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 § 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.
Claims 4, 20, 43, and 45-46 are 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.
Regarding claim 4, the limitation “optionally wherein the first state of adjustment is a non-protrusive state where the upper jaw and lower jaw are in their natural relaxed relative positions, and the second state of adjustment is a protrusive state where the upper jaw and lower jaw are in positions displaced from their natural relative positions.” renders the claims indefinite because limitations following “optionally” may or may not be required. Therefore, the metes and bounds of the claim are indefinite. For the purposes of Examination, any limitation following “optionally” will not be considered required.
Regarding claim 20, “optionally wherein the mold is scanned to provide a 3-D digital image which is used to manufacture a custom oral appliance, wherein the 3-D digital image is provided as an STL file or a 3D file format, and wherein the 3-D scan of the mold is optionally obtained using a CT scanner or a cone beam CT (CBCT) scanner.” renders the claims indefinite because limitations following “optionally” may or may not be required. Therefore, the metes and bounds of the claim are indefinite. For the purposes of Examination, any limitation following “optionally” will not be considered required.
Regarding claim 43, the limitation “optionally measured using one or more biosensors, provided in a wearable smart device selected from a smart watch, a chest strap, a head strap, a fingertip monitor, and/or in the oral appliance.” renders the claims indefinite because limitations following “optionally” may or may not be required. Therefore, the metes and bounds of the claim are indefinite. For the purposes of Examination, any limitation following “optionally” will not be considered required.
Regarding claim 45, the limitation “optionally wherein the custom oral appliance comprises one or more biosensors, wherein the custom oral appliance is configured to measure one or more sleep parameters while the patient is sleeping with the custom oral appliance.” renders the claims indefinite because limitations following “optionally” may or may not be required. Therefore, the metes and bounds of the claim are indefinite. For the purposes of Examination, any limitation following “optionally” will not be considered required.
Regarding claim 46, the limitation “optionally wherein the custom oral appliance comprises one or more biosensors, wherein the custom oral appliance is configured to measure one or more sleep parameters while the patient is sleeping with the custom oral appliance.” renders the claims indefinite because limitations following “optionally” may or may not be required. Therefore, the metes and bounds of the claim are indefinite. For the purposes of Examination, any limitation following “optionally” will not be considered required.
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.
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, 4, 13-18, 20, 24-25, 41, 43, 45-46, 49, and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (U.S. Patent Application Publication No. 2014/0190490) hereinafter referred to as Walker; in view of Morgan (U.S. Patent No. 9,999,488) hereinafter referred to as Morgan; in view of Shah et al. (U.S. Patent Application Publication No. 2018/0116863) hereinafter referred to as Shah.
Regarding claim 1, Walker teaches a system for diagnosing and treating obstructive sleep apnea (OSA) in a patient (¶[0057]), the system comprising:
an oral appliance (¶[0057] element 13 oral appliance), wherein the oral appliance comprises:
a lower mandibular portion adapted for fitting engagement with a lower dentition of the patient (Fig. 4, element 2 lower-tray, ¶[0076] engages dentition), wherein the mandibular portion is configured to cover only a portion of the backmost molar of the lower dentition of the patient (Fig. 3-4, the rear-most face of the device is open, providing a rear surface of the backmost tooth in a mouth that is not covered);
an upper maxillary portion adapted for fitting engagement with an upper dentition of the patient (Fig. 4, element 1 upper-tray, ¶[0076] engages dentition), wherein the maxillary portion is configured to cover only a portion of the backmost molar of the upper dentition of the patient (Fig. 3-4, the rear-most face of the device is open, providing a rear surface of the backmost tooth in a mouth that is not covered); and
a connection system configured to connect the upper maxillary portion and the lower mandibular portion to limit the range of movement of the maxillary portion relative to the mandibular portion, wherein the connection system comprises:
at least one connecting strap configured for attachment at a first end to the upper maxillary portion and at a second end to the lower mandibular portion (Figs. 3-4, element 9),
wherein the at least one connecting strap is attached to the upper maxillary portion and the lower mandibular portion via retainer pins located on an outer side of the upper maxillary portion and on an outer side of the lower mandibular portion (Figs. 3-4 elements 11).
Walker does not teach wherein the connecting straps are formed with slots configured to facilitate movement between the mandibular portion and the maxillary portion, and wherein each said slot comprises an enlarged opening in the middle configured to securely and removably receive a respective retainer pin to facilitate ease of removal of the connecting strap from the retainer pin.
