DETAILED ACTION
This action is in response to the Response to Election/Restriction filed 10/8/2025. Currently, claims 1-17 are pending in the application. Claims 7-9 are withdrawn and not examined at this point.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species I, Figures 1-3 (corresponding to claims 1-6 and 10-17) in the reply filed on 10/8/2025 is acknowledged.
Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/8/2025. Claim 10 depends on withdrawn claim 9 and therefore, is also withdrawn.
Claim 12 is withdrawn from further consideration as being drawn to a nonelected species. Claims 12 recites “an anterior bite surface.” The anterior bite surface (225) is taught in Applicant’s disclosure to be a feature of non-elected Species 3, Figures 12-14, with the anterior bite surface (225) being illustrated in Applicant’s Figures 12 and 13. The anterior bite surface (225) is not disclosed to be a feature of elected Species I, Figures 1-3. Claim 12, therefore, is withdrawn.
Claim 13 is withdrawn from further consideration as being drawn to a nonelected species. Claims 13 recites “the upper tray further comprises a right side rear fastener extending rearwardly from a posterior portion of the right side of the upper tray and a left side rear fastener extending rearwardly from a posterior portion of the left side of the upper tray.” The right side rear fastener (410) extending rearwardly from a posterior portion of the right side of the upper tray (100) and the left side rear fastener (410) extending rearwardly from a posterior portion of the left side of the upper tray (100) are taught in Applicant’s disclosure to be a feature of non-elected Species 4, Figures 15 and 16, with the right and left side rear fasteners (410) being illustrated in Applicant’s Figures 15 and 16. The right and left side rear fasteners (410) are not disclosed to be a feature of elected Species I, Figures 1-3. Claim 13, therefore, is withdrawn. Claims 14 and 15 depend on claim 13 and therefore, are also withdrawn.
Claim 16 is withdrawn from further consideration as being drawn to a nonelected species. Claims 16 recites “an opening in a lower anterior surface of the lower tray to guide placement of the subject's tongue.” The opening (250) in a lower anterior surface of the lower tray to guide placement of the subject's tongue is taught in Applicant’s disclosure to be a feature of non-elected Species 2, Figures 4-11, with the opening (250) being illustrated in Applicant’s Figure 9. The opening (250) is not disclosed to be a feature of elected Species I, Figures 1-3. Claim 16, therefore, is withdrawn.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract includes legal phraseology, which is not permitted. The term “comprising” should be removed from the abstract to avoid this error. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the right maxillary first bicuspid and/or the right maxillary second bicuspid” in line 11 of the claim should be amended to recite ---the right maxillary first bicuspid and/or the right maxillary second bicuspid of the subject---. 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 left maxillary first bicuspid and/or the left maxillary second bicuspid” in lines 15-16 of the claim should be amended to recite ---the left maxillary first bicuspid and/or the left maxillary second bicuspid of the subject---. 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 right mandibular first bicuspid and/or the right mandibular second bicuspid” in lines 26-27 of the claim should be amended to recite ---the right mandibular first bicuspid and/or the right mandibular second bicuspid of the subject---. 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 left mandibular first bicuspid and/or the left mandibular second bicuspid” in lines 30-31 of the claim should be amended to recite ---the left mandibular first bicuspid and/or the left mandibular second bicuspid of the subject---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “a right mandibular molar” in line 34 of the claim should be amended to recite ---a right mandibular molar of the subject---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “a left mandibular molar” in line 37 of the claim should be amended to recite ---a left mandibular molar of the subject---. Appropriate correction is required.
