DETAILED ACTION
This action is in response to the Request for Continued Examination (RCE) filed 2/6/2025. Currently, claims 1, 3 and 7 are pending in the application. Claims 2, 4-6 and 8-20 are cancelled by Applicant.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/6/2025 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant’s cancellation of claim 12 is sufficient to overcome the previous objection to the drawings.
Applicant’s amendment to claim 7 is sufficient to overcome the previous objection to claim 7.
Applicant’s amendment to claim 3 is sufficient to overcome the previous rejection of claim 3 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant’s amendment to claim 7 is sufficient to overcome the previous rejections of claim 7 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant’s amendment to claim 7 is sufficient to overcome the previous rejections of claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Applicant’s arguments with respect to the Vaska reference have been fully considered and are persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of MUNEHIRO (US 2010/0184566 A1).
Drawings
The drawings are objected to because it is unclear what structure reference character “5” is intended to refer to (see Figure 1 filed 1/6/2025, which fails to include a directive arrow to indicate what structure is labeled using reference character “5”). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The amendment filed 1/6/2025 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: “the hollow area (11) has first hollow parts (12) intended to locate the user's incisors, second hollow parts (13) intended to locate the user's canines, and third hollow parts (14) intended to locate the user's premolars, and other parts intended to locate other features in the user's mouth” (see [0029]). No support is provided for this material in Applicant’s disclosure as originally filed. Applicant’s original disclosure does not teach the hollow area 11 having other parts being configured to locate any plurality of the remaining features (the tongue, soft palate, lingual frenulum, lower dentition, etc.) that are located in the user’s mouth. Applicant’s original disclosure only teaches the hollow area 11 being contoured to locate the teeth of the user’s upper jaw (as shown in Applicant’s original Figures 1-3, for instance).
Applicant is required to cancel the new matter in the reply to this Office Action.
The amendment filed 1/6/2025 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: “a gap (41) that may vary in distance” (see [0030]). No support is provided for this material in Applicant’s disclosure as originally filed. Applicant’s original disclosure does not teach a configuration in which the gap 41 (as defined in Applicant’s Figure 1) does not vary in distance (as permitted by the use of the term “may”). Applicant’s original disclosure only teaches a configuration in which the gap 41 does vary in distance, as shown in Applicant’s Figure 1.
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: in order to maintain consistency and clarity throughout the claim(s), “the extensions” (recited three times) in lines 15, 17 and 22 of the claim should be amended to recite ---the two extensions---. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the extensions” in line 23 of the claim should be amended to recite ---the two extensions---. 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 3 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 3 recites “a hollow area” in line 4 of the claim. It is unclear if this recited “hollow area” is the same as, or distinct from, the “hollow area” previously recited in line 3 of claim 1 (upon which claim 3 depends).
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 hollow area” in line 18 of the claim. It is unclear if this recited “hollow area” is the same as, or distinct from, the “hollow area” previously recited in line 3 of claim 7.
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 3 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 3 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 “the curved region bending downward, away from the upper jaw of the user,” which is a claim limitation indicating that Applicant is attempting to claim the upper jaw of the user (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claim 3 depends on claim 1 and therefore, includes the same error.
Claim 7 is 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.
Claim 7 is 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 7 recites “the curved region bends downward, away from the upper jaw of the user,” which is a claim limitation indicating that Applicant is attempting to claim the upper jaw of the user (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this 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, 3 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MUNEHIRO (US 2010/0184566 A1).
In regards to claim 1, MUNEHIRO teaches in claim 1, Figures 1-7, [0035] and [0044] a ferrule (the part of maxillary teeth contact 2, part of connection 3 and the part of maxillary anterior teeth contact 4) having a hollow area (hollow area bound by the part of right maxillary teeth occlusion contact 2a, the part of right maxillary teeth cheek side contact 2b and the part of right maxillary teeth tongue side contact 2c; hollow area bound by the part of left maxillary teeth occlusion contact 2d, the part of left maxillary teeth tongue side contact 2e and the part of left maxillary teeth cheek side contact 2f; shown in Figure 1) which fits onto teeth of only an upper jaw of a user ([0035] teaches “the part of maxillary teeth contact 2 and the part of maxillary anterior teeth contact 4 which can be set to the maxillary teeth”); the ferrule (the part of maxillary teeth contact 2, part of connection 3 and the part of maxillary anterior teeth contact 4) having (as shown in Figure 5) an anterior inner part (part of connection 3), a posterior final part (as defined in the annotated copy of Figure 5 provided below), and an interior region (as defined in the annotated copy of Figure 5 provided below); an arch (the