While Walker does teach biosensors in a separate embodiment, in the embodiment of Fig. 4, Walker further does not teach one or more biosensors configured to measure the one or more sleep parameters; and a sleep application configured to monitor the one or more sleep parameters of the patient during sleep, wherein the application is configured to conduct one or more of a level 1, level 2, level 3 or level 4 sleep study; wherein the system is configured to: measure one or more sleep parameters while the patient is sleeping in a first sleep condition to obtain a first set of sleep parameters; and measure one or more sleep parameters while the patient is sleeping in a second sleep condition to obtain a second set of sleep parameters; compare the first and second sets of sleep parameters to quantify a change in sleep quality/patterns resulting from wearing the oral appliance; and correlate the change in sleep quality/patterns with a diagnosis of OSA in the patient and a determination of the effectiveness of oral appliance therapy for treating the OSA.
Attention is drawn to the Morgan reference, which teaches wherein the connecting straps are formed with slots (Fig. 12, element 52 slot) configured to facilitate movement between the mandibular portion and the maxillary portion (this is an intended use, and particularly as no particular frame of reference for “movement between” is claimed, given limited patentable weight as it appears that the movement between portions is dependent on how the device is used), and wherein each said slot comprises an enlarged opening in the middle configured to securely and removably receive a respective retainer pin to facilitate ease of removal of the connecting strap from the retainer pin (Fig. 12, element 40 pin, col. 6, lines 1-10, col. 7, lines 43-end, the slots and tab are formed so as to cooperate with each other and a T-shaped cross-sections includes at least one section that is enlarged as an opening compared to other sections).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connecting straps of Walker to include slots and enlarged openings, as taught by Morgan, because the sizes and shapes of the tabs and slots of Morgan can be standardized to provide flexibility for additional devices (Morgan, col. 7, lines 36-42).
Walker as modified does not teach one or more biosensors configured to measure the one or more sleep parameters; and a sleep application configured to monitor the one or more sleep parameters of the patient during sleep, wherein the application is configured to conduct one or more of a level 1, level 2, level 3 or level 4 sleep study; wherein the system is configured to: measure one or more sleep parameters while the patient is sleeping in a first sleep condition to obtain a first set of sleep parameters; and measure one or more sleep parameters while the patient is sleeping in a second sleep condition to obtain a second set of sleep parameters; compare the first and second sets of sleep parameters to quantify a change in sleep quality/patterns resulting from wearing the oral appliance; and correlate the change in sleep quality/patterns with a diagnosis of OSA in the patient and a determination of the effectiveness of oral appliance therapy for treating the OSA.
Attention is drawn to the Shah reference, which teaches a mandibular advancement device (¶[0093]) one or more biosensors configured to measure one or more sleep parameters (¶[0090], ¶[0199]); and a sleep application configured to monitor the one or more sleep parameters of the patient during sleep (¶¶[0114-0115]), wherein the application is configured to conduct one or more of a level 1, level 2, level 3 or level 4 sleep study (¶[0116] home sleep study, which corresponds to at least levels 3 and 4, ¶[0052]); wherein the system is configured to: measure one or more sleep parameters while the patient is sleeping in a first sleep condition (¶[0116] different mandibular advancement positions) to obtain a first set of sleep parameters (¶[0174]); and measure one or more sleep parameters while the patient is sleeping in a second sleep condition (¶[0116] different mandibular advancement positions) to obtain a second set of sleep parameters (¶[0174]); compare the first and second sets of sleep parameters to quantify a change in sleep quality/patterns resulting from wearing the oral appliance (¶[0116], ¶¶[0174-0175]); and correlate the change in sleep quality/patterns with a diagnosis of OSA (¶¶[0174-0175]) in the patient and a determination of the effectiveness of oral appliance therapy for treating the OSA (¶[0116] titration of the device is adjusting the device over time until effective treatment is achieved, ¶[0175]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the oral appliance of Walker as modified to include biosensors and a sleep application as taught by Shah, to provide feedback on sleep quality/AHI index, and compliance (Shah ¶[0100]).
Regarding claim 4, Walker as modified teaches the system of claim 1.
Shah further teaches wherein the first sleep condition comprises sleeping with the oral appliance in a first state of adjustment, and the second sleep condition comprises sleeping with the oral appliance in a second state of adjustment (¶[0116] different mandibular advancement positions).
Regarding claim 13, Walker as modified teaches the system of claim 1.
Walker further teaches wherein the portion of the backmost molar of the upper dentition is the outer portion, and the portion of the backmost molar of the lower dentition is the inner portion (Fig. 4, the covered portions of the backmost molars are the outer and inner surfaces, compared to the backmost posterior surface).
Regarding claim 14, Walker as modified teaches the system of claim 1.
Walker further teaches wherein the portion of the backmost molar of the upper dentition is the inner portion, and the portion of the backmost molar of the lower dentition is the outer portion (Fig. 4, the covered portions of the backmost molars are the outer and inner surfaces, compared to the backmost posterior surface).
Regarding claim 15, Walker as modified teaches the system of claim 1.