Claims 1-6 and 11-17 are objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), all recitations of “the appliance” should be amended to recite ---the sleep apnea oral appliance---. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the left maxillary first bicuspid” in line 3 of the claim should be amended to recite ---the left maxillary first bicuspid of the subject---. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: in order to correct a typographical error, “formed in the lower surface for and adapted to retain the right maxillary first bicuspid” in lines 4-5 of the claim should be amended to recite ---formed in the lower surface and adapted to retain the right maxillary first bicuspid---. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the right maxillary first bicuspid” in line 5 of the claim should be amended to recite ---the right maxillary first bicuspid of the subject---. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the left mandibular first bicuspid” in line 3 of the claim should be amended to recite ---the left mandibular first bicuspid of the subject---. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the right mandibular first bicuspid” in line 5 of the claim should be amended to recite ---the right mandibular first bicuspid of the subject---. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the right maxillary first bicuspid and/or the right maxillary second bicuspid” in line 13 of the claim should be amended to recite ---the right maxillary first bicuspid and/or the right maxillary second bicuspid of the subject---. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the left maxillary first bicuspid and/or the left maxillary second bicuspid” in line 17 of the claim should be amended to recite ---the left maxillary first bicuspid and/or the left maxillary second bicuspid of the subject---. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the right mandibular first bicuspid and/or the right mandibular second bicuspid” in lines 27-28 of the claim should be amended to recite ---the right mandibular first bicuspid and/or the right mandibular second bicuspid of the subject---. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the left mandibular first bicuspid and/or the left mandibular second bicuspid” in lines 31-32 of the claim should be amended to recite ---the left mandibular first bicuspid and/or the left mandibular second bicuspid of the subject---. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “a right mandibular molar” in line 35 of the claim should be amended to recite ---a right mandibular molar of the subject---. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “a left mandibular molar” in line 38 of the claim should be amended to recite ---a left mandibular molar of the subject---. 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 1-6 and 11 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 1 recites “a portion of the receptacle formed in the upper surface” in line 14 of the claim. It is unclear if this recited “portion of the receptacle formed in the upper surface” is the same as, or distinct from, the “portion of the receptacle formed in the upper surface” that is previously recited in line 10 of the claim. Claims 2-6 and 11 depend on claim 1 and therefore, include the same error.
Claims 1-6 and 11 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 1 recites “a portion of the receptacle formed in the lower surface” in line 29 of the claim. It is unclear if this recited “portion of the receptacle formed in the lower surface” is the same as, or distinct from, the “portion of the receptacle formed in the lower surface” that is previously recited in line 25 of the claim. Claims 2-6 and 11 depend on claim 1 and therefore, include the same error.
Claims 1-6 and 11 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 1 recites “a portion of the receptacle formed in the lower surface” in line 33 of the claim. It is unclear if this recited “portion of the receptacle formed in the lower surface” is the same as, or distinct from, the “portion of the receptacle formed in the lower surface” that is previously recited in line 25 of the claim. Claims 2-6 and 11 depend on claim 1 and therefore, include the same error.
Claims 1-6 and 11 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 1 recites “a portion of the receptacle formed in the lower surface” in line 36 of the claim. It is unclear if this recited “portion of the receptacle formed in the lower surface” is the same as, or distinct from, the “portion of the receptacle formed in the lower surface” that is previously recited in line 25 of the claim. Claims 2-6 and 11 depend on claim 1 and therefore, include the same error.
Claims 1-6 and 11 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 1 recites the limitation "the forces exerted by the second orthodontic elastic band and the fourth orthodontic elastic band" in lines 50-51. There is insufficient antecedent basis for this limitation in the claim. Claims 2-6 and 11 depend on claim 1 and therefore, include the same error.
Claims 1-6 and 11 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 1 recites the limitation "the forces exerted by the second orthodontic elastic band and the fourth orthodontic elastic band" in lines 52-53. There is insufficient antecedent basis for this limitation in the claim. Claims 2-6 and 11 depend on claim 1 and therefore, include the same error.
Claim 17 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 17 recites “a portion of the receptacle formed in the upper surface” in line 16 of the claim. It is unclear if this recited “portion of the receptacle formed in the upper surface” is the same as, or distinct from, the “portion of the receptacle formed in the upper surface” that is previously recited in line 12 of the claim.
Claim 17 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 17 recites “a portion of the receptacle formed in the upper surface” in line 30 of the claim. It is unclear if this recited “portion of the receptacle formed in the upper surface” is the same as, or distinct from, the “portion of the receptacle formed in the upper surface” that is previously recited in line 26 of the claim.
Claim 17 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 17 recites “a portion of the receptacle formed in the upper surface” in line 34 of the claim. It is unclear if this recited “portion of the receptacle formed in the upper surface” is the same as, or distinct from, the “portion of the receptacle formed in the upper surface” that is previously recited in line 26 of the claim.
