DETAILED ACTION
The amendment filed on 12/23/25 has been received and considered. By this amendment, claims 1, 8, 15, 18-19 and 33 are amended. Claims 48-49 are added and claim 7 is cancelled.
Response to Arguments
Applicant's arguments filed 12/23/25 have been fully considered but they are not persuasive. With regard to the anterior portion, Shanta does disclose cap 104 is positioned sublingually as described in par. 87 (“enclosure 104 which covers the free tip and its undersurface of the tongue”). Fig. 8 also shows that a portion of the cap is angled inwards to hold the tongue so the part that is under the tongue is sublingual.
Applicant’s arguments, see pages 9-12, filed 12/23/25, with respect to the rejection(s) of claim(s) 1 under 35 USC 102(a)(1) and the rejection of claim 18 under 35 USC 103 have been fully considered and are persuasive with regard to the lateral portions not providing a sublingual platform. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Makower et al. (PG Pub. 2014/0090654).
Shantha still reads on claim 33 as it does not require the sublingual platform created by the anterior and lateral portions. Furthermore, Shantha’s device does not teach away from sublingual portions because cap 104 is sublingual and therefore, does not teach away from a reasonable combination with Lattner or Makower.
Claim Objections
Claim 12 is objected to because of the following informalities: “shaped” should be “shape”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
In view of the amendments to claims 15 and 19, the previous 112 rejection is withdrawn.
Claim Rejections - 35 USC § 102
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) 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shantha (PG Pub. 2011/0155143).
PNG
media_image1.png
368
478
media_image1.png
Greyscale
Regarding Claim 33, Shantha discloses a method for treating obstructive sleep apne, comprising: providing an intraoral device (see device 101) comprising anterior (see cap 104) and lateral portions (see skirt 136) defining an open space between the lateral portions (see modified Fig. 5 below); introducing the device into a subject’s oral cavity such that a base of a tongue of the subject is received in the open space (see Fig. 8), the anterior portion of the device is positioned sublingually adjacent front teeth of the subject (see par. 87 and Fig. 10), and a posterior portion (see plate 135) of the device is positioned adjacent the pharyngeal airway of the subject (see par. 94 and Fig. 8); and activating the device such that one or more sensors monitor one or more parameters of the subject during sleep and, when one or more conditions are met, the device delivers stimulation to the tongue to prevent or treat sleep apnea (see par. 59, 108, and 121).
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, 5, 8-10, 12, 48 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha (PG Pub. 2011/0155143) in view of Makower et al. (PG Pub. 2014/0090654).
Regarding Claim 1, Shantha discloses a device for treating obstructive sleep apnea, comprising: a body (see device 101) comprising an anterior portion (see cap 104), a posterior portion (see plate 135), and a pair of lateral portions extending between the anterior and posterior portions (see skirt 136) shaped for introduction into a subject's oral cavity to position the anterior portion adjacent front teeth of the subject and the posterior portion adjacent the pharyngeal airway of the subject (see Fig. 8); and one or more sensors or stimulators on the body (see par. 59). Shantha discloses the anterior portion is shaped to provide a sublingual platform (see par. 87), but does not disclose the lateral portions offer the same. Makower discloses a similar apnea treatment oral device (see par. 6) wherein the anterior (see region 206; Fig. 2A) and lateral portions (see side regions 210, 212; par. 48) are shaped to provide a sublingual platform (see Fig. 2B) defining an open space between the lateral portions configured to receive a base of a tongue of the subject with the anterior portion positioned sublingually (see Fig. 3A, par. 50). It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate the lateral portions providing a sublingual platform because Makower teaches it provides more points of contact and fuller tongue engagement for retaining the tongue in the forward position (see par. 6 and 13).
Regarding Claim 5, Shantha discloses a retention component on the anterior portion configured to engage one or more of the front teeth to prevent migration of the body (see teeth socket pockets 106-107; par. 90; Fig. 6).
Regarding Claim 8, Shantha discloses wherein the one or more sensors or stimulators comprise one or more stimulators (see stimulator 119), but does not disclose the stimulators are on upper surfaces of one or both of the anterior and lateral portions. Makower discloses stimulators on upper surfaces of the anterior and lateral portions (see par. 99 and Fig. 49). It would have been obvious to one of ordinary skill in the art at the time of the invention to place the stimulators on the oral device because Makower teaches it allows providing stimulation directly to the tongue (see par. 99).
Regarding Claim 9, Shantha discloses wherein the one or more stimulators are configured to generate, but not limited to, one or more of electrical current, chemical, aroma, release, vibration, or sound (see par. 95).
Regarding Claim 10, Shantha discloses wherein the one or more stimulators are configured to activate neuromuscular contraction, stimulate salivation and subsequent swallowing movement, or induce partial wakefulness of the subject (see par. 59).
Regarding Claim 12, Shantha discloses the posterior portion comprises a retroglossal pad or tail shaped to support a posterior region of the subject’s tongue (see bulging 128; par. 85 and Fig. 4).
