DETAILED ACTION
This action is in response to the amendment filed 12/8/2025. Currently, claims 1 and 2 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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant’s amendment to the abstract is sufficient to overcome the previous objection to the specification.
Applicant’s amendment to claim 2 is sufficient to overcome the previous objection to claim 2.
Applicant’s amendment to claim 1 is sufficient to overcome the previous rejection of claims 1 and 2 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Applicant’s amendment to claim 1 is sufficient to overcome the previous rejection of claims 1 and 2 under 35 U.S.C. 101 and section 33(a) of the America Invents Act.
Applicant's arguments filed 12/8/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a non-enclosing surface-pressing body) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant’s argument that Ivanovich et al. does not teach the inner restrictive petal 5 being configured to deformably contact the lips to maintain sealing, the examiner respectfully disagrees. As detailed below, Ivanovich et al. teaches the stopper wing (50) (inner restrictive petal 5) being disposed in front of (as shown in Figure 1) the upper teeth stopper projection (20) (as defined in the annotated copy of Figure 1 provided below) and having a plate structure (as shown in Figure 3) configured to deformably ([0037] teaches the inner restrictive petal 5 being “made of elastic polymeric material,” which is a material that is capable of being deformed in use) contact the user's lips (4,5) (inner restrictive petal 5 is capable of being positioned in contact with a user’s lips) so as to stably position the preventing tool body (springy step bend 2 and cup-shaped fixture 3) at a limited insertion depth and maintain lip sealing during use ([0039] teaches “the inner restrictive petal 5 is placed between the inner surface of the lips and outer surface of the front teeth of the patient. An individual match of the distances between outer and inner restrictive petals 4 and 5 depending on the patients' individual anatomical features is performed by moving of the slots 7 and 8 of the connecting element 1 and fixing it in the chosen position on the ribbed surface;” thus, the position of the inner restrictive petal 5 is capable of being adjusted to seal against the user’s lips and to stabilize the springy step bend 2/cup-shaped fixture 3 at a particular depth in the user’s oral cavity).
Applicant's remaining arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Specification
The amendment filed 12/8/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: amendment to the abstract reciting that the stopper wing (50) functions “to prevent deep insertion of the device.” No support is provided for this disclosure in Applicant’s specification as originally filed. While Applicant’s original disclosure teaches the stopper wing (50) functioning “so the preventing tool body 10 can be prevented from being induced into the throat of the user and blocking the airway, which will enhance the safety” (see [0024] of the publication of the present application), Applicant’s original disclosure explicitly teaches that “the preventing tool body 10 extends back and forth to be placed deeply in the oral cavity of the user” such that “ejecting out of the body 10 from the oral cavity due to sleep apnea or coughing during sleeping can be effectively prevented” (see [0015] of the publication of the present application). [0021] of the publication of the present application further teaches “the preventing tool body 10 extends back and forth to be placed deeply in the oral cavity of the user, the preventing tool body 10 cannot easily ejected out of the oral cavity even though the user does the sleep apnea or coughs during sleeping.” Thus, Applicant’s original disclosure explicitly teaches that the stopper wing (50) is, in fact, deeply inserted in the user’s oral cavity, which is contrary to the language added via amendment.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “a rear portion of the preventing tool body (10),” which is a claim limitation lacking proper antecedent basis in the specification. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: claim 1 recites “a pair of open longitudinal air grooves (11, 12),” which is a claim limitation lacking proper antecedent basis in the specification. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: claim 1 recites the stopper wing (50) being “configured to deformably contact the user’s lips (4, 5),” which is a claim limitation lacking proper antecedent basis in the specification. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the front end” in line 30 of the claim should be amended to recite ---the front end portion---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the bottom surface” in line 31 of the claim should be amended to recite ---the bottom surface of the front end portion---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the preventing tool body” in line 36 of the claim should be amended to recite ---the preventing tool body (10)---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the oral cavity” in line 39 of the claim should be amended to recite ---the user’s oral cavity---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “a stopper wing (50) forwardly and outwardly extended from the preventing tool body (10).” No support is provided for this claim limitation in Applicant’s specification as originally filed. Specifically, Applicant’s original disclosure does not teach the stopper wing 50 extending forwardly from the preventing tool body 10. There is no such teaching in Applicant’s original specification. Further, Applicant’s Figure 3 teaches the stopper wing 50 being angled rearwardly along the preventing tool body 10, and not forwardly, as claimed. Claim 2 depends on claim 1 and therefore, includes the same error.
Claims 1 and 2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites the stopper wing (50) “having a plate structure.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s stopper wing 50 is taught in at least Figure 3 to have a substantial curvature, which is contrary to the presently claimed plate structure. Claim 2 depends on claim 1 and therefore, includes the same error.
