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.
Claims 1-10,23,25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kopelman 20160199215 in view of Shah et al 20170312117 and Hill et al 6542774.
As an initial matter, it is noted that the claimed subject matter was not disclosed in either of the prior filed applications to which applicant claims priority. Thus, the Kopelman reference qualifies as prior art under 35 U.S.C. 103.
With regard to claims 1,5,7 Kopelman discloses a dual-purpose orthodontic appliance engageable with a patient's upper or lower teeth (see figs 2A-3C); comprising a control module 504 configured with wireless communication protocols, the control module mounted on a bite retainer having a tooth tray 14 of the orthodontic appliance; at least one sensor mounted on the tooth tray (see paragraph 67 which discloses that the processor (control module) 504 may be wired to the sensor, and paragraph 76 which discloses that sensors may be mounted on the appliance), the at least one sensor in wired or wireless communication (paragraph 68) with the control module 504; the dual-purpose orthodontic appliance, including the control module 504 and the at least one sensor, to straighten teeth of the patient (the appliance can be an aligner, which straightens teeth, see paragraph 43) while treating one of a sleep apnea condition or a snoring condition.
Kopelman does not disclose an electrode mounted on the tray for providing an electric shock to stimulate only the tongue or only in proximity of a hypoglossal nerve, the control module applying an electrical stimulation via the electrode.
Shah et al disclose wherein electrical stimulation can be provided by an electrode mounted on a tray (see claim 16 of Shah et al which discloses that the device includes electrodes). Shah et al also disclose that it is known to use a device to provide stimulation to the hypoglossal nerve for purposes of treating sleep apnea.
It would have been obvious to one skilled in the art to include an electrode mounted on the tray of Kopelman, with the control module of Kopelman applying electrical stimulation only in proximity of the hypoglossal nerve via the electrode, in view of the teaching of Shah et al that it is known to provide stimulation to a hypoglossal nerve to treat sleep apnea, as well as the teaching of Kopelman
that an intraoral tray mounted electrode can be used to provide stimulation to treat a condition in the oral cavity. One skilled in the art would recognize that an electrode that stimulates the area in proximity of the hypoglossal nerve, could be positioned so that it stimulates only the hypoglossal nerve.
Kopelman/Shah et al do not disclose the appliance applying the stimulation with a pulsed current.
Hill et al disclose a method of stimulating the hypoglossal nerve, in which a pulsed current is used to stimulate the nerve. See col. 9, lines 38-65.
It would have been obvious to one skilled in the art to utilize a pulsed current with the appliance of Kopelman/Shah et al, in view of the teaching of Hill et al that a pulsed current may be used to apply electrical stimulation to the hypoglossal nerve.
With regard to claim 2, note that the at least one sensor measures a body temperature, a respiration rate, or a heart rate, a vibration in a respiration of the patient, an airflow rate, an oxygen concentration, a carbon dioxide concentration, an atmospheric pressure, an intraoral air pressure, a noise, or a pressure exerted on a mandibular advancement device (MAD) of the dual-purpose orthodontic appliance. See paragraph 60 of Kopelman.
With regard to claim 23, Kopelman discloses that the device may be manufactured by additive technology. See paragraph 42.
With regard to claims 3,4,10 Kopelman does not disclose air passageways surrounding teeth trays of the appliance, with micro holes in the passageways to stimulate a tongue of the patient with an airflow, nor an air passageway extending outside a mouth of the patient, with the air passageway connecting to the tooth tray.
Shah et al disclose an intraoral device which utilizes air passageways 115 (fig. 1D) that surround teeth trays of the device, the passageways 115 having micro holes (fig. 16) to stimulate the tongue with an airflow for reducing sleep apnea. Shah et al also disclose an air passageway 13 (see fig. 1B) that extends outside the mouth of a patient.
It would have been obvious to one skilled in the art to include air passageways with micro holes that provide an airflow to the tongue, as well as an air passageway that extends outside of the mouth, with the device of Kopelman/Shah et al/Hill et al, in view of the teaching of Shah et al that such air passageways/micro holes may be combined with an intraoral tray type appliance, for treating sleep apnea.
With further regard to claim 3, note that the mandibular advancement device 16/18 of Kopelman is adjusted in real time by the at least one sensor and control module, based on changes in the patient to provide an effective mandible position.
With regard to claim 8, Kopelman does not disclose control module providing an airflow to the tongue.
Shah et al discloses that the control module may provide airflow (paragraph 11).
It would have been obvious to one skilled in the art to modify the control module of Kopelman/Shah et al/Hill et al to provide airflow through the air passageways, in view of the teaching of Shah et al that a controller may be used to provide airflow through air passageways in an intraoral mouthpiece.