part of palate contact 1 and the part of dorsum of tongue contact 5; shown in Figure 5 to be structured as a standing arch) having two extensions (as defined in the annotated copy of Figure 5 provided below) protruding from (as shown in Figure 5, the extensions protrude rearwardly away from the part of connection 3) the anterior inner part (part of connection 3) of the ferrule (the part of maxillary teeth contact 2, part of connection 3 and the part of maxillary anterior teeth contact 4) and having a curved region (as defined in the annotated copy of Figure 5 provided below); the two extensions (as defined in the annotated copy of Figure 5 provided below) connecting to the anterior inner part (part of connection 3) at only two (as shown in Figure 5) connection points (as defined in the annotated copy of Figure 5 provided below); the two extensions (as defined in the annotated copy of Figure 5 provided below) being spaced from (as shown in Figure 5) the interior region (as defined in the annotated copy of Figure 5 provided below) of the ferrule (the part of maxillary teeth contact 2, part of connection 3 and the part of maxillary anterior teeth contact 4) by a gap (as defined in the annotated copy of Figure 5 provided below), along an entire length of the extensions, except at (as shown in Figure 5) the two connection points (as defined in the annotated copy of Figure 5 provided below); the extensions (as defined in the annotated copy of Figure 5 provided below) being adapted to go parallel to (as shown by the arrows in the annotated copy of Figure 1 provided below) a bite plane of the user (as defined in the annotated copy of Figure 1 provided below) to a point near (as shown in Figure 1) the posterior final part (as defined in the annotated copy of Figure 5 provided below) of the ferrule (the part of maxillary teeth contact 2, part of connection 3 and the part of maxillary anterior teeth contact 4) at which point the extensions (as defined in the annotated copy of Figure 5 provided below) are joined together by (the annotated copy of Figure 5 provided below teaches the extensions being connected via the curved region at a location adjacent the posterior final part) the curved region (as defined in the annotated copy of Figure 5 provided below); the curved region (as defined in the annotated copy of Figure 5 provided below) bending downward, away from the upper jaw of the user (Figure 3 teaches the curved region being curved to bend downward in a direction away from the upper jaw of the user), to retain a tongue of the user ([0044] teaches “the part of dorsum of tongue contact 5 has a form convexed upward in order that a sufficient force is applied to tongue muscles 24”); and the extensions (as defined in the annotated copy of Figure 5 provided below) being adapted to incline fifteen degrees or less with respect to either side of (claim 1 teaches “a connection part being elastic;” thus, extensions are capable of being inclined to an angle of fifteen degrees or less with respect to either side of the bite plane by flexing the elastic part of connection 3 to move the extensions accordingly) the bite plane (as defined in the annotated copy of Figure 1 provided below).
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In regards to claim 3, MUNEHIRO teaches the apparatus of claim 1. MUNEHIRO teaches in Figures 1and 5 that the two connection points (as defined in the annotated copy of Figure 5 provided adjacent) are adjacent a hollow area (hollow area bound by the part of right maxillary teeth occlusion contact 2a, the part of right maxillary teeth cheek side contact 2b and the part of right maxillary teeth tongue side contact 2c; hollow area bound by the part of left maxillary teeth occlusion contact 2d, the part of left maxillary teeth tongue side contact 2e and the part of left maxillary teeth cheek side contact 2f; shown in Figure 1) of the ferrule (the part of maxillary teeth contact 2, part of connection 3 and the part of maxillary anterior teeth contact 4) intended to locate incisors, canines, or premolars (Figure 1 teaches the two connection points being positioned near the hollow area, which is shown in Figure 1 to be positioned such that the hollow area is capable of receiving a user’s premolars in use).
In regards to claim 7, MUNEHIRO teaches in claim 1, Figures 1-7, [0021], [0035], [0044] and [0063] an arch (the part of palate contact 1 and the part of dorsum of tongue contact 5; shown in Figure 5 to be structured as a standing arch); and a ferrule (the part of palate contact 1, the part of maxillary teeth contact 2, part of connection 3, the part of maxillary anterior teeth contact 4 the part of dorsum of tongue contact 5) configured with a hollow area (hollow area bound by the part of right maxillary teeth occlusion contact 2a, the part of right maxillary teeth cheek side contact 2b and the part of right maxillary teeth tongue side contact 2c; hollow area bound by the part of left maxillary teeth occlusion contact 2d, the part of left maxillary teeth tongue side contact 2e and the part of left maxillary teeth cheek side contact 2f; shown in Figure 1) to fit onto a user's teeth of only an upper jaw of a user ([0035] teaches “the part of maxillary teeth contact 2 and the part of maxillary anterior teeth contact 4 which can be set to the maxillary teeth”), the ferrule (the part of palate contact 1, the part of maxillary teeth contact 2, part of connection 3, the part of maxillary anterior teeth contact 4 the part of dorsum of tongue contact 5) incorporating (inasmuch as it is interpreted to include) said arch (the part of palate contact 1 and the part of dorsum of tongue contact 5), the ferrule (the part of palate contact 1, the part of maxillary teeth contact 2, part of connection 3, the part of maxillary anterior teeth contact 4 the part of dorsum of tongue contact 5) having (as shown in Figure 5) an anterior inner part (part of connection 3), a posterior final part (as defined in the annotated copy of Figure 5 provided above), and an interior region (as defined in the annotated copy of Figure 5 provided above); wherein: the arch (the part