DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the buffer of claims 6, 11, 21 and 26 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Objections
Claims 1-30 are objected to because of the following informalities: All of the claims include brackets around the claim number listing. This bracketing is confusing as it is unclear what the meaning of the bracketing is. It is suggested for each claim that the bracketing be removed from all the claims and that the word “Claim” is removed. Instead, the claim section may recite at the start of the section, for example, --The invention claimed is:-- before the first claim and each claim should be amended to recite only its number. For example, “[Claim 1]” should be amended to recite --1.--.
Claim 1 is objected to because of the following informalities: It recites, “A mouth guard that is formed by molding into a shape that corresponds individual teeth of a maxillary dentition or a mandibular dentition of a user, and is attached to the maxillary dentition”. The first occurrence of the word “that” renders the claim unclear. Further the word “to” appears to be missing after the word “correspond”. For clarity the claim should be amended to recite, for example, -- A mouth guard, the mouth guard formed by molding into a shape that corresponds to individual teeth of a maxillary dentition or a mandibular dentition of a user, the mouth guard attached to the maxillary dentition…--.
Claim 1 is objected to because of the following informalities: It recites, “a portion of the mouth guard that is positioned at a valley portion of at least one molar tooth of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition is formed into a shape that forms a gap between the portion and the valley portion of the molar tooth” which is unclear due to the word “that”. For clarity that it should recite, for example, --wherein a portion of the mouth guard is positioned at a valley portion of at least one molar tooth of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition and is formed into a shape that forms a gap between the portion and the valley portion of the molar tooth--.
Claim 2 recites the limitation “wherein a portion of the mouth guard that is positioned at a valley portion of at least one of a first premolar and a second premolar of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user” in lines 1-5 which is unclear due to the word “that”. It is suggested that it is amended to delete the word “that” and to recite, for example --wherein a portion of the mouth guard is positioned at a valley portion of at least one of a first premolar and a second premolar of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user and is formed into a shape that forms a gap between the portion of the mouth guard positioned at a valley portion of at least one of a first premolar and a second premolar and the valley portion of at least one of the first premolar and the second premolar--.
Claims 8 and 23 recite the limitation “wherein a portion of the mouth guard that is positioned at an anterior tooth occlusal portion of an anterior tooth of the maxillary dentition or the mandibular dentition is formed into a shape” at lines 1-3 which is unclear due to the word “that”. It is suggested that it is amended for clarity to recite –wherein a portion of the mouth guard is positioned at an anterior tooth occlusal portion of an anterior tooth of the maxillary dentition or the mandibular dentition and is formed into a shape…--.
Claims 15 and 29 are objected to because of the following informalities: They recite, “a gap forming model is mounted in anterior tooth occlusal portion of an anterior tooth”. It appears that it is a typographical error and should recite –a gap forming mold--.
Claim 17 recites the limitation “wherein a portion of the mouth guard that is positioned at a valley portion of at least one of a first molar and a second molar of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user is formed into a shape…” at lines 1-5 which is unclear due to the word “that”. It is suggested that it is amended for clarity to recite --wherein a portion of the mouthguard is positioned at a valley portion of at least one of a first molar and a second molar of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user and is formed into a shape …--.
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.
Claims 3-6, 13 and 18-21 are 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 the limitation “wherein the portion of the mouth guard that is positioned at the valley portion of the premolar” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as –wherein the portion of the mouth guard that is configured to be positioned at a valley portion of at least one of a first premolar and a second premolar of the maxillary dentition or the mandibular dentition is configured to be positioned at the valley portion of the first premolar and has either a convex cross-sectional shape…--.
Claim 4 recites the limitation “wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the premolar and a bottom of the valley portion of the premolar is 1. 0 to 5. 5 mm” in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as --wherein the portion of the mouth guard that is configured to be positioned at a valley portion of at least one of a first premolar and a second premolar of the maxillary dentition or the mandibular dentition is configured to be positioned at the valley portion of the first premolar and wherein a distance between an outer surface of the portion of the mouth guard that is configured to be positioned at the valley portion of the first premolar and a bottom of the valley portion of the first premolar is 1. 0 to 5. 5 mm--.