Regarding Claims 48 and 49, Shantha does not explicitly show the shape of the space formed by the anterior and lateral portions (see Fig. 5). Makower discloses wherein the sublingual platform is shaped such that the open space defines a key hole shaped space including a larger posterior region and a narrower anterior region configured to provide room for the subject’s lingual frenum and allow for anterior projection and lateral movements of the tongue tip (see Fig. 2B and par. 51). Makower also discloses wherein the upper surfaces of the anterior portions have a gentle concave slope down towards the subject’s lingual frenum to accommodate natural convexity of a ventral surface of the tongue (see Fig. 3B, 38). It would have been obvious to one of ordinary skill in the art at the time of the invention to shape the oral device to match the anatomy of the tongue to engage as much of the user’s tongue as possible (see par. 49) without any discomfort (see par. 100).
Claim(s) 6, 11, and 13-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha (PG Pub. 2011/0155143) in view of Makower et al. (PG Pub. 2014/0090654) as applied to Claim 1 above, and further in view of Lattner et al. (PG Pub. 2003/0069626).
Regarding Claim 6, Shantha does not disclose one or more stops on the lateral portions. Lattner discloses a similar intraoral apnea device with a pair of lateral portions (see arms 64 and 66) comprising one or more stops (see attaching members 88 and 90) on the lateral portions for contacting one or more teeth to provide vertical support for the body (see par. 42 and Fig. 1). It would have been obvious to one of ordinary skill in the art at the time of the invention to include supports on the lateral portions because Lattner teaches it helps maintain electrodes in a substantially fixed position relative to the lower teeth (see par. 42).
Regarding Claim 11, Lattner discloses wherein the one or more sensors or stimulators comprise one or more pressure sensors on the anterior portion and/or lateral portions (see par. 72 and 82; Fig. 3). It would have been obvious to one of ordinary skill in the art at the time of the invention to include a pressure sensor because Lattner teaches it is useful in detecting the breathing disorder (see par. 72).
Regarding Claim 13, Lattner discloses wherein the one or more sensors or stimulators comprise a sensor configured to detect changes, but not limited to, in one or more of sound, acoustic wave, vibration, air pressure, airflow velocity, contact stress, textile, contact, gravity, volume, temperature, humidity, pressure stress, movement of anatomic structures, strain, and/or deformation (see temperature; par. 47 and 78). Lattner does not explicitly disclose the sensor is on the posterior portion of the device. It would have been obvious to one of ordinary skill in the art at the time of the invention to place the sensor on the posterior portion of Shantha’s device since it has been held that rearranging parts of an invention involves only routine skill in the art (In re Japikse, 86 USPQ 70).
Regarding Claim 14, Lattner discloses wherein the one or more sensors or stimulators comprise one or more stimulators (see electrode groups 34 and 42; par. 31) on the anterior portion and/or lateral portions (see Fig. 3), and wherein the device further comprises:
an extraoral device configured for placement on the subject’s neck, nose, chest, abdomen, or face outside the oral cavity or that remains completely detached from body parts, the extraoral device comprising one or more sensors (see belt sensor; par. 84). It would have been obvious to one of ordinary skill in the art at the time of the invention to include an extraoral device because Lattner teaches the belt is a design choice and will work equally as well to provide information about respiration (see par. 84).
Regarding Claims 15 and 19, Lattner discloses wherein the extraoral device comprises one or more wireless sound sensors configured to be placed in proximity to the subject (see “acoustically based”; par. 47). It would have been obvious to one of ordinary skill in the art at the time of the invention to use wireless sound sensors because Lattner teaches they can indicate a patient’s respiratory state (see par. 47).
Regarding Claims 16 and 20, Lattner discloses wherein the extraoral device is configured to communicate wirelessly with the device introduced into the subject’s oral cavity (see par. 84-85). It would have been obvious to one of ordinary skill in the art at the time of the invention to have a wireless communication between the extraoral device and the intraoral device because Lattner teaches the benefit of remote control and the advantage of no wires passing into the patient’s mouth (see par. 85).
Regarding Claim 17, Lattner discloses further comprising a processor (see control unit 50) on the body coupled to the one or more stimulators (see par. 31), the processor configured to receive signals from the extraoral device and, when the processor identifies an event of airway obstruction, the processor activates the one or more stimulators (see par. 52, 78 and 93). It would have been obvious to one of ordinary skill in the art at the time of the invention to activate stimulation in response to the extraoral device to minimize blockage (see par. 9 and 35).
Regarding Claim 18, see rejections of claims 1 and 17 above.
Regarding Claim 21, see rejection of claim 9 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shah (US Patent 12458527) discloses various oral devices with sublingual extensions (see Fig. 6).
Scarberry et al. (PG Pub. 2001/0047805) discloses a palate engaging element with a tongue retaining sleeve (see par. 55) for apnea treatment.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 NATASHA PATEL whose telephone number is (571)272-5818. The examiner can normally be reached 9-5 M-F Eastern.
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, Unsu Jung can be reached at (571) 272-8506. 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.
/N.P/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792