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
The amendments made to claims 1, 6, 11, and 17 and the cancellation of claims 13-16 in the response filed 6/3/26 are acknowledged.
Claims 1-9, 11, 12, and 17-20 are now pending in the application and are examined below.
Response to Arguments
Applicant's arguments filed 6/3/26 have been fully considered but they are not persuasive. Applicant argues on p. 11-12 that the structure of protrusions formed by overflowing material and cooling is distinct from pre-formed protrusions disclosed by Fallon, because the protrusions are not compressed by the holes and the material has the opportunity to bond to the surface of the slots. However, Applicant has not provided any evidence that this would be the case. Applicant can alternatively claim these features of the protrusions (bonded to the surface of the slots, etc.) given adequate support in the specification. Applicant’s arguments on p. 12 that the prior art of record fails to disclose or teach the newly added limitations is unpersuasive, as the teeth 50 and 32 of Fallon have been interpreted to address these limitations (please see body of rejection below).
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 1-9, 11, 12, and 17-20 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.
Regarding claim 1, the claim recites the limitation “the upper moldable surface” in line 31. There is insufficient antecedent basis for this limitation in the claim.
The claim further recites the limitation “the moldable component” in lines 32-33. It is unclear which of the upper and lower moldable components is being referred to. Therefore, the scope of the claim is unclear.
Regarding claim 6, the claim recites the limitation “the upper moldable surface” in line 29. There is insufficient antecedent basis for this limitation in the claim.
The claim further recites the limitation “the moldable component” in line 31. It is unclear which of the upper and lower moldable components is being referred to. Therefore, the scope of the claim is unclear.
Regarding claim 11, the claim recites the limitation “the upper moldable surface” in line 25. There is insufficient antecedent basis for this limitation in the claim.
The claim further recites the limitation “the moldable component” in line 26. It is unclear which of the upper and lower moldable components is being referred to. Therefore, the scope of the claim is unclear.
Regarding claim 17, the claim recites the limitation “the upper moldable surface” in line 26. There is insufficient antecedent basis for this limitation in the claim.
The claim further recites the limitation “the moldable component” in line 28. It is unclear which of the upper and lower moldable components is being referred to. Therefore, the scope of the claim is unclear.
Regarding claims 2-5, 7-9, 12, and 18-20, the claims are rejected under 35 U.S.C. 112(b) by virtue of their dependence on claims 1, 6, 11, and 17.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-5, 11, 12, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallon et al. US 2012/0145166 A1 in view of Altieri US 2,827,899 further in view of Thornton et al. US 2014/0053852 A1.
Regarding claim 1, Fallon discloses an oral appliance 1 (fig. 8 and abstract, intraoral mandibular advancement device), comprising:
an upper tray assembly 7/9 configured to be positioned within a user’s oral cavity adjacent to a user’s upper dental arch (fig. 8 and [0023], upper chassis 9 and upper tray 7 form the upper tray assembly 7/9);
a lower tray assembly 10/12 configured to be positioned within the user’s oral cavity adjacent to a user’s lower dental arch (fig. 8 and [0023], lower chassis 10 and lower tray 12 form the upper tray assembly 10/12);
wherein the upper tray assembly 7/9 includes an upper moldable component 7 and an upper frame 9 stacked in a first direction ([0022], upper bite impression tray 7 is made from soft impressionable material, and upper chassis 9 is made from relatively hard and rigid material; fig. 7, the elements are stacked in the vertical direction as shown);
wherein the lower tray assembly 10/12 includes a lower moldable component 12 and a lower frame 10 stacked in the first direction ([0023], lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material; fig. 7, the elements are stacked in the vertical direction as shown);
the upper moldable component 7 and the lower moldable component 12 including a moldable material that can deform when heated, and the upper frame 9 and the lower frame 10 do not deform when heated to a temperature required for deforming the upper moldable component 7 and the lower moldable component 12 ([0022]-[0023], the moldable material is EVA; as evidenced by Brett et al. US 6,584,978 B1 in col. 1, lines 49-53, EVA has a softening point at approximately the temp of boiling water; [0045], the appliance 1 is warmed in boiling water so that the patient can bite into the moldable trays 7 and 9, which is compressed against the relatively hard upper and lower chassis 9 and 10, indicating that the chassis 9/10 have a deformation temperature greater than 100 degrees Celsius since they did not soften at the same temperature as the EVA);