Claim 5 recites the limitation "the portion of the mouthguard that is positioned in the valley portion of the premolar" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as --the portion of the mouthguard that is configured to be positioned at a valley portion of at least one of a first premolar and a second premolar is configured to be positioned at the valley portion of the first premolar and the second premolar and has a convex cross-sectional shape that includes a first premolar protruding portion and a second premolar protruding portion each having a gap therein--.
Claim 6 recites the limitation “wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is positioned at the valley portion of the premolar” in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as --wherein the portion of the mouthguard that is configured to be positioned at the valley portion of at least one of a first premolar and a second premolar is configured to be positioned in the valley portion of the first premolar and wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is positioned at the valley portion of the first premolar--.
Claim 13 recites the limitation “wherein the portion of the mouth guard that is positioned at a valley portion of at least one of a first molar and a second molar of the maxillary dentition or the mandibular dentition has a shape that forms a gap…” in lines 1-5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as --wherein a portion of the mouth guard is positioned at a valley portion of at least one of a first molar and a second molar of the maxillary dentition or the mandibular dentition and has a shape that forms a gap…--.
Claim 18 recites the limitation “wherein the portion of the mouth guard that is positioned at the valley portion of the molar” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as –wherein the portion of the mouth guard that is configured to be positioned at the valley portion of at least one of the first molar and the second molar has either a convex cross-sectional shape…--.
Claim 19 recites the limitation “wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the molar and a bottom of the valley portion of the molar is 1. 0 to 6. 5 mm” in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as --wherein the portion of the mouth guard that is configured to be positioned at a valley portion of at least one of at least one of a first molar and a second molar of the maxillary dentition or the mandibular dentition is configured to be positioned at the valley portion of the first molar and wherein a distance between an outer surface of the portion of the mouth guard that is configured to be positioned at the valley portion of the first molar and a bottom of the valley portion of the first molar is 1. 0 to 6. 5 mm--.
Claim 20 recites the limitation “wherein the portion of the mouth guard that is positioned in the valley portion of the molar has a convex cross- sectional shape that includes a first molar protruding portion and a second molar protruding portion each having a gap therein” in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as -- wherein the portion of the mouth guard that is configured to be positioned at a valley portion of at least one of at least one of a first molar and a second molar of the maxillary dentition or the mandibular dentition is configured to be positioned at the valley portion of the first molar and the second molar portion and has a convex cross- sectional shape that includes a first molar protruding portion and a second molar protruding portion each having a gap therein--.
Claim 21 recites the limitation “wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is positioned at the valley portion of the molar” in lines 1-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as –wherein the portion of the mouth guard that is configured to be positioned at a valley portion of at least one of a first molar and a second molar is configured to be positioned at a first molar and wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is positioned at the valley portion of the first molar--.
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.
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 1-13 and 17-27 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 mouth guard that is formed by molding into a shape that corresponds individual teeth of a maxillary dentition or a mandibular dentition of a user, and is attached to the maxillary dentition or the mandibular dentition of the user” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite --A mouth guard that is formed by molding into a shape that is configure to correspond to individual teeth of a maxillary dentition or a mandibular dentition of a user, and is configured to be attached to the maxillary dentition or the mandibular dentition of the user--.
Claim 1 recites, “wherein a portion of the mouth guard that is positioned at a valley portion of at least one molar tooth of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition is formed into a shape that forms a gap between the portion and the valley portion of the molar tooth’” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite --wherein a portion of the mouth guard that is configured to be positioned at a valley portion of at least one molar tooth of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition is configured to be formed into a shape that forms a gap between the portion and the valley portion of the molar tooth--.
As claims 2-13 and 17-27 depend from claim 1, they are rejected for at least the same reasons as claim 1.
Claim 3 recites, “wherein the portion of the mouth guard that is positioned at the valley portion of the premolar has either a convex cross-sectional shape or a U-shaped cross-sectional shape” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein the portion of the mouth guard that is configured to be positioned at the valley portion of the premolar has either a convex cross-sectional shape or a U-shaped cross-sectional shape--.
Claim 4 recites “wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the premolar and a bottom of the valley portion of the premolar is 1. 0 to 5. 5 mm” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite --wherein a distance between an outer surface of the portion of the mouth guard that is configured to be positioned at the valley portion of the premolar and a bottom of the valley portion of the premolar is 1. 0 to 5. 5 mm--.