With regard to claim 9, this claim appears to recite a method step of applying electrical stimulation. The leads claimed are only being claimed functionally. Thus, it is clear that the device of Kopelman/Shah et al/Hill et al is capable of providing electrical stimulation via leads under the tongue, if one wished to do so via leads attached to the device.
With regard to claim 6, Kopelman/Shah et al/Hill et al discloses a machine learning module (the processor may utilize machine learning, see paragraphs 21 and 22 of Kopelman, among others).
Kopelman/Shah et al/Hill et al do not disclose the machine learning module separate from the control module, mounted on the tooth tray to learn a pattern of tongue retraction and apply the electric current.
It would have been obvious to one skilled to include a machine learning module mounted on the tooth tray of Kopelman/Shah et al/Hill et al to learn a pattern of tongue retraction as well as apply an electric current, in view of the teaching of Kopelman that machine learning may be used to detect sleep apnea events (such as tongue retraction) (see paragraph 22), as well as the teaching of Shah et al that an electric current maybe applied to the tongue to assist intreating sleep apnea.
With regard to claim 25, although Kopelman discloses that a plurality of sensors may be provided (paragraphs 23 and 24), and also discloses that the sensors may measure a compliance (this is inherent, as any sensor measurement would be indicative of the device being worn by a patient, as opposed to not being worn), as well as position of the patient (paragraph 73), Kopelman does not disclose a sensor capable of detecting an apnea-hypopnea index.
Shah et al disclose an intraoral device that utilizes sensors to detect certain physiological characteristics. Shah et al also discloses that the sensors may be used to detect an apnea -hypopnea index (AHI). See paragraph 38.
It would have been obvious to one skilled in the art to modify the device of Kopelman/Shah et al/Hill et al such that the sensors can detect an apnea-hypopnea index, in view of the teaching of Shah et al that an intraoral device utilizing sensors may be used to detect an apnea -hypopnea index.
With regard to claim 27, note that a wire is inherent in the use of the electrode connected to the teeth tray as disclosed by Shah et al. See paragraph 174 which discloses that wired technology may be used for the appliance. An electrode in the vicinity of the hypoglossal nerve (which is disclosed by Kopelman/Shah et al) would inherently be bonded to the tray at a location that is not in contact with the teeth, due to the location of the hypoglossal nerve.
With regard to claim 28, note that the entirety of the appliance of Kopelman is entirely within the oral cavity when in use. Thus, no portion of the appliance of Kopelman/Shah et al/Hill et al is external to the patient’s mouth when in use.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Kopelman 20160199215 in view of Shah et al 20170312117 and Hill et al 6542774, and further in view of Zegarelli 20170347956.
With regard to claim 26, Kopelman/Shah et al/Hill et al do not disclose the electrode bonded to the tray, the electrode coated with an FDA approved adhesive.
Zegarelli discloses an intraoral tray 200 (fig. 6A) which may have an electrode 204 mounted thereto. Zegarelli discloses that the electrode may be attached to the tray via an adhesive (a coating of the adhesive on the electrode is inherent).
It would have been obvious to one skilled in the art to bond the electrode to the tray in the appliance of Kopelman/Shah et al/Hill et al with a coating of an adhesive, as taught by Zegarelli, in view of the teaching of Zegarelli that an electrode may be attached to an intraoral tray with a coating of an adhesive. It also would have been obvious to one skilled in the art to utilize a FDA approved adhesive, since the tray is used intraorally.
Response to Arguments
Applicant's arguments filed 11/5/25 have been fully considered but they are not persuasive.
Applicant argues (page 12 of response) that the Kopelman reference discloses in paragraph 0004 that a desired feature of the device is to provide “decreased undesirable side effects, such as tooth repositioning”. Applicant also argues that (page 13 of response) the disclosure in paragraph 0043 of Kopelman does not teach that the recited “aligner” is for tooth straightening, but rather to disclose the material and form of the shells.
This is not found persuasive. While it is clear that Kopelman is concerned with tooth movement, the key word in the disclosure is “undesirable”. Taking this into consideration, the paragraph 43 disclosure of Kopelman clearly discloses that the shells can be “aligners” which are devices used to create desirable tooth movement. The disclosure in paragraph 43 clearly contemplates that the aligner shells may be used to initiate orthodontic repositioning, which is not “undesirable”. Therefore, applicant’s argument that there would be no motivation to modify the device of Kopelman such that the device would move teeth while treating sleep apnea or snoring, would destroy the intended function of the Kopelman device is not found persuasive. As a side note, the office action did not allege that it would be obvious to modify Kopelman to provide a dual function device…Kopelman already discloses such an embodiment (paragraph 43).
Conclusion
THIS ACTION IS MADE FINAL. 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 NICHOLAS D LUCCHESI whose telephone number is (571)272-4977. The examiner can normally be reached M-F 800-430.
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/NICHOLAS D LUCCHESI/Primary Examiner, Art Unit 3772