Claims 1 and 2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites the stopper wing (50) functioning “to stably position the preventing tool body at a limited insertion depth and maintain lip sealing during use.” No support is provided for this claim limitation in Applicant’s specification as originally filed. First, Applicant’s original disclosure does not provide a discussion of the stopper wing 50 providing stability to the position of the preventing tool body 10 at a particular depth. Further, there is absolutely no teaching in Applicant’s original disclosure of a seal of, or with, the user’s lips being created during use of the present invention. Claim 2 depends on claim 1 and therefore, includes the same error.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 2 recites that the stopper wing (50) is moveable “to adjust the contact position relative to the user's lips.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not teach the stopper wing 50 being movable to change the position at which the stopper wing 50 contacts the user’s lips, as claimed. In fact, Applicant’s original disclosure teaches that “the stopper wing 50 can be selectively used according to the user's preference, and it can be adjusted along the front insert projection 50 according to the thickness and shape of the user's lips 4, 5” (see [0014] of the publication of the present application). This indicates that the stopper wing 50 is movable such that it can be removed as desired and further, to accommodate lips having varying thickness and shape, which is a functionality different than that claimed. Applicant’s original disclosure does not teach contact of the stopper wing 50 with the user’s lips being maintained during adjustment, as claimed.
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 2 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 2 recites “ a front end of the preventing tool body (10)” in line 11 of the claim. It is unclear if this recited “front end” is the same as, or distinct from, the “front end portion of the preventing tool body (10)” that is previously recited in claim 1 (upon which claim 2 depends).
Claim 2 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 2 recites the limitation "the contact position relative to the user’s lips" in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 2 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 and 2 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “a rear portion of the preventing tool body (10) extends backward along and presses an upper surface of the user's tongue (6),” which is a claim limitation indicating that Applicant is attempting to claim the user’s tongue (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claim 2 depends on claim 1 and therefore, includes the same error.
Claims 1 and 2 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 and 2 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “a pair of open longitudinal air grooves (11,12) formed on opposite side surfaces of the preventing tool body (10) and opening directly to the oral cavity,” which is a claim limitation indicating that Applicant is attempting to claim the oral cavity (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claim 2 depends on claim 1 and therefore, includes the same error.
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 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ivanovich et al. (US 2002/0144685 A1).
In regards to claim 1, Ivanovich et al. teaches in Figures 1-6, [0013], [0029], [0037] and [0039-0040]
a preventing tool body (10) (springy step bend 2 and cup-shaped fixture 3) having a convex bottom surface extending in a front-rear direction (Figure 1 teaches the lowermost surface of the cup-shaped fixture 3 being convex in the front-rear direction),
wherein,
a front end portion (springy step bend 2) of the preventing tool body (10) (springy step bend 2 and cup-shaped fixture 3) is configured to be inserted between upper teeth (2) and lower teeth (3) of a user (Figure 1 teaches the springy step bend 2 being positioned between the user’s upper and lower teeth in use), and a rear portion (cup-shaped fixture 3) of the preventing tool body (10) (springy step bend 2 and cup-shaped fixture 3) extends backward along (Figure 1 teaches the cup-shaped fixture 3 having a length that extends rearward along the user’s tongue) and presses an upper surface of the user's tongue (6) to maintain an open airway (Figure 1 teaches the cup-shaped fixture 3 being in contact with the top surface of the user’s tongue; [0029] teaches “the cup-shaped fixture 3 for the tongue tip;” [0039] teaches “the cup-shaped fixture 3 captures the tip of the tongue (see FIG. 1);” as shown in Figure 1, the cup-shaped fixture 3 presses the upper surface of the user’s tongue by having contact therewith to contain the tongue therein; [0013] teaches the device “providing optimal static and dynamic load on the tongue;” [0040] teaches “when the connecting element 1 is gripped between the front upper and lower teeth because of the step bend 2 the tongue goes down and releases the space between the palate and the tongue,” which functions to open the user’s airway);
an upper teeth stopper projection (20) (as defined in the annotated copy of Figure 1 provided below) provided on (as shown in Figure 1) an upper surface of (top surface) the front end portion (springy step bend 2) of the preventing tool body (10) (springy step bend 2 and cup-shaped fixture 3) and upwardly protruding (as shown in Figure 1) to prevent the upper teeth (2) from moving forward (the upper teeth stopper projection shown in Figure 1 is capable of being positioned in front of a user’s upper teeth to provide a physical barrier that prevents the upper teeth of the user from protruding forward);