Claim 5 recites “wherein the portion of the mouth guard that is positioned in the valley portion of the premolar has a convex cross-sectional shape that includes a first premolar protruding portion and a second premolar protruding portion each having a gap therein” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite --wherein the portion of the mouth guard that is configured to be positioned in the valley portion of the premolar has a convex cross-sectional shape that includes a first premolar protruding portion and a second premolar protruding portion each having a gap therein--.
Claim 6 recites, “wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is positioned at the valley portion of the premolar” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is configured to be positioned at the valley portion of the premolar--.
Claim 8 recites, “wherein a portion of the mouth guard that is positioned at an anterior tooth occlusal portion of an anterior tooth of the maxillary dentition or the mandibular dentition is formed into a shape that forms a gap between the portion of the mouth guard and the anterior tooth occlusal portion of the anterior tooth when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user’” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein a portion of the mouth guard that is configured to be positioned at an anterior tooth occlusal portion of an anterior tooth of the maxillary dentition or the mandibular dentition is configured to be formed into a shape that forms a gap between the portion of the mouth guard and the anterior tooth occlusal portion of the anterior tooth when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user --.
Claims 9 and 24 recite “wherein the portion that is positioned at the anterior tooth occlusal portion of the anterior tooth has a shape selected from a group consisting of a convex cross-sectional shape, a U-shaped cross-sectional shape, and a flat cross-sectional shape.” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein the portion that is configured to be positioned at the anterior tooth occlusal portion of the anterior tooth has a shape selected from a group consisting of a convex cross-sectional shape, a U-shaped cross-sectional shape, and a flat cross-sectional shape--.
Claims 10 and 25 recite “wherein the portion that is positioned at the anterior tooth occlusal portion of the anterior tooth has a convex cross-sectional shape that includes an anterior tooth protruding portion having a gap therein.” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein the portion that is configured to be positioned at the anterior tooth occlusal portion of the anterior tooth has a convex cross-sectional shape that includes an anterior tooth protruding portion having a gap therein.--.
Claims 11 and 26 recite “wherein a buffer material is provided to an inner surface side of the portion that is positioned at the anterior tooth occlusal portion of the anterior tooth.” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein a buffer material is provided to an inner surface side of the portion that is configured to be positioned at the anterior tooth occlusal portion of the anterior tooth--.
Claim 18 recites, “wherein the portion of the mouth guard that is positioned at the valley portion of the molar has either a convex cross-sectional shape or a U-shaped cross-sectional shape” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein the portion of the mouth guard that is configured to be positioned at the valley portion of the molar has either a convex cross-sectional shape or a U-shaped cross-sectional shape--.
Claim 19 recites, “wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the molar and a bottom of the valley portion of the molar is 1. 0 to 6. 5 mm” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite --wherein a distance between an outer surface of the portion of the mouth guard that is configured to be positioned at the valley portion of the molar and a bottom of the valley portion of the molar is 1. 0 to 6. 5 mm --.
Claim 20 recites, “wherein the portion of the mouth guard that is positioned in the valley portion of the molar has a convex cross- sectional shape that includes a first molar protruding portion and a second molar protruding portion each having a gap therein” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein the portion of the mouth guard that is configured to be positioned in the valley portion of the molar has a convex cross- sectional shape…--.
Claim 21 recites, “wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is positioned at the valley portion of the molar” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite -- wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is configured to be positioned at the valley portion of the molar--.
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)(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, 5-6, 8-13, 17-18, 20-21 and 23-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsai (US 2022/0257344).