Claim 17 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 17 recites “a portion of the receptacle formed in the upper surface” in line 37 of the claim. It is unclear if this recited “portion of the receptacle formed in the upper surface” is the same as, or distinct from, the “portion of the receptacle formed in the upper surface” that is previously recited in line 26 of the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tousssaint (US 2011/0155144 A1), in view of Callender (US 2009/0036889 A1) and further in view of Singer, et al. (US 2013/0295517 A1).
In regards to claim 1, Tousssaint discloses a sleep apnea oral appliance (adjustable mandibular protrusion splint for treating snoring and obstructive sleep apnea, title, abstract), comprising:
(a) an upper tray (upper part 3 including tray 3a, Fig 8, p. [0012]) having an upper surface (“upper surface” is defined by the superior most surface of upper tray 3a, see annotated Fig 8 below), a lower surface (“lower surface” is defined by the posterior most surface of upper tray 3a, see annotated Fig 8 below), an anterior portion (“anterior portion” is defined by the front portion of upper tray 3a which would correspond to the user’s front/forward most teeth, see annotated Fig 8 below), a posterior portion (“posterior portion” is defined as the back portion of upper tray 3a which would correspond to the user’s molars/back most teeth, see annotated Fig 8 below), a right side (“right side” is defined as the right side of upper tray 3a, see annotated Fig 8 below), a left side (“left side” is defined as the left side of upper tray 3a, see annotated Fig 8 below), a buccal portion (“buccal portion” is defined by the walls of the upper tray 3a that face towards the cheek when the appliance is worn in the mouth, see annotated Fig 8 below), a labial portion (“labial portion” is defined by the walls of the upper tray 3a that are located at the lips when the device is worn in the mouth, see annotated Fig 8 below), and an outer surface (“outer surface” is defined by the exterior walls the encompass the shape of the upper tray 3a, see annotated Fig 8 below), the upper tray comprising:
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a receptacle formed in the upper surface (inside of the bottom of the maxillary tray 11, see annotated Fig 8 below, Figs 2 and 8, p. [0036]), the receptacle formed in the upper surface (inside of the bottom of the maxillary tray 11, see annotated Fig 8 below, Figs 2 and 8, p. [0036]) having an inner surface formed to retain the maxillary teeth of a subject (inside of the bottom of the maxillary tray 11 holds the upper maxillary teeth, Figs 2 and 8, p. [0036, 0012, 0015]), wherein the receptacle formed in the upper surface (as defined in the annotated copy of Figure 8 provided below) is adapted to reversibly retain the subject’s teeth ([0011] teaches the tray 3a being open toward the maxilla for reception of the maxillary teeth therein; Tousssaint does not teach a structure that prevents removal of the tray 3a from the user’s teeth);
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a right side fastener (front fixing knob 5b of upper tray 3a is located on the right side, Figs 2 and 8, p. [0042, 0050]) extending buccally from the outer surface of the upper tray adjacent a portion of the receptacle formed in the upper surface is adapted to retain the right maxillary first bicuspid and/or the right maxillary second bicuspid (front fixing knob 5b extends buccally from the “outer surface” on the right side of the upper tray 3a towards the cheek of the mouth when worn and is adjacent to the maxillary teeth of the wearer, Figs 2 and 8, p. [0042, 0050]); and
a left side fastener (front fixing knob 5a is located on the left side, Figs 2 and 8, p. [0042, 0050]) extending buccally from the outer surface of the upper tray adjacent a portion of the receptacle formed in the upper surface is adapted to retain the left maxillary first bicuspid and/or the left maxillary second bicuspid (front fixing knob 5a extends buccally from the “outer surface” on the left side of the upper tray 3a towards the cheek of the mouth when worn and is adjacent to the maxillary teeth of the wearer, Figs 2 and 8, p. [0042, 0050]);
(b) a lower tray (lower part 2 including tray 2a, Fig 8, p. [0012]) having an upper surface (“upper surface” is defined by the superior most surface of lower tray 2a, this surface contacts the lower surface of the upper tray 3a, see annotated Fig 8 below), a lower surface (“lower surface” is defined by the posterior most surface of lower tray 2a, see annotated Fig 8 below), an anterior portion (“anterior portion” is defined by the front portion of lower tray 2a which would correspond to the user’s front/forward most teeth, see annotated Fig 8 below), a posterior portion (“posterior portion” is defined as the back portion of lower tray 2a which would correspond to the user’s molars/back most teeth, see annotated Fig 8 below), a right side (“right side” is defined as the right side of lower tray 2a, see annotated Fig8 below), a left side (“left side” is defined as the left side of lower tray 2a, see annotated Fig 8 below), a buccal portion (“buccal portion” is defined by the walls of the lower tray 2a that face towards the cheek when the appliance is worn in the mouth, see annotated Fig 8 below), a labial portion (“labial portion” is defined by the walls of the lower tray 2a that are located at the lips when the device is worn in the mouth, see annotated Fig 8 below), and an outer surface (“outer surface” is defined by the exterior walls the encompass the shape of the lower tray 2a, see annotated Fig 8 below), the lower tray comprising:
