DETAILED ACTION
This action is in response to the Response to Election/Restriction filed 5/19/2026. Currently, claims 1-20 are pending in the application.
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 .
Election/Restrictions
Applicant’s election without traverse of Species I, Figures 1A-1I (corresponding to claims 1-20) in the reply filed on 5/19/2026 is acknowledged.
Claim Objections
Claim 10 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “size of mouth” in line 2 of the claim should be amended to recite ---size of a mouth---. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “in position with relative to” in line 2 of the claim should be amended to recite ---in position relative to---. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “space for tongue” in line 2 of the claim should be amended to recite ---space for a tongue---. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “a first piece” in line 9 of the claim should be amended to recite ---the first piece---. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “a second piece” in line 10 of the claim should be amended to recite ---the second piece---. Appropriate correction is required.
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.
Claim 4 is 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 term "silicon-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "-like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 7 is 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. Claim 7 recites “a thickness and curvature of the film is adjusted to require different levels of pressure to move between the first position and the second position, wherein the different levels of pressure help tighten soft tissues in a mouth of the user to open airway.” This is an active, method step claim limitation, making it unclear what statutory category Applicant is attempting to claim (since claim 7 is drawn to an apparatus). For purposes of examination, the examiner will interpret this claim limitation to mean ---a curvature of the film is adjustable---.
Claim 19 is 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. Claim 19 recites “wherein controlled airflow helps reduce snoring.” This is an active, method step claim limitation, making it unclear what statutory category Applicant is attempting to claim (since claim 19 is drawn to an apparatus).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 limitation “wherein controlled airflow helps reduce snoring” does not further limit the subject matter of claim 1 (from which claim 19 depends). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-5, 8, 10-15 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Togliatti (US 2018/0243124 A1).
Regarding claim 1, Togliatti teaches in Figures 5(a) and 5(b) a first piece (maxillary component 501) configured to engage upper teeth of a user ([0073] teaches “maxillary component 501 includes a maxillary receptacle (receptacle 505) for receiving the maxillary teeth of a user”), the first piece (maxillary component 501) having a first end (forward, anterior end of maxillary component 501) and a second end (rearward, posterior end of maxillary component 501); a second piece (mandibular component 502) configured to engage lower teeth of the user ([0075] teaches “mandibular component 502 is adapted to receive a user's mandibular teeth”), the second piece (mandibular component 502) attached to (as shown in Figures 5(a) and 5(b); [0076] teaches “maxillary component 501 and mandibular component 502 of the mandibular advancement mouthpiece form an acute angle Φ with its vertex at a posterior region of the mandibular advancement mouthpiece 555”) the second end (rearward, posterior end of maxillary component 501) of the first piece (maxillary component 501); and a film (tongue sleeve 503) coupled between (as shown in Figures 5(a) and 5(b); [0071] teaches “tongue sleeve 503 may be situated between maxillary component 501 and mandibular component 502”) the first piece (maxillary component 501) and the second piece (mandibular component 502), the film (tongue sleeve 503) configured to control airflow through (inasmuch as the tongue sleeve 503 is shown in Figures 5(a) and 5(b) to be a physical barrier that can block airflow through mouthpiece 555) the mouthpiece (mouthpiece 555).
Regarding claim 2, Togliatti teaches the apparatus of claim 1. Togliatti teaches in Figures 5(a) and 5(b) that the film (tongue sleeve 503) is configured to cover a gap between (as shown in Figures 5(a) and 5(b)) the first piece (maxillary component 501) and the second piece (mandibular component 502).
Regarding claim 3, Togliatti teaches the apparatus of claim 1. Togliatti teaches in [0013] and [0082] that the first piece (maxillary component 501), the second piece (mandibular component 502), and the film (tongue sleeve 503) are manufactured from same type of material ([0013] teaches “the tongue sleeve may have the material makeup, by way of a non-limiting example, of a surgical or medical-grade polymer;” [0082] teaches maxillary component 501 and mandibular component 502 being made of “rigid plastics;” thus, maxillary component 501, mandibular component 502 and tongue sleeve 503 are all made of polymer materials).
Regarding claim 4, Togliatti teaches the apparatus of claims 1 and 3. Togliatti teaches in [0013] and [0082] that the material is silicone-like material ([0013] teaches “the tongue sleeve may have the material makeup, by way of a non-limiting example, of a surgical or medical-grade polymer;” [0082] teaches maxillary component 501 and mandibular component 502 being made of “rigid plastics;” thus, maxillary component 501, mandibular component 502 and tongue sleeve 503 are all made of polymer materials; silicone is also a polymer and therefore, the material can be considered “like” silicone).
