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 .
Response to Amendment
This Office Action is responding to applicant’s amendment filed on 3/10/2026. Claims 1, 5, 11, and 16 have been amended.
Response to Arguments
The LeBlanc reference has been withdrawn in view of applicant’s amendment. The claims, as amended, have been carefully considered and deemed not allowable in view of Fallon reference, as presented below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 8-11, 14-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fallon (U.S. Patent No. US 8,833,374).
Regarding independent claim 1, Figures 1-10 discloses applicant’s claimed mandibular advancement device (1), comprising:
an upper tray assembly (3), arch-shaped and configured to conform to a curvature of an
upper dental arch of a user (see Figure 1);
a lower tray assembly (5) spaced (Figure 9) from the upper tray assembly (5) is a first direction (vertical), arch-shaped and configured to conform to a curvature of a lower dental arch of the user (see Figure 1);
wherein the upper tray assembly (3) comprises an upper frame (9) and an upper moldable
component (7);
wherein the lower tray assembly (5) comprises a lower frame (10) and a lower moldable
component (12);
wherein the upper tray assembly (3) and the lower tray assembly (5) includes at least two
different materials (trays and impression trays); and
an adjustment part (30, 48) configured to connect the upper tray assembly (3) and the lower tray assembly (5) by a snap-fit (block 48 interference-fit within channel 30), and to adjust a position of the lower tray assembly (5) relative to the upper tray assembly (3);
wherein the snap-fit (interference fit) includes at least one protrusion (block 48) and at least one protrusion receiving part (channel 30) on one side of the upper tray assembly (3) and the lower tray assembly (5),
wherein the at least one protrusion (block 48) is configured to compressively connect the upper frame (9) and the lower frame (10),
wherein each of the at least one protrusion (block 48) and the at least one protrusion receiving part (channel 30) has a length in a second direction (anterior-posterior) and a width in a third direction (lateral-medial),
wherein the length of the at least one protrusion is less than the length of the at least one
protrusion receiving part (see Figures 9-10), and
wherein the at least one protrusion (block 48) and the at least one protrusion receiving part (channel 30) have sidewalls (32, 34, 50, 52) extending in the second direction (anterior-posterior), the sidewalls (32, 34, 50, 52) having interlocking nonplanar surfaces (teeth surfaces 32, 50) to prevent movement of the at least one protrusion (block 48) in the second direction (anterior-posterior).
Regarding claim 2, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 1, wherein the
upper tray assembly (3) is configured to contact the upper dental arch of the user (see Figure 1).
Regarding claim 3, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 1, wherein the
lower tray assembly (5) is configured to contact the lower dental arch of the user (see Figure 1).
Regarding claim 4, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 1, wherein the
upper moldable component (7) is configured to soften upon heating to allow it to be adjusted and
molded into a shape to match the upper dental arch when the user bites down (column 3 lines 59-62).
Regarding claim 5, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 1, wherein the
lower moldable component is configured to soften upon heating to allow it to be adjusted and
molded into a shape to match the lower dental arch when the user bites down (column 4 lines 7-8).
Regarding claim 6, Figures 1-10 discloses applicant’s claimed mandibular advancement device (1), comprising:
an upper tray assembly (3) comprising an upper frame (9) and an upper moldable component (7);
a lower tray assembly (5) comprising a lower frame (10) and a lower moldable component (12);
wherein the upper tray assembly (3) and the lower tray assembly (5) includes at least two
different materials (trays 9, 10 and impression trays 7, 12); and
an adjustment part (30, 48) configured to connect the upper tray assembly (3) and the lower tray assembly (5) by a snap-fit (block 48 interference-fit within channel 30), and to adjust a position of the lower tray assembly (3) relative to the upper tray assembly (5) between a first predetermined position and a second predetermined position;
wherein the snap-fit (interference fit 30, 48) includes at least one protrusion (block 48) and at least one protrusion receiving part (channel 30) on one side of the upper tray assembly (3) and the lower tray assembly (5),
wherein the at least one protrusion (block 48) is configured to compressively connect the upper frame (9) and the lower frame (10);
wherein the upper frame (9) and the lower frame (10) each have at least one inner wall and at least one outer wall (see upper frame 9 in Figures 7 and lower frame 10 in Figure 8)
wherein the at least one protrusion (block 48) has a first position in the at least one protrusion receiving part (channel 30) when the lower tray assembly (5) is in the first position relative to the upper tray assembly (3),
wherein the at least one protrusion (block 48) has a second position in the at least one protrusion receiving part (channel 30) when the lower tray assembly (5) is in the second position relative to the upper tray assembly (3),
wherein a sidewall (50, 52) of the at least one protrusion (block 48) has at least one protruding edge (see Figure 9) and a sidewall (32, 34) of the at least one protrusion receiving part (32) has at least one recessed edge (see Figure 10, and
wherein the at least one protruding edge (50, 52) and the at least one recessed edge (32, 34) retain the at least one protrusion (block 48) in the first position or the second position (column 9 lines 3-18 describes the block 48 moves relative to channel in anterior-posterior direction upon selectively engaging teeth 32, 50).