wherein the upper moldable component 7 is configured to be detachably connectable to an upper surface of the upper frame 9 (fig. 8 and [0025]-[0026], upper tray 7 is coupled to the upper surface of frame 9 via protrusions 16/18 that fit into openings 20/22; thus, tray 7 would be capable of detaching from frame 9 by removing the protrusions from the openings);
wherein the lower moldable component 12 is configured to be detachably connectable to a lower surface of the lower frame 10 (fig. 7 and [0030]-[0031], lower tray 12 is coupled to the lower surface of frame 10 via protrusions 38/40 that fit into openings 42/44; thus, tray 12 would be capable of detaching from frame 10 by removing the protrusions from the openings);
wherein the upper moldable component 7 and the lower moldable component 12 each have at least one outer wall (figs. 4 and 6, the outer walls of trays 7 and 12 being the outer surfaces facing the inner surface of their respective receiving frames 9 and 10);
wherein the upper frame 9 and the lower frame 10 have at least one inner wall (figs. 4 and 6, the inner walls of frames 9 and 10 being the inner surfaces that face trays 7 and 12);
wherein the at least one outer wall of the upper moldable component 7 and the at least one outer wall of the lower moldable component 12 are each at least partially in contact with the at least one inner wall of the upper frame 9 and the at least one inner wall of the lower frame 10, respectively (figs. 4 and 6, the outer walls of trays 7 and 12 being the outer surfaces facing and directly contacting the inner surface/wall of their respective receiving frames 9 and 10),
wherein second protrusions 50/32 are formed on an upper surface of a central part of the lower moldable component 12 and a lower surface of a central part of the upper moldable component 7 (fig. 7 and [0034], teeth 50 of adjustment blocks 48 are formed on and supported by the upper surface of the central part of the lower moldable component 12 (i.e., any part of the moldable component 12 within its outer perimeter being interpreted as the central part), since the lower frame 10 is on and supported by lower moldable component 12; similarly, fig. 8, teeth 32 of channels 30 are formed on an supported by the lower surface of the central part of the upper moldable component 7 (i.e., any part of the moldable component 7 within its outer perimeter being interpreted as the central part), since the upper frame 9 is held on the upper moldable component 7; please note the claims do not require the protrusions to be formed directly on the respective upper and lower surfaces), the at least one second protrusion 50 of the lower moldable component 12 contacting the at least one second protrusion 3 of the moldable component 7 (figs. 7 and 8 and [0034], the teeth 50 mesh against teeth 32).
Fallon is silent on wherein, during a shaping process, the upper moldable component is connected to the upper frame by first protrusions formed by overflowing material of the upper moldable component when heated and then cooled, wherein, during the shaping process, the lower moldable component is connected to the lower frame by first protrusions formed by overflowing material of the lower moldable component when heated and then cooled.
However, Altieri teaches a mouthguard (fig. 1 and col. 1, lines 15-18), wherein, during a shaping process, an analogous moldable component 11 is connected to a frame 13 by first protrusions formed by overflowing material of the moldable component when heated and then cooled (figs. and col. 4, lines 19-26, where rubber material of primary body 11 flows through perforations 40 in reinforcing member 13 to secure the two elements together; however, please note that the protrusions being formed by the overflowing material when heated and cooled is a product by process limitation, since Altieri teaches the protrusions being made of the same material as and being continuous from the moldable component (the final product), regardless of how the forming was completed; please see MPEP 2113; in other words, while the claim limitations do distinguish over Fallon, since Fallon does not disclose the protrusions 16/18/38/40 necessarily being made of the same material and being continuous from the moldable components (which is structurally what these limitations would result in), Altieri does not have to teach the overflowing material being heated and cooled to form the protrusions).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper moldable component/upper frame and lower moldable component/lower frame of Fallon such that during a shaping process, the upper moldable component is connected to the upper frame by first protrusions formed by overflowing material of the upper moldable component when heated and then cooled, wherein, during the shaping process, the lower moldable component is connected to the lower frame by first protrusions formed by overflowing material of the lower moldable component when heated and then cooled, as taught by Altieri, to ensure a strong and secure connection between each moldable component and their respective frames.
Fallon in view of Altieri is silent on wherein ends of the upper moldable component extend beyond ends of the upper frame in a second direction perpendicular to the first direction, and wherein the ends of the upper moldable component and the ends of the upper frame form a stepped shape.