Regarding claim 5, Togliatti teaches the apparatus of claims 1 and 3. Togliatti teaches in Figures 5(a) and 5(b) and [0072] that the first piece (maxillary component 501), the second piece (mandibular component 502), and the film (tongue sleeve 503) are structured as a single piece (Figures 5(a) and 5(b) teaches the maxillary component 501, mandibular component 502 and tongue sleeve 503 being connected to form a single unit; [0072] teaches “tongue sleeve 503 is integral with mouthpiece 555”).
Claim 5 limitation “molded” is a product-by-process claim limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Regarding claim 8, Togliatti teaches the apparatus of claim 1. Togliatti teaches in Figures 5(a) and 5(b) that the film (tongue sleeve 503) does not include any holes (Figures 5(a) and 5(b) teaches that the tongue sleeve 503 is configured without any holes therethrough) to block the airflow through (inasmuch as the tongue sleeve 503 is shown in Figures 5(a) and 5(b) to be a physical barrier that can block airflow through mouthpiece 555) the mouthpiece (mouthpiece 555).
Regarding claim 10, Togliatti teaches the apparatus of claim 1. Togliatti teaches in [0013] that the film (tongue sleeve 503) is further configured to stretch to adjust to size of mouth of the user ([0013] teaches that “the tongue sleeve is made of a flexible material;” therefore, the tongue sleeve 503 is capable of flexing to extend, or stretch, toward a planar configuration as needed when the user’s mouth opens).
Regarding claim 11, Togliatti teaches the apparatus of claim 1. Togliatti teaches in [0072] that the film (tongue sleeve 503) is further configured to help keep the first piece (maxillary component 501) and the second piece (mandibular component 502) in position with relative to the upper teeth and the lower teeth of the user ([0072] teaches tongue sleeve 503 functioning “for securely receiving a tip portion of a user's tongue;” since the tongue sleeve 503 secures the mouthpiece 555 to the user’s tongue, it also functions to secure the attached maxillary component 501 and mandibular component 502 in position as well).
Regarding claim 12, Togliatti teaches the apparatus of claim 1. Togliatti teaches in Figures 5(a) and 5(b) and [0072] that the film (tongue sleeve 503) includes a curvature configured to provide space for tongue of the user (as shown in Figures 5(a) and 5(b); [0072] teaches “tongue sleeve 503 may include a somewhat spherical or semi-spherical portion, comprising a concaved cavity, or interior surface 512, for securely receiving a tip portion of a user's tongue”).
Regarding claim 13, Togliatti teaches the apparatus of claims 1 and 12. Togliatti teaches in Figures 5(a) and 5(b) that the curvature is further configured to permit the film (tongue sleeve 503) to be folded between (Figures 5(a) and 5(b) teach the tongue sleeve 503 being bent over itself between maxillary component 501 and mandibular component 502; [0013] teaches that “the tongue sleeve is made of a flexible material,” which would enable the tongue sleeve 503 to be flexed for folding) the first piece (maxillary component 501) and the second piece (mandibular component 502).
Regarding claim 14, Togliatti teaches the apparatus of claim 1. Togliatti teaches in Figures 5(a) and 5(b) a handle (inner surface 522; can be considered a “handle” inasmuch as it is capable of being manually grasped) attached to (as shown in Figures 5(a) and 5(b)) the film (tongue sleeve 503), the handle (inner surface 522) configured to permit the user to move the mouthpiece (mouthpiece 555) relative to a mouth of the user (inner surface 522 is capable of being manually grasped by a user to move the mouthpiece 555 relative to the user’s mouth).
Regarding claim 15, Togliatti teaches the apparatus of claim 1. Togliatti teaches in Figure 5(a) that the first piece (maxillary component 501) and the second piece (mandibular component 502) include extruded (protruding) surfaces (as defined in the annotated copy of Figure 5(a) provided below) on surfaces coupled to (as shown in Figure 5(a)) the film (tongue sleeve 503).