Shah further teaches wherein the system is configured to measure one or more sleep parameters while the patient is sleeping in multiple different sleep conditions (¶[0116] different mandibular advancement positions).
Regarding claim 16, Walker as modified teaches the system of claim 1.
Shah further teaches wherein the one or more sleep parameters are selected from heart rate, breathing rate, head movement, body movement, body temperature, actigraphy, oximetry, apnea hypopnea index (AHI), cardiac data, respiratory air flow, sleeping position, patient compliance and snoring (¶[0038], ¶[0042], ¶[0100], ¶[0148], ¶[0199]).
Regarding claim 17, Walker as modified teaches the system of claim 1.
Shah further teaches wherein the sleep application is a mobile application configured to interface with a smart device configured to measure the one or more sleep parameters using one or more biosensors (¶[0038], ¶[0152]).
Regarding claim 18, Walker as modified teaches the system of claim 17.
Shah further teaches wherein the smart device is a wearable smart device selected from a fingertip monitor, and/or the oral appliance (¶[0109], ¶[0113]).
Regarding claim 20, Walker as modified teaches the system of claim 1.
Walker does not teach a kit for preparation of a mold of the patient's teeth.
However Walker does teach a drawback to non-custom oral appliances (¶[0013]).
Attention is drawn to the Shah reference, which teaches custom-formed oral appliances using casting (¶[0012], ¶[0045]), including a kit for preparation of a mold of the patient’s teeth (¶[0097] creating an impression of the teeth).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Walker as modified to include taking an impression of a user’s teeth for a custom-formed appliance, as taught by Shah, because Walker teaches that custom appliances are superior (Walker ¶[0013]) and Shah teaches that custom devices provide better fit and more comfort (Shah ¶[0096]).
Regarding claim 24, Walker as modified teaches the system of claim 1.
Walker as modified does not teach a tele-health platform configured to provide an interface with a health care professional, whereby the health care professional can monitor the one or more sleep parameters using the tele-health platform.
Shah further teaches comprising a tele-health platform configured to provide an interface with a health care professional, whereby the health care professional can monitor the one or more sleep parameters using the tele-health platform (¶[0152]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the oral appliance of Walker as modified to include a tele-health platform, as taught by Shah, because it allows a doctor to monitor the sleeping parameters over time (Shah ¶[0119], ¶[0152]).
Regarding claims 25, 43, and 45, the claim is directed to a process comprising substantially the same subject matter as claims 1, 16, and 20 and are rejected under substantially the same portions of Walker, Morgan, and Shah.
Regarding claim 41, Walker as modified teaches the process of claim 25.
Shah further teaches wherein the determination of the effectiveness of OAT for treating the OSA includes a determination of the effectiveness of a provisional oral appliance for treatment of the OSA with OAT (¶[0116]).
Regarding claim 46, Walker teaches the process of claim 25.
Walker as modified does not teach wherein upon a positive diagnosis of OSA in the patient and a determination of the effectiveness of OAT, the process further comprises: obtaining a 3-D digital scan of the patient's teeth, and using the 3-D digital scan to manufacture a custom oral appliance.
However Walker does teach a drawback to non-custom oral appliances (¶[0013]).
Shah further teaches wherein upon a positive diagnosis of OSA in the patient and a determination of the effectiveness of OAT, the process further comprises: obtaining a 3-D digital scan of the patient's teeth, and using the 3-D digital scan to manufacture a custom oral appliance (¶[0097]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Walker as modified to include 3-D scanning and manufacturing of a custom oral appliance, as taught by Shah, because Walker teaches that custom appliances are superior (Walker ¶[0013]) and Shah teaches that 3D printing has advantageous design freedom (Shah ¶[0097]).
Regarding claims 49 and 57, the claim is directed to an apparatus comprising substantially the same subject matter as claim 16 and is rejected under substantially the same sections of Walker, Morgan, and Shah.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker, Morgan, and Shah as applied to claim 17 above, and further in view of Phillips et al. (U.S. Patent Application Publication No. 2014/0088373) hereinafter referred to as Phillips.
Regarding claim 19, Walker as modified teaches the system of claim 17.
Walker as modified does not teach wherein the smart device is a non-wearable smart device located in proximity to the sleeping patient.
Attention is brought to the Phillips reference, which teaches a smart device for monitoring a sleeping user (Fig. 1, element 100), wherein the smart device is a non-wearable smart device located in proximity to the sleeping patient (¶[0051]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Walker as modified to include non-contact sensors, as taught by Phillips, because Phillips teaches that sensors requiring contact are a drawback that the invention of Phillips overcomes with the improvement of simplified non-contact sensing (Phillips ¶[0020]).
Conclusion
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/AMANDA L STEINBERG/Examiner, Art Unit 3792