Regarding claim 1, Tsai discloses a mouth guard (10) ([0065]; capable of intended use) that is formed by molding into a shape that corresponds individual teeth of a maxillary dentition or a mandibular dentition of a user ([0066]; [0088]; Fig. 4A, Fig 4B; NOTE: shell 12 as seen in Fig. 1 includes cavities 14 that encapsulate a patient’s teeth and thus corresponds to individual teeth of for example a maxillary dentition; As to claim 1, the limitation, “molding into a shape that corresponds individual teeth of a maxillary dentition or a mandibular dentition” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “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). Thus, even if Tsai is silent as to the process used to form a shape that corresponds individual teeth of a maxillary dentition or a mandibular dentition”, the apparatus discloses is the same as claimed.), and is attached to the maxillary dentition or the mandibular dentition of the user ([0065]; [0066]; NOTE: as the shell of the aligner [mouth guard] encapsulates one or more crowns and each cavity receives a specific one of the patient’s teeth, it follows the mouthguard is attached to the maxillary dentition or to the mandibular dentition), the mouth guard having a thickness of 0.1 to 5.0 mm ([0118]; NOTE: the aligner [mouth guard] is 0.76mm thick which falls within the claimed range), wherein a portion of the mouth guard that is positioned at a valley portion of at least one molar tooth (50) (annotated Fig. 4A below; “at” is used as a function word to indicate presence or occurrence in, on, or near, merriamwebster.com; NOTE: a portion of the mouth guard is positioned near thus at a valley portion of the at least one molar tooth)
PNG
media_image1.png
759
807
media_image1.png
Greyscale
of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition ([0066]; NOTE: for example a shell for lower teeth is attached to the maxillary dentition when worn and a shell for the upper teeth is attached to the mandibular dentition when worn) is formed into a shape that forms a gap between the portion and the valley portion of the molar tooth (annotated Fig. 4A above).
Regarding claim 2, Tsai discloses the invention as described above with regard to claim 1.
Tsai further discloses wherein a portion of the mouth guard that is positioned at a valley portion of at least one of a first premolar and a second premolar of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user is formed into a shape that forms a gap between the portion of the mouth guard and the valley portion of at least one of the first premolar and the second premolar ([0074]; [0088]; NOTE: the bite structure 26 [portion of the mouth guard that is positioned at a valley portion] may form on other cavities [configured to receive a patient’s tooth] in addition to the molar and may form on one or more molars and/or premolars).
Regarding claim 3, Tsai discloses the invention as described above with regard to claim 2.
Tsai further discloses wherein the portion of the mouth guard that is positioned at the valley portion of the premolar has either a convex cross-sectional shape or a U-shaped cross-sectional shape ([0074]; NOTE: a bite structure which includes the portion as claimed may be positioned at a premolar as described above with regard to claim 2 and that bite structure as seen in annotated Fig. 4A with regard to the rejection to claim 1 has either a convex cross-sectional shape [annotated Fig. 4] or a U-shaped cross sectional shape).
Regarding claim 5, Tsai discloses the invention as described above with regard to claim 2.
Tsai further discloses wherein the portion of the mouth guard that is positioned in the valley portion of the premolar has a convex cross-sectional shape (see annotated Fig. 4A in the claim 1 rejection) that includes a first premolar protruding portion (annotated Fig.4A below)
PNG
media_image2.png
613
726
media_image2.png
Greyscale
and a second premolar protruding portion each having a gap therein (annotated Fig. 4A above; [0074]; NOTE: the same bite structure may be formed in one or more molars and premolars thus there would be a second premolar protruding portion having a gap therein and thus each protruding portion would have a gap therein).
Regarding claim 6, Tsai discloses the invention as described above with regard to claim 2.
Tsai further discloses wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is positioned at the valley portion of the premolar ([0066]; [0067]; NOTE: the mouth guard [aligner 12] has a shell that may be an elastic material in more than one layer and the bite structure 26 [portion of the mouth guard that is positioned at the valley portion of the premolar] is formed in the shell and thus would contain a multiple elastic layers, one of which would be a buffer material disposed on an inner surface of the portion of the mouth guard i.e. that is one of the elastic layers disposed above the layer nearest the valley portion of the premolar and that layer is capable of being a buffer in at least that it is elastic and can reduce shock) .
Regarding claims 8 and 23, Tsai discloses the invention as described above with regard to claim 2 and 17, respectively.
Tsai further discloses wherein a portion of the mouth guard that is positioned at an anterior tooth occlusal portion of an anterior tooth of the maxillary dentition or the mandibular dentition is formed into a shape that forms a gap between the portion of the mouth guard and the anterior tooth occlusal portion of the anterior tooth when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user ([0079]; [0074]; NOTE: cavity 66 which includes an occlusal portion 20 and which has a bite structure [portion of the mouthguard] is positioned at an anterior tooth as the tooth at which it is positioned may be a premolar that is anterior to rear molars and the occlusal portion would also have the bite structure).
Regarding claims 9 and 24, Tsai discloses the invention as described above with regard to claim 8 and claim 23, respectively.