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a receptacle formed in the lower surface (inside of the bottom of the mandibular tray 12, see annotated Fig 8 below, Figs 2 and 8, p. [0036]), the receptacle formed in the lower surface (inside of the bottom of the mandibular tray 12, see annotated Fig 8 below, Figs 2 and 8, p. [0036]) having an inner surface adapted to retain the mandibular teeth of the subject (inside of the bottom of the mandibular tray 12 holds the lower mandibular teeth, Figs 8, p. [0036, 0012, 0015]), wherein the receptacle (as defined in the annotated copy of Figure 8 provided below) formed in the lower surface is adapted to reversibly retain the subject’s teeth ([0011] teaches the tray 2a being open toward the mandibula for reception of the mandibular teeth therein; Tousssaint does not teach a structure that prevents removal of the tray 2a from the user’s teeth);
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a right side anterior fastener (front fixing knob 7b of lower tray 2a is located on the anterior right side, Fig 8, p. [0042, 0050]) extending buccally from the outer surface of the lower tray adjacent a portion of the receptacle formed in the lower surface is adapted to retain the right mandibular first bicuspid and/or the right mandibular second bicuspid (front fixing knob 7b extends buccally from the “outer surface” on the anterior right side of the lower tray 2a towards the cheek of the mouth when worn and is adjacent to the anterior maxillary teeth of the wearer, Figs 2 and 8, p. [0042, 0050]);
a left side anterior fastener (front fixing knob 7a of lower tray 2a is located on the anterior left side, Fig 8, p. [0042, 0050]) extending buccally from the outer surface of the lower tray adjacent a portion of the receptacle formed in the lower surface is adapted to retain the left mandibular first bicuspid and/or the left mandibular second bicuspid (front fixing knob 7a extends buccally from the “outer surface” on the anterior left side of the lower tray 2a towards the cheek of the mouth when worn and is adjacent to the anterior maxillary teeth of the wearer, Figs 2 and 8, p. [0042, 0050]);
a right side posterior fastener (rear fixing knob 8b of lower tray 2a is located on the posterior right side, Fig 8, p. [0042, 0050]) extending buccally from the outer surface of the lower tray adjacent a portion of the receptacle formed in the lower surface is adapted to retain a right mandibular molar (rear fixing knob 8b extends buccally from the “outer surface” on the posterior right side of the lower tray 2a towards the cheek of the mouth when worn and is adjacent to the posterior maxillary teeth of the wearer, Figs 2 and 8, p. [0042, 0050]); and
a left side posterior fastener (rear fixing knob 8a of lower tray 2a is located on the posterior left side, Fig 8, p. [0042, 0050]) extending buccally from the outer surface of the lower tray adjacent a portion of the receptacle formed in the lower surface is adapted to retain a left mandibular molar (rear fixing knob 8a extends buccally from the “outer surface” on the posterior left side of the lower tray 2a towards the cheek of the mouth when worn and is adjacent to the posterior maxillary teeth of the wearer, Figs 2 and 8, p. [0042, 0050]);
(c) an elastic band (protrusion holders 9 are made from an elastic material, p. [0036]) connecting the right side fastener of the upper tray to the right side posterior fastener of the lower tray (protrusion holder 9 has a first end that connects between the right front fixing knob 5b of the upper tray 3a and a second end that attaches to the right rear fixing knob 8b of the lower tray 2a, Figs 1 and 8, p. [0036, 0042-0043, 0050]); and
(d) an elastic band (protrusion holders 9 are made from an elastic material, p. [0036]) connecting the left side fastener of the upper tray to the left side posterior fastener of the lower tray (protrusion holder 9 has a first end that connects between the left front fixing knob 5a of the upper tray 3a and a second end that attaches to the left rear fixing knob 8a of the lower tray 2a, Figs 1 and 8, p. [0036, 0042-0043, 0050]),
wherein the appliance is removable (adjustable mandibular protrusion splint for treating snoring and obstructive sleep apnea is worn by the user at night and can be removed during the day or for adjustments to the appliance, p. [0040, 0059-0061]) and accomplishes mandibular advancement during use by the subject (with the aid of the protrusion holders the mandibular advancement can easily be customized to the requirements of each user, p. [0030, 0011, 0016, 0061]).