However, Thornton teaches an oral appliance (fig. 4 and [0077], dental device) wherein ends of an analogous upper moldable component 135 extend beyond ends of an analogous upper frame 100 in a second direction perpendicular to the first direction (fig. 4 and [0077], moldable tray 135 and arched frame 100; as can particularly be seen in the figure, the left rear tip of frame 100 terminates short of the moldable tray 135, such that the tray 135 extends beyond the end in the anterior-posterior direction, which is perpendicular to the first up-down direction; though fig. 4 does not show the right rear tip, fig. 3C shows that at both rear ends, the tray 135 extends past the ends of the frame 100), and wherein the ends of the upper moldable component 135 and the ends of the upper frame 100 form a stepped shape (fig. 4 shows the ends of the tray 135 and frame 100 forming a stepped shape, as the frame 100 ends abruptly short of the end of the tray 135).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the oral appliance of Fallon in view of Altieri such that ends of the upper moldable component extend beyond ends of the upper frame in a second direction perpendicular to the first direction, and wherein the ends of the upper moldable component and the ends of the upper frame form a stepped shape, as taught by Thornton, so that the more rigid frame material does not contact the rear tissues of the mouth, preventing discomfort.
Regarding claim 2, Fallon in view of Altieri further in view of Thornton discloses the claimed invention as discussed above.
Fallon further discloses a shape of the upper tray assembly 7/9 being configured to conform to a curvature of the user’s upper dental arch (fig. 8 and [0023], upper chassis 9 and upper tray 7 form the upper tray assembly 7/9, which is shown having an arcuate shape that is capable of conforming to the upper dental arch curve of a patient).
Regarding claim 3, Fallon in view of Altieri further in view of Thornton discloses the claimed invention as discussed above.
Fallon further discloses a shape of the lower tray assembly 10/12 being configured to conform to a curvature of the user’s lower dental arch (fig. 8 and [0023], lower chassis 10 and lower tray 12 form the upper tray assembly 10/12, which is shown having an arcuate shape that is capable of conforming to the lower dental arch curve of a patient).
Regarding claim 4, Fallon in view of Altieri further in view of Thornton discloses the claimed invention as discussed above.
Fallon further discloses the upper moldable component 7 and the lower moldable component 12 including a flexible thermoplastic material ([0022]-[0023], EVA).
Regarding claim 5, Fallon in view of Altieri further in view of Thornton discloses the claimed invention as discussed above.
Fallon further discloses the upper frame 9 and the lower frame 10 at least partially including a material that is relatively more rigid compared to the upper moldable component 7 and the lower moldable component 12 ([0022], upper bite impression tray 7 is made from soft impressionable material, and upper chassis 9 is made from relatively hard and rigid material; [0023], lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material).
Regarding claim 11, Fallon discloses an oral appliance 1 (fig. 8 and abstract, intraoral mandibular advancement device), comprising:
an upper tray assembly 7/9 configured to be positioned within a user’s oral cavity adjacent to a user’s upper dental arch (fig. 8 and [0023], upper chassis 9 and upper tray 7 form the upper tray assembly 7/9);
a lower tray assembly 10/12 configured to be positioned within the user’s oral cavity adjacent to a user’s lower dental arch (fig. 8 and [0023], lower chassis 10 and lower tray 12 form the upper tray assembly 10/12);
wherein the upper tray assembly 7/9 includes an upper moldable component 7 and an upper frame 9 stacked in a first direction ([0022], upper bite impression tray 7 is made from soft impressionable material, and upper chassis 9 is made from relatively hard and rigid material; fig. 7, the elements are stacked in the vertical direction as shown);
wherein the lower tray assembly 10/12 includes a lower moldable component 12 and a lower frame 10 stacked in the first direction ([0023], lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material; fig. 7, the elements are stacked in the vertical direction as shown);
wherein the upper tray assembly 7/9 and/or the lower tray assembly 10/12 include a connection part 16/20 and 38/42 configured to connect the upper moldable component 7 and the lower moldable component 12 to the upper frame 9 and the lower frame 10, respectively (fig. 8 and [0025]-[0026], upper tray 7 is coupled to frame 9 via protrusions 16 that fit into openings 20; fig. 7 and [0030]-[0031], lower tray 12 is coupled to frame 10 via protrusions 38 that fit into openings 42);
the upper moldable component 7 and the lower moldable component 12 including a moldable material that can deform when heated, and the upper frame 9 and the lower frame 10 do not deform when heated to a temperature required for deforming the upper moldable component 7 and the lower moldable component 12 ([0022]-[0023], the moldable material is EVA; as evidenced by Brett et al. US 6,584,978 B1 in col. 1, lines 49-53, EVA has a softening point at approximately the temp of boiling water; [0045], the appliance 1 is warmed in boiling water so that the patient can bite into the moldable trays 7 and 9, which is compressed against the relatively hard upper and lower chassis 9 and 10, indicating that the chassis 9/10 have a deformation temperature greater than 100 degrees Celsius since they did not soften at the same temperature as the EVA);