Tsai further discloses wherein the portion that is positioned at the anterior tooth occlusal portion of the anterior tooth has a shape selected from a group consisting of a convex cross-sectional shape, a U-shaped cross-sectional shape, and a flat cross-sectional shape ([0074]; [0079]; see annotated Fig. 4A with regard to the claim 1 rejection which shows the portion [bite structure 26] has a convex-cross-sectional shape and as the occlusal portion 20 is at anterior tooth as described above with regard to claim 8 and as it includes the bite structure 26 [portion], it too would have a convex-cross-sectional shape for an anterior tooth such as a premolar as it does for a molar).
Regarding claims 10 and 25, Tsai discloses the invention as described above with regard to claims 8 and 23.
Tsai further discloses wherein the portion that is positioned at the anterior tooth occlusal portion of the anterior tooth has a convex cross-sectional shape (see description above with regard to the claim 9 rejection) that includes an anterior tooth protruding portion having a gap therein ([0074]; see annotated Fig. 4A with regard to the rejection to claim 1 showing the protruding portion having a gap therein and where for example cavity 66 includes the bite structure 26 [tooth protruding portion] it includes an anterior tooth protruding portion as the portion is at an anterior tooth [for example premolar] as described above with regard to claim 8).
Regarding claims 11 and 26, Tsai discloses the invention as described above with regard to claim 8 and claim 23, respectively.
Tsai further discloses wherein a buffer material is provided to an inner surface side of the portion that is positioned at the anterior tooth occlusal portion of the anterior tooth ([0066]; [0067]; NOTE: the mouth guard [aligner 12] has a shell that may be an elastic material in more than one layer and the bite structure 26 [portion of the mouth guard that is positioned at the valley portion of the premolar] is formed in the shell and thus would contain a multiple elastic layers, one of which would be a buffer material disposed on an inner surface of the portion of the mouth guard i.e. that is one of the elastic layers disposed above the layer nearest the gap of the anterior tooth [e.g. at cavity 66] and that layer is capable of being a buffer in at least that it is elastic and can reduce shock).
Regarding claims 12 and 27, Tsai discloses the invention as described above with regard to claim 8 and to claim 23, respectively.
Tsai further discloses wherein the anterior tooth is a central incisor ([0079]; [0074]; [0088]; NOTE: Tsai discloses that while a molar tooth 50 is shown and described, the bite structure 26 may form one or more occlusal portions of other cavities configured to receive a respective tooth and Tsai discloses that a cavity is configured to receive a central incisor as seen in Fig. 1, and further Tsai discloses that any molded tooth [which includes a central incisor as seen in Fig. 1 as a molded tooth] may be subject to modification to include the molded structure according to the process described).
Regarding claim 13, Tsai discloses the invention as described above with regard to claim 2.
Tsai further discloses wherein the portion of the mouth guard that is positioned at the valley portion of at least a first molar and a second molar of the maxillary dentition or the mandibular dentition has a shape that forms a gap between the portion of the mouth guard and the valley portion of at least one of the first molar and the second molar when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user ([0074]; Fig. 4A shows the gap as claimed for the first molar portion as described above with regard to claim 1 rejection and further Tsai discloses the same gap as claimed for the second molar portion as it discloses the bite portion is for with molars and premolars and thus for use with a second molar of the maxillary or mandibular dentition of the user when the mouth guard is attached as described with regard to the rejection to claim 1 above).
Regarding claim 17, Tsai discloses the invention as described above with regard to claim 1.
Tsai further discloses wherein a portion of the mouth guard that is positioned at a valley portion of at least one of a first molar and a second molar of the maxillary dentition or the mandibular dentition of the user when the mouth guard is attached to the maxillary dentition or the mandibular dentition of the user is formed into a shape that forms a gap between the portion of the mouth guard and the valley portion of at least one of the first molar and the second molar ([0074]; [0088]; NOTE: the bite structure 26 [portion of the mouth guard that is positioned at a valley portion] may form on other cavities [configured to receive a patient’s tooth] in addition to the molar and may form on one or more molars and/or premolars).
Regarding claim 18, Tsai discloses the invention as described above with regard to claim 17.