While Tousssaint discloses an elastic band connecting the right side fastener of the upper tray to the right side posterior fastener of the lower tray; and an elastic band connecting the left side fastener of the upper tray to the left side posterior fastener of the lower tray (see above), Tousssaint does not explicitly disclose a first orthodontic elastic band connecting the right side fastener of the upper tray to the right side anterior fastener of the lower tray and a second orthodontic elastic band connecting the right side fastener of the upper tray to the right side posterior fastener of the lower tray, wherein each of the first and second orthodontic elastic bands exerts a force of no more than 3 Newtons when placed under tension; and a third orthodontic elastic band connecting the left side fastener of the upper tray to the left side anterior fastener of the lower tray and a fourth orthodontic elastic band connecting the left side fastener of the upper tray to the left side posterior fastener of the lower tray, wherein each of the third and fourth orthodontic elastic bands exerts a force of no more than 3 Newtons when placed under tension, and wherein the forces exerted by the first orthodontic elastic band and the third orthodontic elastic band control vertical positioning of the upper tray with respect to the lower tray, wherein the forces exerted by the second orthodontic elastic band and the fourth orthodontic elastic band control anterior-posterior movement of the upper tray with respect to the lower tray, and wherein the forces exerted by the first orthodontic elastic band, the second orthodontic elastic band, the third orthodontic elastic band, and the fourth orthodontic elastic band allow movement of the subject’s jaw while maintaining the upper tray and lower tray in a position which alleviates snoring and apnea in the subject.
However, Callender teaches in Figure 8, [0012], [0027] and [0038] (note: while only one side of the user’s dentition is shown in Figure 8, the arrangements on the left and right sides of the user’s dentition are understood to be identical) an analogous device with a first orthodontic elastic band (right side forwardmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”) connecting (as shown in Figure 8) the right side fastener (right side upper bone screw 20) of the upper tray (upper section 31) to the right side anterior fastener (right side mandibular bone screw 22d) of the lower tray (lower section 32) and a second orthodontic elastic band (right side rearmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”) connecting (as shown in Figure 8) the right side fastener (right side upper bone screw 20) of the upper tray (upper section 31) to the right side posterior fastener (right side mandibular bone screw 22a) of the lower tray (lower section 32); and a third orthodontic elastic band (left side forwardmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”) connecting (as shown in Figure 8) the left side fastener (left side upper bone screw 20) of the upper tray (upper section 31) to the left side anterior fastener (left side mandibular bone screw 22d) of the lower tray (lower section 32) and a fourth orthodontic elastic band (left side rearmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”) connecting (as shown in Figure 8) the left side fastener (left side upper bone screw 20) of the upper tray (upper section 31) to the left side posterior fastener (left side mandibular bone screw 22a) of the lower tray (lower section 32), and wherein the forces exerted by the first orthodontic elastic band (right side forwardmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”) and the third orthodontic elastic band (left side forwardmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”) control vertical positioning of ([0027] teaches that the elastics 25 “exert forces that tend move the mandible 10 forward and upward with respect to the maxilla 12”) the upper tray (upper section 31) with respect to the lower tray (lower section 32), wherein the forces exerted by the second orthodontic elastic band (right side rearmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”) and the fourth orthodontic elastic band (left side rearmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”) control anterior-posterior movement of ([0027] teaches that the elastics 25 “exert forces that tend move the mandible 10 forward and upward with respect to the maxilla 12”) the upper tray (upper section 31) with respect to the lower tray (lower section 32), and wherein the forces (taught in [0027]) exerted by the first orthodontic elastic band (right side forwardmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”), the second orthodontic elastic band (right side rearmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”), the third orthodontic elastic band (left side forwardmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”), and the fourth orthodontic elastic band (left side rearmost elastic 