of palate contact 1 and the part of dorsum of tongue contact 5) is U-shaped (Figure 5 teaches the part of palate contact 1 and the part of dorsum of tongue contact 5 being structured as an inverted U-shape); the arch (the part of palate contact 1 and the part of dorsum of tongue contact 5) protrudes (as shown in Figure 5, the part of palate contact 1 and the part of dorsum of tongue contact 5 protrude rearwardly away from the part of connection 3) from the ferrule (the part of palate contact 1, the part of maxillary teeth contact 2, part of connection 3, the part of maxillary anterior teeth contact 4 the part of dorsum of tongue contact 5); the arch (the part of palate contact 1 and the part of dorsum of tongue contact 5) has two extensions (as defined in the annotated copy of Figure 5 provided above); the two extensions (as defined in the annotated copy of Figure 5 provided above) connect to the interior region (as defined in the annotated copy of Figure 5 provided above) of the ferrule (the part of palate contact 1, the part of maxillary teeth contact 2, part of connection 3, the part of maxillary anterior teeth contact 4 the part of dorsum of tongue contact 5) at only two (as shown in Figure 5) connection points (as defined in the annotated copy of Figure 5 provided above); the two connection points (as defined in the annotated copy of Figure 5 provided above) are at (as shown in Figure 5) the anterior inner part (part of connection 3) of the ferrule (the part of palate contact 1, the part of maxillary teeth contact 2, part of connection 3, the part of maxillary anterior teeth contact 4 the part of dorsum of tongue contact 5); the two connection points (as defined in the annotated copy of Figure 5 provided above) are distinct and separated from each other (as shown in the annotated copy of Figure 5 provided above); the two extensions (as defined in the annotated copy of Figure 5 provided above) are separated from (as shown in Figure 5) the interior region (as defined in the annotated copy of Figure 5 provided above) along their entire length except at (as shown in Figure 5) the two connection points (as defined in the annotated copy of Figure 5 provided above); the two connection points (as defined in the annotated copy of Figure 5 provided above) are adjacent a hollow area (hollow area bound by the part of right maxillary teeth occlusion contact 2a, the part of right maxillary teeth cheek side contact 2b and the part of right maxillary teeth tongue side contact 2c; hollow area bound by the part of left maxillary teeth occlusion contact 2d, the part of left maxillary teeth tongue side contact 2e and the part of left maxillary teeth cheek side contact 2f; shown in Figure 1) of the ferrule (the part of palate contact 1, the part of maxillary teeth contact 2, part of connection 3, the part of maxillary anterior teeth contact 4 the part of dorsum of tongue contact 5) intended to locate incisors, canines, or premolars of the user (Figure 1 teaches the two connection points being positioned near the hollow area, which is shown in Figure 1 to be positioned such that the hollow area is capable of receiving a user’s premolars in use); the two extensions (as defined in the annotated copy of Figure 5 provided above) are adapted to go parallel to (as shown by the arrows in the annotated copy of Figure 1 provided above) a bite plane of the user (as defined in the annotated copy of Figure 1 provided above) to a point near (as shown in Figure 1) the posterior final part (as defined in the annotated copy of Figure 5 provided above) of the ferrule (the part of palate contact 1, the part of maxillary teeth contact 2, part of connection 3, the part of maxillary anterior teeth contact 4 the part of dorsum of tongue contact 5) at which point are joined together by (the annotated copy of Figure 5 provided below teaches the extensions being connected via the curved region at a location adjacent the posterior final part) a curved region (as defined in the annotated copy of Figure 5 provided above); the two extensions (as defined in the annotated copy of Figure 5 provided above) are flexible (claim 1 teaches “a connection part being elastic;” thus, the extensions are capable of being flexed via elastic part of connection 3); the two extensions (as defined in the annotated copy of Figure 5 provided above) are adapted to incline fifteen degrees or less with respect to either side of (claim 1 teaches “a connection part being elastic;” thus, extensions are capable of being inclined to an angle of fifteen degrees or less with respect to either side of the bite plane by flexing the elastic part of connection 3 to move the extensions accordingly) the bite plane (as defined in the annotated copy of Figure 1 provided above); and the curved region (as defined in the annotated copy of Figure 5 provided above) bends downward, away from the upper jaw of the user (Figure 3 teaches the curved region being curved to bend downward in a direction away from the upper jaw of the user); whereby the arch (the part of palate contact 1 and the part of dorsum of tongue contact 5) can act to prevent a possible displacement of a tongue of the user towards a posterior part of an oral cavity of the user and consequently a possible obstruction of an airway ([0021] teaches that the applies “a strong stable burden on the dorsum of tongue;” [0044] teaches a sufficient force is applied to tongue muscles 24 when elevating tongue muscles 24;” these functions make the device capable of preventing a possible displacement of a tongue of the user towards a posterior part of an oral cavity of the user and consequently a possible obstruction of an airway, by applying a downward force on the tongue which may hold or move the tongue forward; [0063] teaches that the device “allows the learning of the correct position of the lingual apex,” which is a forward position of the lingual apex that prevents a possible displacement of a tongue of the user towards a posterior part of an oral cavity of the user and consequently a possible obstruction of an airway).
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 10/22/2025