Tsai further discloses wherein the portion of the mouth guard that is positioned at the valley portion of the molar has either a convex cross-sectional shape or a U-shaped cross-sectional shape ([0074]; NOTE: a bite structure which includes the portion as claimed may be positioned at a molar as described above with regard to claim 1 and that bite structure as seen in annotated Fig. 4A with regard to the rejection to claim 1 has either a convex cross-sectional shape [annotated Fig. 4A] or a U-shaped cross sectional shape).
Regarding claim 20, Tsai discloses the invention as described above with regard to claim 17.
Tsai further discloses wherein the portion of the mouth guard that is positioned in the valley portion of the molar has a convex cross- sectional shape (see annotated Fig. 4A in the claim 1 rejection) that includes a first molar protruding portion and a second molar protruding portion (see annotated Fig. 4A with regard to the claim 5 rejection) each having a gap therein (annotated Fig. 4A above; [0074]; NOTE: the same bite structure may be formed in one or more molars and premolars thus there would be a second molar protruding portion having a gap therein and thus each protruding portion would have a gap therein).
Regarding claim 21, Tsai discloses the invention as described above with regard to claim 17.
Tsai further discloses wherein a buffer material is disposed on an inner surface of the portion of the mouth guard that is positioned at the valley portion of the molar ([0066]; [0067]; NOTE: the mouth guard [aligner 12] has a shell that may be an elastic material in more than one layer and the bite structure 26 [portion of the mouth guard that is positioned at the valley portion of the molar] is formed in the shell and thus would contain a multiple elastic layers, one of which would be a buffer material disposed on an inner surface of the portion of the mouth guard i.e. that is one of the elastic layers disposed above the layer nearest the valley portion of the molar and that layer is capable of being a buffer in at least that it is elastic and can reduce shock) .
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) 4 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US 2022/0257344) as applied to claims 2 and 17 above, respectively.
Regarding claim 4, Tsai discloses the invention as described above with regard to claim 2.
Tsai further discloses wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the premolar and a surface of the valley portion of the premolar is 1. 0 to 5. 5 mm ([0075]; see H1 in Fig. 4A).
Tsai does not explicitly disclose that a distance between an outer surface of the portion that is positioned at the valley portion of the premolar and a surface of the valley portion of the premolar is 1. 0 to 5. 5 mm.
However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that a distance between an outer surface of the portion of the mouth guard of Tsai that is positioned at the valley portion of the premolar and a surface of the valley portion of the premolar is 1. 0 to 5. 5 mm, as Applicant has appeared to place no criticality on the claimed range (Applicant’s specification at page 6, paragraph [19] recites “wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the molar and a bottom of the valley portion of the molar is 1. 0 to 6. 5 mm” and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220, F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, Tsai discloses the invention as described above with regard to claim 2.
Tsai further discloses wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the premolar and a surface of the valley portion of the premolar is 1. 0 to 5. 5 mm ([0075]; see H1 in Fig. 4A).
Tsai does not explicitly disclose that a distance between an outer surface of the portion that is positioned at the valley portion of the premolar and a surface of the valley portion of the premolar is 1. 0 to 5. 5 mm.
However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that a distance between an outer surface of the portion of the mouth guard of Tsai that is positioned at the valley portion of the premolar and a surface of the valley portion of the premolar is 1. 0 to 5. 5 mm, as Applicant has appeared to place no criticality on the claimed range (Applicant’s specification at page 6, paragraph [19] recites “wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the molar and a bottom of the valley portion of the molar is 1. 0 to 6. 5 mm” and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220, F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 19, Tsai discloses the invention as described above with regard to claim 17.
Tsai further discloses wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the molar and a surface of the valley portion of the molar is 1. 0 to 5. 5 mm ([0075]; see H1 in Fig. 4A).
Tsai does not explicitly disclose that a distance between an outer surface of the portion that is positioned at the valley portion of the premolar and a surface of the valley portion of the premolar is 1. 0 to 6. 5 mm.
However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that a distance between an outer surface of the portion of the mouth guard of Tsai that is positioned at the valley portion of the premolar and a surface of the valley portion of the premolar is 1. 0 to 6. 5 mm, as Applicant has appeared to place no criticality on the claimed range (Applicant’s specification at page 6, paragraph [19] recites “wherein a distance between an outer surface of the portion of the mouth guard that is positioned at the valley portion of the molar and a bottom of the valley portion of the molar is 1. 0 to 6. 5 mm” and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220, F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 7 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US 2022/0257344) as applied to claim 2 and 17, respectively above, and further in view of Fisher (US 2011/0162658).
