … user may program a dispensing pattern into an application accessible via a computing device …”).
Regarding claim 12, modified Demarest discloses the teeth cleaning system of claim 10, wherein said integrated sensor is adjacent to an inner wall of said tray, wherein said inner wall of said tray is configured to collect said user’s saliva (Fig. 2, element 218, para. [0056], “outside sidewall … inner sidewall …”, para. [0060-0061], “one or more sensors also are included on the device … sense one or more of … targeted bacteria within the oral cavity … saliva markers … stimulate saliva production …”).
Regarding claim 13, modified Demarest discloses the teeth cleaning system of claim 12, wherein said integrated sensor further comprises at least two integrated sensors (Fig. 2, element 218, para. [0060], “one or more sensors … any number of intraoral sensors for sensing one or more conditions of the oral cavity … a pH level of the oral cavity … targeted bacteria within the oral cavity, saliva markers, gas phase markers …”).
However, modified Demarest does not explicitly disclose that the two at least two integrated sensors are adjacent to opposite sides of said inner wall of said tray.
As to locations of the at least two integrated sensors, Demarest teaches one or more sensors are included on the device (para. [0060]). The locations of the at least two integrated sensors will depend upon the usable space of the device and what the at least two integrated sensors are measuring. As such, the locations of the at least two integrated sensors are results-effective variables that would have been optimized through routine experimentation based on the dimensions of the device and the choice of the intraoral sensors. It would have been obvious to one of ordinary skill in the art at the time of invention to select the locations of the at least two integrated sensors so as to be adjacent to opposite sides of said inner wall of said tray.
Regarding claim 14, modified Demarest discloses the teeth cleaning system of claim 13, wherein said system for cleaning teeth further comprises at least a second integrated sensor that is configured to identify a second concentration of a second analyte in said user’s saliva (Fig. 2, element 218, para. [0060], “one or more sensors … any number of intraoral sensors for sensing one or more conditions of the oral cavity … a pH level of the oral cavity … targeted bacteria within the oral cavity, saliva markers, gas phase markers …”).
Regarding claim 15, modified Demarest discloses the teeth cleaning system of claim 10, wherein said external network is configured to be in communication with an app of a user’s mobile device (para. [0060], “transmitted to an external device, e.g., a smart phone or other computing device … on-board microcontroller may be provided to process the sensor data … functionality may be done by a remote device, such as a smartphone … user may program a dispensing pattern into an application accessible via a computing device …”).
Regarding claim 16, modified Demarest discloses the teeth cleaning system of claim 10.
However, modified Demarest does not explicitly disclose wherein said electrochemical analyzer is configured to be housed in said handle assembly.
Herman further teaches the handle assembly includes an electronics package (Fig. 1, element 50, para. [0056-0057], para. [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle assembly taught by modified Demarest to explicitly house the electrochemical analyzer in the handle assembly, as taught by Herman. This is because Herman teaches an electrochemical analyzer in a handle assembly allows for the electronics to be housed outside of the users mouth (para. [0056-0057]), allowing for the dental appliance to be sterilized separately, and allowing for the dental appliance to be smaller.
Regarding claim 17, Demarest discloses a teeth cleaning system for analyzing analytes in a user’s saliva (Abstract, “oral care device”, Fig. 2, para. [0016], “include a sensor …”, para. [0060]) comprising:
a tray that is configured to be inserted into a user’s mouth to surround a user’s upper and lower teeth (Fig. 2, element 200, para. [0056], “oral care device … support structure shaped as a mouthpiece including a base for positioning the upper and lower teeth and a sidewall extending from the base for positioning along the sides of the teeth …”);
said tray comprising at least one integrated sensor that is configured to identify a concentration of an analyte in said user’s saliva (Fig. 2, element 218, para. [0060], “one or more sensors also are included on the device … sensors may sense one or more of … a pH level of the oral cavity … targeted bacteria within the oral cavity, saliva markers, gas phase markers …”);
a processor that is configured to receive a first signal related to said concentration of said analyte in said user’s saliva (para. [0060], “data from the sensors may be collected for subsequent review and diagnosis, for example, in an on-board memory … on-board microcontroller may be provided to process the sensor data …”); and
a transmitter that is configured to transmit a second signal from said processor related to said concentration of said analyte in said user’s saliva to an external network (para. [0060], “information about the sensed data may be transmitted to an external device, e.g., a smart phone or other computing device …”);
wherein said integrated sensor is adjacent to an inner wall of said tray (Fig. 2, element 218, para. [0056], “outside sidewall … inner sidewall …”, para. [0060-0061], “one or more sensors also are included on the device”).