Regarding claim 8, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 6, wherein the upper frame (9) and the lower frame (10) each have at least one bottom wall (occlusal surface), the at least one protrusion (block 48) is provided on the surface of the at least one bottom wall of the lower frame (10), and the at least one protrusion receiving part (channel 30) is provided on the surface of the at least one bottom wall of the upper frame (9), and is opposite the at least one protrusion (block 48).
Regarding claim 9, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 6, wherein the upper moldable component (7) and the lower moldable component (12) include a flexible thermoplastic material (column 3 lines 59-62).
Regarding claim 10, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 6, wherein the upper frame (9) and the lower frame (10) include a relatively rigid material () (column 3 lines 59-63) compared to the upper moldable component (7) and lower moldable component (12).
Regarding independent claim 11, Figures 1-10 discloses applicant’s claimed mandibular advancement device (1), comprising:
an upper tray assembly (3) comprising an upper frame (9) and an upper moldable component (7);
a lower tray assembly (5) comprising a lower frame (10) and a lower moldable component (12);
wherein the upper tray assembly (3) and the lower tray assembly (5) includes at least two
different materials (trays 9, 10 and impression trays 7, 12) and the lower tray assembly (5) is spaced from the upper tray assembly (5) in a first direction (vertical); and
an adjustment part (block 48 and channel 30) configured to connect the upper tray assembly (3) and the lower tray assembly (5) by a snap-fit (block 48 interference-fit within channel 30), and to adjust a position of the lower tray assembly (5) relative to the upper tray assembly (3);
wherein the upper frame (9) and the lower frame (10) each have at least one inner wall (see upper frame 9 in Figure 7 and lower frame 10 in Figure 8),
wherein the adjustment part (block 48 and channel 30) includes at least one protrusion (block 48) and at least one protrusion receiving part (channel 30) on one side of the upper tray assembly (3) and the lower tray assembly (5),
wherein the at least one protrusion (block 48) has a first position in the at least one protrusion receiving part (channel 30) when the lower tray assembly (5) is in the first position relative to the upper tray assembly (3),
wherein the at least one protrusion (block 48) has a second position in the at least one protrusion receiving part (channel 30) when the lower tray assembly (3) is in the second position relative to the upper tray assembly (3),
wherein the at least one protrusion (block 48) and the at least one protrusion receiving part (channel 30) retain the at least one protrusion (block 48) in the first position or the second position,
wherein each of the at least one protrusion (block 48) and the at least one protrusion receiving part (channel 30) has a length in a second direction (anterior-posterior direction) and a width in a third direction (medial-lateral direction),
wherein the length of the at least one protrusion (block 48) is less than the length of the at least one protrusion receiving part (channel 30), and
wherein the at least one protrusion (block 48) and the at least one protrusion receiving part (channel 30) have sidewalls (32, 34, 50, 52) extending in the second direction (anterior-posterior direction), the sidewalls (32, 34, 50, 52) having interlocking nonplanar surfaces (teeth 32, 50) to prevent movement of the at least one protrusion in the second direction (column 9 lines 3-18 describes the block 48 moves relative to channel in anterior-posterior direction upon selectively engaging teeth 32, 50).
Regarding claim 14, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 11, comprising all features as recited in these claims, wherein the snap-fit (block 48 interference-fit within channel 30) of the adjustment part (30, 48) is configured in I-shaped (Figures 7 & 9 illustrate protrusion 48 is a column-like shape which is in I-shaped).
Regarding claim 15, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 11, wherein the adjustment part is configured to adjust multiple positions (teeth 32, 50 indicate multiple positions).
Regarding independent claim 16, Figures 1-10 discloses applicant’s claimed mandibular advancement device (1), comprising:
an upper tray assembly (3) comprising an upper frame (9) and an upper moldable component (7);
a lower tray assembly (5) comprising a lower frame (10) and a lower moldable component (12);
wherein the lower tray assembly (3) spaced from the upper tray assembly (5) is a first direction (vertical direction);
wherein the upper tray assembly (3) and the lower tray assembly (5) includes at least two
different materials (trays 9, 10 and impression trays 7, 12); and
an adjustment part (block 48 and channel 30) configured to connect the upper tray assembly (3) and the lower tray assembly (5) by a snap-fit (block 48 interference-fit within channel 30), and to adjust a position of the lower tray assembly (5) relative to the upper tray assembly (3);
wherein the upper frame (9) and the lower frame (10) each have a left side, a right side, at least one inner wall, at least one outer wall, and at least one bottom wall (see Figures 7-8); and
wherein a vertical distance between the at least one inner wall, the at least one outer wall,
and the at least one bottom wall between 0.5 mm to 20 mm;
wherein the adjustment part (block 48 and channel 30) includes at least one protrusion (block 48) and at least one protrusion receiving part (channel 30) on one side of the upper tray assembly (3) and the lower tray assembly (5),
wherein the at least one protrusion (block 48) has a first predetermined position in the at least one protrusion receiving part (channel 30) when the lower tray assembly (5) is in the first position relative to the upper tray assembly (3),
wherein the at least one protrusion (block 48) has a second predetermined position in the at least one protrusion receiving part (channel 30) when the lower tray assembly (5) is in the second position relative to the upper tray assembly (3),
wherein the at least one protrusion (block 48) and the at least one protrusion receiving part (channel 30) retain the at least one protrusion (block 48) in the first position or the second position,
wherein each of the at least one protrusion (block 48) and the at least one protrusion receiving part (channel 30) has a length in a second direction (anterior-posterior direction) and a width in a third direction (medial-lateral direction),
wherein the length of the at least one protrusion (block 48) is less than the length of the at least one protrusion receiving part (channel 30), and
wherein the at least one protrusion (block 48) and the at least one protrusion receiving part (channel 30) prevent movement of the at least one protrusion (block 48) in the second direction (column 9 lines 3-18 describes the block 48 moves relative to channel in anterior-posterior direction upon selectively engaging teeth 32, 50).