25; [0038] teaches that Figure 8 illustrates “multiple elastics 25”) allow movement of the subject’s jaw ([0038] teaches that the configuration of elastics 25 “allows a greater range of motion”) while maintaining the upper tray (upper section 31) and lower tray (lower section 32) in a position which alleviates snoring and apnea in the subject ([0027] teaches that the elastics 25 “exert forces that tend move the mandible 10 forward and upward with respect to the maxilla 12;” [0012] teaches that the device functions “for treatment of sleep apnea and snoring”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the upper tray, lower tray and elastic bands of Tousssaint to include a first orthodontic elastic band connecting the right side fastener of the upper tray to the right side anterior fastener of the lower tray and a second orthodontic elastic band connecting the right side fastener of the upper tray to the right side posterior fastener of the lower tray; and a third orthodontic elastic band connecting the left side fastener of the upper tray to the left side anterior fastener of the lower tray and a fourth orthodontic elastic band connecting the left side fastener of the upper tray to the left side posterior fastener of the lower tray, and wherein the forces exerted by the first orthodontic elastic band and the third orthodontic elastic band control vertical positioning of the upper tray with respect to the lower tray, wherein the forces exerted by the second orthodontic elastic band and the fourth orthodontic elastic band control anterior-posterior movement of the upper tray with respect to the lower tray, and wherein the forces exerted by the first orthodontic elastic band, the second orthodontic elastic band, the third orthodontic elastic band, and the fourth orthodontic elastic band allow movement of the subject’s jaw while maintaining the upper tray and lower tray in a position which alleviates snoring and apnea in the subject as taught by Callender because this element is known to “change the angle of the force exerted by an elastic” as needed for a particular therapeutic regimen and “exert forces that tend move the mandible 10 forward and upward with respect to the maxilla 12,” as Callender teaches in [0027] and [0038].
Tousssaint and Callender do not teach wherein each of the first, second, third and fourth orthodontic elastic bands exerts a force of no more than 3 Newtons when placed under tension.
However, Singer, et al. teaches in [0055] an analogous device wherein each of the first, second, third and fourth orthodontic elastic bands (elastomeric ligature connectors 12; Figure 1 teaches four elastomeric ligature connectors 12) exerts a force of no more than 3 Newtons when placed under tension ([0055] teaches “the elastomeric ligature connectors 12 can be 3/8 inch or 1/4 inch non-latex elastics with some of the elastics having a medium force of four ounces and some of the elastics having a heavier force of six ounces;” when converted 4 ounces equals 1.11 Newtons and 6 ounces equals 1.67 Newtons).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first, second, third and fourth orthodontic elastic bands of Tousssaint as modified by Callender such that each of the first, second, third and fourth orthodontic elastic bands exerts a force of no more than 3 Newtons when placed under tension as taught by Singer, et al. because this element is known to provide force-extension characteristics that are most suitable for the desired jaw alignment.
In regards to claim 2, Tousssaint, Callender and Singer, et al. teach the apparatus of claim 1. Tousssaint and Callender do not disclose wherein each of the first, second, third and fourth orthodontic elastic bands exert a force of between 0.9 Newton and 3 Newtons when placed under tension.
However, Singer, et al. further teaches wherein each of the first, second, third and fourth orthodontic elastic bands (elastomeric ligature connectors 12; Figure 1 teaches four elastomeric ligature connectors 12) exert a force of between 0.9 Newton and 3 Newtons when placed under tension (elastomeric ligature connectors 12 can have a medium force of 4 ounces or a heavier force of 6 ounces, p. [0055]; when converted 4 ounces equals 1.11 Newtons and 6 ounces equals 1.67 Newtons) providing an elastic band that is high flexibility with a greater ability to return to the original dimension while also providing force-extension characteristics that are most suitable for the desired jaw alignment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the first, second, third and fourth orthodontic elastic bands as disclosed by Tousssaint as modified by Callender and Singer, et al. to exert a force of between 0.9 Newton and 3 Newtons when placed under tension as further taught by Singer, et al. in order to provide elastic bands that are high flexibility with a greater ability to return to the original dimension while also providing force-extension characteristics that are most suitable for the desired jaw alignment.
