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 § 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) 1-2, 4, 7-11, 13-15, 17-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Pat Pub No. 20170347956 to Zegarelli.
Regarding claim 1. Zegarelli discloses an intraoral system (para 0004, 0014, etc.), comprising: a polymeric shell appliance comprising a plurality of cavities for receiving a patient’s teeth (para 0007, 0046, 0064, 0065, etc., fig 1), wherein the polymeric shell appliance is configured to be removably worn over the patient’s teeth (para 0036, 0090 “oral appliance can be removed”); and a sensor assembly coupled to the polymeric shell appliance (para 0043, 0136, 0137, 0146, etc. “data collection device 302 (e.g., sensor)”), the sensor assembly comprising a power source (para 0150 “power supply 306”), a sensor that is configured to detect air flow during inhalation and/or exhalation of the patient when the patient is wearing the polymeric shell appliance (para 0146 “the sensor can be placed in the air flow of the oral cavity and measure the user's respiration rate,”), a memory for storing air flow data based on the detected air flow (para 0072, 0112, 0159 etc. “memory”), and wireless circuity for transmitting information associated with the air flow data to an external device (para 0157, fig 11).
Regarding claim 2. Zegarelli discloses the intraoral system of claim 1, wherein the sensor assembly comprises one or more processors configured to determine, based on the air flow data, a respiration rate of the patient (para 0146 “measure the user's respiration rate”).
Regarding claim 3. The intraoral system of claim 1, wherein the sensor assembly comprises one or more processors configured to determine, based on the air flow data, whether the patient is snoring or has sleep apnea during sleep (para 0043 “the data collection device 302 (e.g., sensor) can measure oxygen or carbon dioxide content in the oral cavity to monitor conditions such as, for example, sleep apnea,”).
Regarding claim 4. Zegarelli discloses the intraoral system of claim 1, wherein the polymeric shell appliance is shaped to resiliently reposition the patient’s teeth according to a phase of an orthodontic treatment plan (para 0005 “the oral appliance is a custom fit oral appliance”; fig. 8; it is understood that custom fitting the oral appliance could be according to any phase/plan as desired by anyone, including an orthodontic).
Regarding claim 7. Zegarelli discloses the intraoral system of claim 1, wherein the sensor assembly is configured to analyze air inhaled by the patient (para 0146).
Regarding claim 8. Zegarelli discloses the intraoral system of claim 7, wherein the sensor assembly is configured to analyze toxic or harmful substances in the inhaled air and warn the patient of the toxic or harmful substances (para 0043 “the data collection device 302 (e.g., sensor) can measure [] carbon dioxide content in the oral cavity”).
Regarding claim 9. Zegarelli discloses the intraoral system of claim 1, wherein the sensor assembly is configured to analyze air exhaled by the patient to detect volatile and/or non-volatile compounds (para 0078 “one or more sensors and/or hydrogel to detect volatile sulfur compounds”).
Regarding claim 10. Zegarelli discloses the intraoral system of claim 1, wherein the sensor assembly is configured to analyze air exhaled by the patient to detect an alcohol level (para 0147 “alcohol breathalyzers”).
Regarding claim 11. Zegarelli discloses the intraoral system of claim 1, wherein the sensor assembly is configured to analyze air exhaled by the patient to detect one or more markers for bad breath (para 0078, 0081 “halitosis”; para 0142).
Regarding claim 13. Zegarelli discloses a method (para 0004, 0014, etc.), comprising: placing a polymeric shell appliance over a patient’s teeth such that the patient’s teeth are positioned within a plurality of cavities of the polymeric shell appliance (para 0007, 0046, 0064, 0065, etc., fig 1), wherein the polymeric shell appliance is configured to be removable from the patient’s teeth (para 0036, 0090 “oral appliance can be removed”); detecting air flow during inhalation and/or exhalation of a patient (para 0146 “the sensor can be placed in the air flow of the oral cavity and measure the user's respiration rate,”), wherein the air flow is detected by a sensor of a sensor assembly coupled with the polymeric shell appliance worn by the patient (para 0043, 0136, 0137, 0146, etc. “data collection device 302 (e.g., sensor)”), wherein the sensor assembly is powered by a power source coupled with the polymeric shell appliance (para 0150 “power supply 306”); storing air flow data based on the detected air flow in a memory of the sensory assembly (para 0072, 0112, 0159 etc. “memory”); and transmitting information associated with the air flow data to an external device via wireless circuitry of the sensor assembly (para 0157, fig 11).
Regarding claim 14. Zegarelli discloses the method of claim 13, wherein the sensor assembly determines a respiration rate of the patient (para 0146 “measure the user's respiration rate”).