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Regarding claim 17, Togliatti teaches the apparatus of claim 1. Togliatti teaches in Figures 5(a) and 5(b) that the film (tongue sleeve 503) is configured to block the airflow through (inasmuch as the tongue sleeve 503 is shown in Figures 5(a) and 5(b) to be a physical barrier that can block airflow through mouthpiece 555) the mouthpiece (mouthpiece 555) to facilitate breathing through a nose of the user (inasmuch as providing a barrier to oral breathing prompts a user to breathe through their nose instead).
Regarding claim 18, Togliatti teaches the apparatus of claim 1. Togliatti teaches in the abstract that the mouthpiece (mouthpiece 555) complements continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) usage (inasmuch as the abstract teaches that the mouthpiece 555 functions to “alleviate problems including severe snoring and sleep apnea,” which is consistent with the function of continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) usage).
Regarding claim 19, Togliatti teaches the apparatus of claim 1. Togliatti teaches in the abstract that controlled airflow (unobstructed airflow through the user’s airway) helps reduce snoring (as taught in the abstract).
Regarding claim 20, Togliatti teaches in Figures 5(a) and 5(b), [0071], [0073], [0075-0076] and [0081-0082] providing ([0082] teaches “materials used to construct dental appliance 500”) a mouthpiece (dental appliance 500), the mouthpiece (dental appliance 500) comprising ([0071] teaches “dental appliance 500, which includes maxillary component 501, mandibular component 502, and tongue sleeve 503”): a first piece (maxillary component 501) configured to engage upper teeth of a user ([0073] teaches “maxillary component 501 includes a maxillary receptacle (receptacle 505) for receiving the maxillary teeth of a user”), the first piece (maxillary component 501) having a first end (forward, anterior end of maxillary component 501) and a second end (rearward, posterior end of maxillary component 501); a second piece (mandibular component 502) configured to engage lower teeth of the user ([0075] teaches “mandibular component 502 is adapted to receive a user's mandibular teeth”), the second piece (mandibular component 502) attached to (as shown in Figures 5(a) and 5(b); [0076] teaches “maxillary component 501 and mandibular component 502 of the mandibular advancement mouthpiece form an acute angle Φ with its vertex at a posterior region of the mandibular advancement mouthpiece 555”) the second end (rearward, posterior end of maxillary component 501) of the first piece (maxillary component 501); and a film (tongue sleeve 503) coupled between (as shown in Figures 5(a) and 5(b); [0071] teaches “tongue sleeve 503 may be situated between maxillary component 501 and mandibular component 502”) the first piece (maxillary component 501) and the second piece (mandibular component 502), the film (tongue sleeve 503) configured to control airflow through (inasmuch as the tongue sleeve 503 is shown in Figures 5(a) and 5(b) to be a physical barrier that can block airflow through dental appliance 500) the mouthpiece (dental appliance 500); inserting the mouthpiece (dental appliance 500) in a mouth of a user such that a first piece (maxillary component 501) of the mouthpiece (dental appliance 500) engages upper teeth of the user ([0075] teaches “maxillary component 501 is adapted to receive a user's maxillary teeth and includes outer ridge 504, inner ridge 506, and maxillary receptacle 505 between the outer and inner ridges for receiving the maxillary teeth of the user;” [0081] teaches “soft or somewhat malleable materials may be implemented so that maxillary component 501 and mandibular component 502 may cushion a user's teeth;” [0082] teaches “maxillary receptacle 505 and mandibular receptacle 508 may include a soft malleable surface so that teeth may be cushioned therein”), and a second piece (mandibular component 502) of the mouthpiece (dental appliance 500) engages lower teeth of the user ([0075] teaches “mandibular component 502 is adapted to receive a user's mandibular teeth and includes outer ridge 507, inner ridge 509, and mandibular receptacle 508 between the outer and inner ridges for receiving the mandibular teeth of the user;” [0081] teaches “soft or somewhat malleable materials may be implemented so that maxillary component 501 and mandibular component 502 may cushion a user's teeth;” [0082] teaches “maxillary receptacle 505 and mandibular receptacle 508 may include a soft malleable surface so that teeth may be cushioned therein”); and adjusting position of (by positioning and implementing, as taught in [0076]) the mouthpiece (dental appliance 500) to control airflow through ([0076] teaches “mouthpiece 555 includes one or more openings for enabling airflow between an exterior and interior of the mouthpiece”) the mouthpiece (dental appliance 500) to the mouth of the user ([0076] teaches “openings 510 and 511 allow a user to breathe through their mouth while the dental appliance is in use and the user's tongue is securely placed in tongue sleeve 503” and “the openings may be implemented so that a first opening is situated to the right of the tongue sleeve and a second opening is situated to the left of the tongue sleeve, wherein both the first and second openings are situated between the maxillary and mandibular components of the mouthpiece”).