However, Demarest does not explicitly disclose a handle assembly that is connected to the tray and said processor is housed in said handle assembly.
Herman teaches of an analogous mouthguard apparatus (Abstract, Fig. 1, Fig. 2). Herman further teaches the apparatus includes a handle assembly that is connected to a tray that is configured to be inserted into a user’s mouth to surround a user’s upper and lower teeth (Fig. 1, element 58, element 50, para. [0053-0054], para. [0056-0058]). Herman further teaches the handle assembly includes an electronics package (Fig. 1, element 50, para. [0056-0057], para. [0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tray disclosed by Demarest to additionally include a handle assembly that is connected to the tray, and explicitly house the electrochemical analyzer in the handle assembly, as taught by Demarest. This is because Herman teaches a handle assembly allows for an electronics package to be removable connected to the dental appliance, and allows for the electronics package to be housed outside of the users mouth (para. [0056-0057]), allowing for the dental appliance to be sterilized separately, and allowing for the dental appliance to be smaller.
Regarding claim 18, modified Demarest discloses the teeth cleaning system of Claim 17, wherein at least one integrated sensor further comprises at least two integrated sensors (Fig. 2, element 218, para. [0060], “one or more sensors … any number of intraoral sensors for sensing one or more conditions of the oral cavity … a pH level of the oral cavity … targeted bacteria within the oral cavity, saliva markers, gas phase markers …”).
However, modified Demarest does not explicitly disclose that the at least two integrated sensors are adjacent to opposite sides of said inner wall of said tray.
As to locations of the at least two integrated sensors, Demarest teaches one or more sensors are included on the device (para. [0060]). The locations of the at least two integrated sensors will depend upon the usable space of the device and what the at least two integrated sensors are measuring. As such, the locations of the at least two integrated sensors are results-effective variables that would have been optimized through routine experimentation based on the dimensions of the device and the choice of the intraoral sensors. It would have been obvious to one of ordinary skill in the art at the time of invention to select the locations of the at least two integrated sensors so as to be adjacent to opposite sides of said inner wall of said tray.
Regarding claim 19, modified Demarest discloses the teeth cleaning system of claim 17, wherein said external network is connected to an app on a mobile device of said user (para. [0060], “transmitted to an external device, e.g., a smart phone or other computing device … on-board microcontroller may be provided to process the sensor data … functionality may be done by a remote device, such as a smartphone … user may program a dispensing pattern into an application accessible via a computing device …”).
Regarding claim 20, modified Demarest discloses the teeth cleaning system of claim 17, said teeth cleaning system further comprises a receiver for receiving data related to recommendations for said user in response to said concentration from an app of a user’s mobile device (para. [0060], “Data from sensors may be collected for subsequent review … information about the sensed data may be transmitted … sensors indicate that conditions in the mouth, e.g., pH or humidity, are conductive to bacterial growth, one or both therapeutic elements may be controlled to selectively administer an antibacterial agent … on-board microcontroller … microcontroller or an external device may be used to control administration of the therapeutic agent. For example, a user may program a dispensing pattern into an application accessible via a computing device …”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Igor Reizenson (US 20190183619 A1) - discloses an oral hygiene system (Fig. 2) comprising a handle assembly that is connected to a tray that is configured to be inserted into a user’s mouth to surround a user’s upper and lower teeth (Fig. 2, Fig. 4, para. [0021], para. [0027]) and includes an integrated sensor configured to identify a concentration of an analyte in said user’s saliva (para. [0049]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791