In regards to claim 3, Tousssaint, Callender and Singer, et al. teach the apparatus of claims 1 and 2. Tousssaint and Callender do not disclose wherein each of the first, second, third and fourth orthodontic elastic bands exert a force of between 1.4 Newtons and 2.4 Newtons when placed under tension.
However, Singer, et al. further teaches wherein each of the first, second, third and fourth orthodontic elastic bands (elastomeric ligature connectors 12; Figure 1 teaches four elastomeric ligature connectors 12) exert a force of between 1.4 Newtons and 2.4 Newtons when placed under tension (elastomeric ligature connectors 12 can have a medium force of 4 ounces or a heavier force of 6 ounces, p. [0055]; when converted 4 ounces equals 1.11 Newtons and 6 ounces equals 1.67 Newtons) providing an elastic band that is high flexibility with a greater ability to return to the original dimension while also providing force-extension characteristics that are most suitable for the desired jaw alignment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the first, second, third and fourth orthodontic elastic bands as disclosed by Tousssaint as modified by Callender and Singer, et al. to exert a force of between 1.4 Newtons and 2.4 Newtons when placed under tension as further taught by Singer, et al. in order to provide elastic bands that are high flexibility with a greater ability to return to the original dimension while also providing force-extension characteristics that are most suitable for the desired jaw alignment.
In regards to claim 4, Tousssaint, Callender and Singer, et al. teach the apparatus of claim 1. Tousssaint and Callender do not disclose wherein the width of each of the first, second, third and fourth orthodontic elastic bands is between 4.8 mm and 7.9 mm.
However, Singer, et al. further teaches wherein the width of each of the first, second, third and fourth orthodontic elastic bands (elastomeric ligature connectors 12; Figure 1 teaches four elastomeric ligature connectors 12) is between 4.8 mm and 7.9 mm (elastomeric ligature connectors 12 can be ¼ inch, p. [0055]; when converted ¼ inch equals 6.35mm) providing an elastic band that is sized to provide high flexibility with a greater ability to return to the original dimension while also providing force-extension characteristics that are most suitable for the desired jaw alignment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the first, second, third and fourth orthodontic elastic bands as disclosed by Tousssaint as modified by Callender and Singer, et al. to have the width of the elastic bands between 4.8 mm and 7.9 mm as further taught by Singer, et al. in order to provide elastic bands that are sized to provide high flexibility with a greater ability to return to the original dimension while also providing force-extension characteristics that are most suitable for the desired jaw alignment.
In regards to claim 5, Tousssaint, Callender and Singer, et al. teach the apparatus of claim 1. Tousssaint further discloses wherein the left side fastener of the upper tray is positioned laterally of the portion of the receptacle formed in the lower surface and adapted to retain the left maxillary first bicuspid (left side front fixing knob 5a is positioned laterally from the outer surface of and the inside bottom 12 of the upper tray which would correspond to the left maxillary first bicuspid when worn by the user, Fig 8, p. [0042, 0044]) and the right side fastener of the upper tray is positioned laterally of the portion of the receptacle formed in the lower surface and adapted to retain the right maxillary first bicuspid (right side front fixing knob 5b is positioned laterally from the outer surface of and the inside bottom 12 of the upper tray which would correspond to the right maxillary first bicuspid when worn by the user, Fig 8, p. [0042, 0044]).
In regards to claim 6, Tousssaint, Callender and Singer, et al. teach the apparatus of claim 1. Tousssaint further discloses wherein the left side anterior fastener of the lower tray is positioned laterally of the portion of the receptacle formed in the lower surface and adapted to retain the left mandibular first bicuspid (left side front fixing knob 7a is positioned laterally from the outer surface of and the inside bottom 12 of the lower tray which would correspond to the left mandibular first bicuspid when worn by the user, Fig 8, p. [0042, 0044]) and the right side anterior fastener of the lower tray is positioned laterally of the portion of the receptacle formed in the lower surface and adapted to retain the right mandibular first bicuspid (right side front fixing knob 7b is positioned laterally from the outer surface of and the inside bottom 12 of the lower tray which would correspond to the right mandibular first bicuspid when worn by the user, Fig 8, p. [0042, 0044]).