Regarding claims 7 and 22, Tsai discloses the invention as described above with regard to claims 2 and 17, respectively.
Tsai further discloses wherein the mouth guard is formed by molding ([0081]) using a suitable thermally formable material ([0082]).
Tsai does not disclose wherein the mouth guard is formed by molding using an ethylene vinyl acetate resin.
Fisher teaches an analogous mouth guard (10) ([0017]; capable of intended use) wherein the mouth guard is formed by molding ([0019]) using ethylene vinyl acetate resin ([0019]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the mouth guard of Tsai that is formed by molding, is formed by molding using an ethylene vinyl acetate resin as taught by Fisher in order to provide an improved mouth guard that has a particular molding temperature and that facilitates molding to the shape of the user’s teeth (Fisher, [0019]).
Claim(s) 14-16 and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US 2022/0257344) in view of Yoshida (US 2021/0282651) and in further view of Yu (US 2023/0363858).
Regarding claim 14, Tsai discloses a method of manufacturing a mouth guard (10) ([0081] to [0089]) comprising mounting a gap forming mold (100) ([0081], [0082]; NOTE: the mold [workpiece may be a sheet of thermoplastic) in a valley portion of at least one of a first premolar and a second premolar of a dentition model (200) ([0074]; [0081];[0083]-[0088]; NOTE: the mold [workpiece 100] is mounted over a dentition model [mold 200]; NOTE: the mold 200 includes a molded structure 212 that forms a valley portion of a least one of a first premolar and a second premolar of a dentition model or for any molded tooth and which thus would also include for example, a molar, seen in Fig. 2A or any molded tooth which includes all the teeth seen in Fig. 1 and Fig. 6 and which thus includes a molar, a central incisor and a premolar, for example, and for a combination of teeth e.g.. for a premolar or any molded tooth which includes all of the teeth as seen in Fig. 1) that is formed by molding corresponding to a maxillary dentition or a mandibular dentition of a user ([0083]-[0088]; NOTE: the dentition model [mold 200] is formed by obtaining an impression of the patient’s dentition which is molding), forming into a shape that conforms to an outer shape of the teeth portions of the dentition model ([0085]; [0087]; Fig. 7; Fig. 1).
Tsai does not disclose covering the dentition model on which the gap forming mold is mounted by a heated thermoplastic resin sheet, and applying a vacuum suction to the thermoplastic resin sheet thus forming the thermoplastic sheet into a shape that conforms to an outer shape of the teeth portions of the dentition model.
Yoshida teaches an analogous method of manufacturing a mouth guard (1) ([0061]; [0071]; Fig. 2; capable of intended use) comprising mounting an analogous mold ([0071] NOTE: the thermoplastic polymeric compound sheet or film of Yoshida is analogous to the mold of Tsai which is also a thermoplastic) in a portion of an analogous dentition model ([0071]; tooth mold), covering the dentition model on which the analogous mold is mounted by a thermoplastic resin sheet (4) ([0071]; Fig. 4 shows a sheet), and applying a vacuum suction to the thermoplastic resin sheet ([0071]) thus forming the thermoplastic resin sheet into a shape that conforms to an outer shape of analogous teeth portions of the analogous dentition model ([0071]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the method of manufacturing a mouth guard of Tsai is further comprising covering the dentition model on which the gap forming mold is mounted by a thermoplastic resin sheet, and applying a vacuum suction to the thermoplastic resin sheet thus forming the thermoplastic sheet into a shape that conforms to an outer shape of the teeth portions of the dentition model, as taught by Yoshida, in order to provide an improved method that facilitates providing an electronic device such as a sensor (Yoshida, [0071]; [0004]).
Tsai in vies of Yoshida discloses the invention as described above.
Tsai in view of Yoshida does not disclose covering the dentition model on which the gap forming mold is mounted by a heated thermoplastic resin sheet.
Yu teaches an analogous method of manufacturing a mouth guard ([0068]; [0067]; dental appliance) comprising covering an analogous dentition model ([0069]) by an analogous thermoplastic resin sheet ([0024]; [0069] NOTE: sheet includes a semi-crystalline polymer that includes