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) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Togliatti (US 2018/0243124 A1).
Regarding claim 6, Togliatti teaches the apparatus of claim 1. The originally relied upon embodiment of Togliatti does not explicitly teach that the film is further configured to operate as a spring mechanism to allow relative movement of the first piece and the second piece between a first position and a second position.
However, Togliatti teaches in Figures 1(a)-2(b) and [0062] an alternate embodiment wherein the film (tongue receiving member 103c) is further configured to operate as a spring mechanism to allow relative movement of the first piece (maxillary component 101) and the second piece (mandibular component 102) between a first position and a second position ([0062] teaches the tongue receiving member 103c being made of rubber; rubber is an elastic material that is capable of acting as a spring mechanism to pull the maxillary component 101 and mandibular component 102 back together when stretched apart).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the film of the originally relied upon embodiment of Togliatti to be further configured to operate as a spring mechanism to allow relative movement of the first piece and the second piece between a first position and a second position as taught by the alternate embodiment of Togliatti because this element is a known medial grade polymer from which the film can be constructed, as Togliatti teaches in [0062].
Regarding claim 7, Togliatti teaches the apparatus of claims 1 and 6. Togliatti teaches in [0013] that a curvature of the film (tongue sleeve 503) is adjustable ([0013] teaches “the tongue sleeve is made of a flexible material, which may be squeezed;” flexing and/or squeezing the tongue sleeve 503 would change/adjust the curvature of the tongue sleeve 503).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Togliatti (US 2018/0243124 A1) in view of Singh (US 2012/0186589 A1).
Regarding claim 9, Togliatti teaches the apparatus of claim 1. Togliatti does not teach that one or more of the film, the first piece, or the second piece includes one or more holes configured to control the airflow through the mouthpiece.
However, Singh teaches in Figures 1-3 an analogous device wherein one or more of the film (formed by the plurality of connecting braces 16, as shown in Figures 1-3), the first piece (upper teeth fitting portion 12), or the second piece (lower teeth fitting portion 14) includes (as shown in Figures 1-3; [0021] teaches “a plurality of breathing openings 18 may be formed in between connecting braces 16”) one or more holes (plurality of breathing openings 18) configured to control the airflow through (by permitting breathing therethrough, as taught in [0021]) the mouthpiece (appliance 10).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify one or more of the film, the first piece, or the second piece of Togliatti to include one or more holes configured to control the airflow through the mouthpiece as taught by Singh because this element is known to permit breathing therethrough, as Singh teaches in [0021].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Togliatti (US 2018/0243124 A1) in view of Garabadian et al. (US 2011/0005526 A1).
Regarding claim 16, Togliatti teaches the apparatus of claim 1. Togliatti does not teach that the first piece and the second piece include one or more ridges configured to interlock the first piece and the second piece.
However, Garabadian et al. teaches in Figure 1, [0030-0031] and [0033] an analogous device wherein the first piece (upper tray 12) and the second piece (lower tray 14) include ([0030] teaches “a first upper ridge 22 is carried on and projects downwardly from a maxillary occlusal surface, designated generally as 24, of upper tray 12;” [0031] teaches “a lower ridge 28 is carried on and projects upwardly from a mandibular occlusal surface, designated generally as 30, of lower tray 14”) one or more ridges (first upper ridge 22, lower ridge 28) configured to interlock (via cooperation of first upper ridge 22 and lower ridge 28; [0033] teaches “first upper ridge 22 includes a first slanted engaging surface 42, and lower ridge 28 includes a second slanted engaging surface 44” and “first and second slanted engaging surfaces 42 and 44 are constructed and arranged to cooperate”) the first piece (upper tray 12) and the second piece (lower tray 14).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the first piece and the second piece of Togliatti to include one or more ridges configured to interlock the first piece and the second piece as taught by Garabadian et al. because this element is known “to define a bite gap between the upper tray and the lower tray for maintaining separation between the wearer's maxillary teeth and mandibular teeth” and “providing an opening for allowing forward movement of the wearer's tongue between the upper and lower trays,” as Garabadian et al. teaches in [0016], [0034] and [0036].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 8/11/2026
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