In regards to claim 17, Tousssaint discloses a method of treating snoring or sleep apnea in a subject (general purpose two part mandibular protrusion splint for the prevention of snoring and/or obstructive sleep apnea, p. [0012-0014]), comprising the step of providing a sleep apneal oral appliance (see the rejection of claim 1 above) to the subject (inherent to the use of Toussaint’s appliance for the treatment of sleep apnea and snoring, p. [0014] describes steps for producing and using the device, p. [0012-0014]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tousssaint (US 2011/0155144 A1), in view of Callender (US 2009/0036889 A1), in view of Singer, et al. (US 2013/0295517 A1) and further in view of Bailey (US 7,637,262 B2).
In regards to claim 11, Tousssaint, Callender and Singer, et al. teach the apparatus of claim 1. Tousssaint, Callender and Singer, et al. do not disclose wherein the upper surface of the right side of the lower tray comprises a right side bite surface and the upper surface of the left side of the lower tray comprises a left side bite surface, wherein the right and left side bite surfaces are horizontal and are each disposed vertically higher than other portions of the upper surface of the lower tray, such that the lower surface of the upper tray contacts the right side and left side bite surfaces when the upper tray is placed in contact with the lower tray.
However, Bailey teaches an analogous oral appliance (anti-retrusion oral appliance for treating sleep apnea and bruxism, title, abstract) wherein the analogous upper surface of the analogous right side of the analogous lower tray (lower tray component 14 has a right side that covers the right side of the mandible and an “upper surface” that is located opposite the surface that contacts and retains the lower teeth, additionally the upper surface of the lower tray component 14 comes into contact with the lower surface of the upper tray component 12, Figs 1 and 3, col 4 lines 22-32 and 58-58) comprises a right side bite surface (right side lower bite pad 30, see Fig 1, col 5 lines 54-62) and the analogous upper surface of the analogous left side of the analogous lower tray (lower tray component 14 has a left side that covers the left side of the mandible and an “upper surface” that is located opposite the surface that contacts and retains the lower teeth, additionally the upper surface of the lower tray component 14 comes into contact with the lower surface of the upper tray component 12, Figs 1 and 3, col 4 lines 22-32 and 58-58) comprises a left side bite surface (left side lower bite pad 30, see Fig 1, col 5 lines 54-62), wherein the right and left side bite surfaces are horizontal (left and right lower bite pads 30 each have a smooth faced pad 56 having uniform flat contact faces 60, 62, Fig 1, col 8 lines 27-53) and are each disposed vertically higher than other portions of the upper surface of the lower tray (left and right side lower bite pads 30 have an inclined region 32 which disposes flat contact surface 62 vertically higher than flat contact surface 60, see Figs 1 and 3, col 6 lines 1-42, col 8 lines 27-54), such that the analogous lower surface of the analogous upper tray contacts the right side and left side bite surfaces when the upper tray is placed in contact with the lower tray (the bite pads 28 on the lower surface of the upper tray component 12 contacts the bite pads 30 on the upper surface of the lower tray component, see Fig 3, col 5 lines 63-67, col 6 lines 1-10) providing support to the user’s airway by having opposed upper and lower bite pads at differing vertical heights so as to prevent bypassing posterior movement thus preventing the mandible and tongue from falling back and collapsing the airway (Bailey, col 5 lines 54-67, col 6 lines 1-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the upper surface of the lower tray as disclosed by Tousssaint as modified by Callender and Singer, et al. to have wherein the upper surface of the right side of the lower tray comprises a right side bite surface and the upper surface of the left side of the lower tray comprises a left side bite surface, wherein the right and left side bite surfaces are horizontal and are each disposed vertically higher than other portions of the upper surface of the lower tray, such that the lower surface of the upper tray contacts the right side and left side bite surfaces when the upper tray is placed in contact with the lower tray as taught by Bailey in order to provide support to the user’s airway by having opposed upper and lower bite pads at differing vertical heights so as to prevent bypassing posterior movement thus preventing the mandible and tongue from falling back and collapsing the airway (Bailey, col 5 lines 54-67, col 6 lines 1-10).
Conclusion
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 1/15/2026