Regarding claim 18, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 16, wherein the upper tray assembly (3) includes at least one channel pillar (26), and
when the upper tray assembly is combined with the lower tray assembly, gaps (28) between the upper tray assembly and the lower tray assembly and the at least one channel pillar (26) jointly form at least one airflow channel (76).
Regarding claim 19, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 16, wherein a number of the at least one channel pillar is odd (one pillar 26 constitute an odd number).
Regarding claim 20, Fallen reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 16, wherein a number of the at least one airflow channel (76) is even and a structure of the at least one airflow channel is symmetrical.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fallon (U.S. Patent No. 8,833,374).
Regarding claim 7, Fallon reference, presented above, discloses applicant’s claimed mandibular advancement device according to claim 6, including upper/lower frames (9, 10) each has a bottom wall (occlusal floor surface), the at least one protrusion (block 48) and the at least one protrusion receiving part (channel 30).
Fallon does not specifically disclose the at least one protrusion (block 48) is provided on a surface of the at least one bottom wall of the upper frame, and the at least one protrusion receiving part is provided on a surface of the at least one bottom wall of the lower frame, and is opposite the at least one protrusion.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made prior to applicant’s effective filing to rearrange the block 48 and channel 30 such that the block 48 is on bottom surface of upper frame and channel 30 is on bottom wall of lower frame, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Fallon (U.S. Patent No. 8,833,374), in view of Scarberry (U.S. Patent Application Publication No. US 2007/0292819).
Regarding claims 12-13, Fallon reference, presented above, discloses applicant’s claimed mandibular advancement device (1, Fallon) comprising an upper frame (9, Fallon) and a lower frame (10, Fallon).
Fallon does not disclose a total weight of the upper frame and the lower frame is between 3 g to 50 g and does not disclose a total weight of the mandibular advancement device is between 8 g to 80 g.
However, Scarberry teaches an analogous mandibular advancement device comprising a lower tray (41) and an upper tray (11), paragraph 0056 teaches the upper tray (11) having a material of polycarbonate resin material (LEXAN) which is the same material as Fenton’s (column 5 lines 13-25, Fenton) and paragraph 0056 further teaches the upper tray (11) having a weight of .0076 lbs (3.45 g), such that total weight of both upper tray and lower tray deems 6.9 g.
Therefore, it would have been obvious to one of ordinary skill in the art prior to applicant’s effective filing date to construct Fallon’s mandibular advancement device such that total weight of 6.9 g for lower & upper trays deems reasonable and feasible to don on the arches of teeth without compromising burden on the mandible/maxillary.
With respect applicant’s claimed total weight of mandibular advancement device, it would have been obvious for one of ordinary skill in the art to see that the total weight of the mandibular advancement device which also includes the weight of the moldable materials on the lower and upper frames, which necessarily falls between 8g-80g.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Fallon (U.S. Patent No. 8,833,374), in view of Hiro (U.S. Patent No. 5,666,974).
Regarding claim 17, Fallon reference, presented above, discloses applicant’s claimed mandibular advancement device (1, Fallon) comprising all features as recited in these claims.
Fallon does not disclose a thickness of the at least one bottom wall of the upper frame and the lower frame is between 0.5 mm to 20 mm.
However, Hiro teaches an analogous mouth piece comprising an outer wall (1), an inner wall (3) and a bottom wall (2), column 2 lines 54-65 teaches vertical distance between inner wall (3) and bottom wall (2) is in the range of 3.5 - 8 mm and vertical distance between outer wall (1) and bottom wall (2) is in the range of 5.0 - 15 mm and thickness of bottom wall (2) is 0.5 - 2.0 mm.
Therefore, it would have been obvious to one of ordinary skill in the art prior to applicant’s effective filing date to construct Fallon’s mandibular advancement device to have vertical height and thickness taught by Hiro, as such dimensions provide comfort to the wearer.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CAMTU T NGUYEN/Examiner, Art Unit 3786