a lower teeth guide slope portion (30) (as defined in the annotated copy of Figure 1 provided below) provided on a bottom surface (bottom surface) of the front end portion (springy step bend 2) of the preventing tool body (10) (springy step bend 2 and cup-shaped fixture 3) and inclined upward toward (Figure 1 teaches the lower teeth guide slope portion being angled upwardly in a direction that extends toward the anterior end of springy step bend 2) the front end (springy step bend 2) so that, when the lower teeth (3) bite (as shown in Figure 1) the bottom surface (bottom surface), the lower teeth (3) protrude forward further than the upper teeth (2) stopped by (as shown in Figure 1, a user’s lower teeth are capable of being positioned against the lower teeth guide slope portion, which would position the lower teeth more forward than the upper teeth when the user’s upper teeth are positioned behind the upper teeth stopper projection) the upper teeth stopper projection (20) (as defined in the annotated copy of Figure 1 provided below);
a stopper wing (50) (inner restrictive petal 5) forwardly and outwardly extended from (as shown in Figure 1, the inner restrictive petal 5 is positioned forward of the cup-shaped fixture 3 and projects radially outward away from springy step bend 2) the preventing tool body (10) (springy step bend 2 and cup-shaped fixture 3), the stopper wing (50) (inner restrictive petal 5) being disposed in front of (as shown in Figure 1) the upper teeth stopper projection (20) (as defined in the annotated copy of Figure 1 provided below) and having a plate structure (as shown in Figure 3) configured to deformably ([0037] teaches the inner restrictive petal 5 being “made of elastic polymeric material,” which is a material that is capable of being deformed in use) contact the user's lips (4,5) (inner restrictive petal 5 is capable of being positioned in contact with a user’s lips) so as to stably position the preventing tool body (springy step bend 2 and cup-shaped fixture 3) at a limited insertion depth and maintain lip sealing during use ([0039] teaches “the inner restrictive petal 5 is placed between the inner surface of the lips and outer surface of the front teeth of the patient. An individual match of the distances between outer and inner restrictive petals 4 and 5 depending on the patients' individual anatomical features is performed by moving of the slots 7 and 8 of the connecting element 1 and fixing it in the chosen position on the ribbed surface;” thus, the position of the inner restrictive petal 5 is capable of being adjusted to seal against the user’s lips and to stabilize the springy step bend 2/cup-shaped fixture 3 at a particular depth in the user’s oral cavity); and
a pair of open longitudinal air grooves (11,12) (left and right openings into the cavity formed by cup-shaped fixture 3) formed on opposite side surfaces (left and right perimeter edges) of the preventing tool body (10) (springy step bend 2 and cup-shaped fixture 3) and opening directly to the oral cavity so that outer air flows into the oral cavity of the user (the left and right openings into the cavity formed by cup-shaped fixture 3 are capable of being positioned in the user’s mouth such that they open directly to the oral cavity; air external to the oral cavity is capable of flowing along the left and right openings into the cavity formed by cup-shaped fixture 3).
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In regards to claim 2, Ivanovich et al. teaches the apparatus of claim 1. Ivanovich et al. teaches in Figures 1, 3 and 5, [0033] and [0039] that the stopper wing (50) (inner restrictive petal 5) includes (as shown in Figure 3; [0033] teaches “the outer and inner restrictive petals 4, 5, provided with the slots 6 and 7”) an insert hole (51) (slot 7) extending in the front-rear direction (Figure 1 teaches the slot 7 having a depth extending in the front-rear direction; Figure 1 teaches the slot 7 extending through the inner restrictive petal 5 in the anterior to posterior direction), and the preventing tool body (10) (springy step bend 2 and cup-shaped fixture 3) further includes a front inserting projection (40) (connecting element 1) extending forward from a front end of (Figure 1 teaches the connecting element 1 extending forward from the anterior end of springy step bend 2) the preventing tool body (10) (springy step bend 2 and cup-shaped fixture 3) and releasably engaged into ([0033] teaches “the surface of the connecting element 1 is ribbed performed for providing the regulated moving and fixing on it of the outer and inner restrictive petals 4, 5, provided with the slots 6 and 7 corresponding to the form of the cross section of the connecting element 1;” [0039] teaches “an individual match of the distances between outer and inner restrictive petals 4 and 5 depending on the patients' individual anatomical features is performed by moving of the slots 7 and 8 of the connecting element 1 and fixing it in the chosen position on the ribbed surface”) the insert hole (51) (slot 7), whereby the stopper wing (50) (inner restrictive petal 5) is movable back and forth along the front inserting projection (40) (connecting element 1) to adjust the contact position relative to the user's lips ([0033] teaches “the surface of the connecting element 1 is ribbed performed for providing the regulated moving and fixing on it of the outer and inner restrictive petals 4, 5, provided with the slots 6 and 7 corresponding to the form of the cross section of the connecting element 1;” [0039] teaches “an individual match of the distances between outer and inner restrictive petals 4 and 5 depending on the patients' individual anatomical features is performed by moving of the slots 7 and 8 of the connecting element 1 and fixing it in the chosen position on the ribbed surface”).
Conclusion
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 3/11/2026