Regarding claim 15. Zegarelli discloses the method of claim 13, wherein the sensor assembly detects whether the patient is snoring or has sleep apnea during sleep (para 0043 “the data collection device 302 (e.g., sensor) can measure oxygen or carbon dioxide content in the oral cavity to monitor conditions such as, for example, sleep apnea,”).
Regarding claim 17. Zegarelli discloses the method of claim 13, wherein the sensor assembly analyzes air inhaled by the patient (para 0146).
Regarding claim 18. Zegarelli discloses an intraoral system (para 0004, 0014, etc.), comprising: a polymeric shell appliance comprising a plurality of cavities for receiving a patient’s teeth (para 0007, 0046, 0064, 0065, etc., fig 1), wherein the polymeric shell appliance is configured to be removably worn over the patient’s teeth (para 0036, 0090 “oral appliance can be removed”); and a sensor assembly coupled to the polymeric shell appliance (para 0043, 0136, 0137, 0146, etc. “data collection device 302 (e.g., sensor)”), the sensor assembly comprising a power source (para 0150 “power supply 306”), a sensor that is configured to detect air flow during inhalation and/or exhalation of the patient when the patient is wearing the polymeric shell appliance (para 0146 “the sensor can be placed in the air flow of the oral cavity and measure the user's respiration rate,”), a memory for storing air flow data based on the detected air flow (para 0072, 0112, 0159 etc. “memory”), and wireless circuity for transmitting information associated with the air flow data to an external device (para 0157, fig 11), wherein the sensor assembly is configured to detect whether the patient is snoring or has sleep apnea during sleep (para 0043 “the data collection device 302 (e.g., sensor) can measure oxygen or carbon dioxide content in the oral cavity to monitor conditions such as, for example, sleep apnea,”).
Regarding claim 19. Zegarelli discloses the intraoral system of claim 18, wherein the polymeric shell appliance is shaped to resiliently reposition the patient’s teeth according to a phase of an orthodontic treatment plan (para 0005 “the oral appliance is a custom fit oral appliance”; fig. 8; it is understood that custom fitting the oral appliance could be according to any phase/plan as desired by anyone, including an orthodontic).
Regarding claim 20. Zegarelli discloses the intraoral system of claim 18, wherein the sensor assembly comprises one or more processors configured to determine, based on the air flow data, a respiration rate of the patient (para 0146 “measure the user's respiration rate”).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20170347956 to Zegarelli.
Regarding claim 12. Zegarelli discloses the intraoral system of claim 1, wherein the sensor assembly includes microfluidic components associated with analyzing chemical content of air exhaled by the patient and/or air inhaled by the patient (para 0081, 0136 “detect chemical”). It is understood that since Zegarelli discloses detecting chemical components, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include known microfluidic components to perform the chemical detection for analysis.
Claim(s) 5-6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20170347956 to Zegarelli in view of US Pat Pub No 20170319129 to Shah et al. (hereinafter “Shah”)
Regarding claim 5. Zegarelli discloses the intraoral system of claim 1, but fails to disclose wherein the sensor assembly is configured to activate the patient’s muscles in response to determining snoring or sleep apnea to encourage or cause the patient’s airways to open.
Shah, from a similar field of endeavor shows that it is known for the oral appliance to have electrical stimulation capability for providing mild shocks to the soft palates and tongue in order to alleviate the blockage of airway passage from persisting further due to above events (para 0165). 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 disclosure of Zegarelli with the known teachings of Shah to provide the predictable result of alleviating the blockage of airway passage.
Regarding claim 6. Zegarelli as modified by Shah renders obvious the intraoral system of claim 3, wherein the sensor assembly is configured to deliver electrical stimulation to the patient in response to detecting the snoring or sleep apnea to encourage or cause the patient’s airways to open (Shah, para 0165).
Regarding claim 16. Zegarelli discloses the method of claim 15, but fails to disclose further comprising delivering electrical stimulation to the patient in response to detecting the snoring or sleep apnea to encourage or cause the patient’s airways to open.
Shah, from a similar field of endeavor shows that it is known for the oral appliance to have electrical stimulation capability for providing mild shocks to the soft palates and tongue in order to alleviate the blockage of airway passage from persisting further due to above events (para 0165). 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 disclosure of Zegarelli with the known teachings of Shah to provide the predictable result of alleviating the blockage of airway passage.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. 20160199215 to Kopelman; US 20090281433 to Saadat et al.; US 20180085059 A1 to Lee; EP2489306B1 to Melker et al; US 20120172678 to Logan et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer S McDonald can be reached at (571) 270- 3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SANA SAHAND/Examiner, Art Unit 3796
Prosecution Insights