wherein the upper moldable component 7 is configured to be detachably connectable to an upper surface of the upper frame 9 (fig. 8 and [0025]-[0026], upper tray 7 is coupled to the upper surface of frame 9 via protrusions 16 that fit into openings 20; thus, tray 7 would be capable of detaching from frame 9 by removing the protrusions from the openings);
wherein the lower moldable component 12 is configured to be detachably connectable to a lower surface of the lower frame 10 (fig. 7 and [0030]-[0031], lower tray 12 is coupled to the lower surface of frame 10 via protrusions 38 that fit into openings 42; thus, tray 12 would be capable of detaching from frame 10 by removing the protrusions from the openings),
further comprising second protrusions 50/32 formed on an upper surface of a central part of the lower moldable component 12 and a lower surface of a central part of the upper moldable component 7 (fig. 7 and [0034], teeth 50 of adjustment blocks 48 are formed on and supported by the upper surface of the central part of the lower moldable component 12 (i.e., any part of the moldable component 12 within its outer perimeter being interpreted as the central part), since the lower frame 10 is on and supported by lower moldable component 12; similarly, fig. 8, teeth 32 of channels 30 are formed on an supported by the lower surface of the central part of the upper moldable component 7 (i.e., any part of the moldable component 7 within its outer perimeter being interpreted as the central part), since the upper frame 9 is held on the upper moldable component 7; please note the claims do not require the protrusions to be formed directly on the respective upper and lower surfaces), the at least one second protrusion 50 of the lower moldable component 12 contacting the at least one second protrusion 3 of the moldable component 7 (figs. 7 and 8 and [0034], the teeth 50 mesh against teeth 32).
Fallon is silent on wherein, during a shaping process, the connection part comprises first protrusions formed by overflowing material of the upper moldable component and the lower moldable component when heated and then cooled.
However, Altieri teaches a mouthguard (fig. 1 and col. 1, lines 15-18), wherein, during a shaping process, an analogous connection part comprises first protrusions formed by overflowing material of an analogous moldable component 11 when heated and then cooled (figs. and col. 4, lines 19-26, where rubber material of primary body 11 flows through perforations 40 in reinforcing member 13 to secure the two elements together; thus, the flow would create protrusions when passing through the perforations 40; however, please note that the protrusions being formed by the overflowing material when heated and cooled is a product by process limitation, since Altieri teaches the protrusions being made of the same material as and being continuous from the moldable component (the final product), regardless of how the forming was completed; please see MPEP 2113; in other words, while the claim limitations do distinguish over Fallon, since Fallon does not disclose the protrusions 16/18/38/40 necessarily being made of the same material and being continuous from the moldable components (which is structurally what these limitations would result in), Altieri does not have to teach the overflowing material being heated and cooled to form the protrusions).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the connection part of Fallon such that during a shaping process, the connection part comprises first protrusions formed by overflowing material of the upper moldable component and the lower moldable component when heated and then cooled, as taught by Altieri, to ensure a strong and secure connection between each moldable component and their respective frames.
Fallon in view of Altieri is silent on wherein ends of the upper moldable component extend beyond ends of the upper frame in a second direction perpendicular to the first direction, and wherein the ends of the upper moldable component and the ends of the upper frame form a stepped shape.
However, Thornton teaches an oral appliance (fig. 4 and [0077], dental device) wherein ends of an analogous upper moldable component 135 extend beyond ends of an analogous upper frame 100 in a second direction perpendicular to the first direction (fig. 4 and [0077], moldable tray 135 and arched frame 100; as can particularly be seen in the figure, the left rear tip of frame 100 terminates short of the moldable tray 135, such that the tray 135 extends beyond the end in the anterior-posterior direction, which is perpendicular to the first up-down direction; though fig. 4 does not show the right rear tip, fig. 3C shows that at both rear ends, the tray 135 extends past the ends of the frame 100), and wherein the ends of the upper moldable component 135 and the ends of the upper frame 100 form a stepped shape (fig. 4 shows the ends of the tray 135 and frame 100 forming a stepped shape, as the frame 100 ends abruptly short of the end of the tray 135).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the oral appliance of Fallon in view of Altieri such that ends of the upper moldable component extend beyond ends of the upper frame in a second direction perpendicular to the first direction, and wherein the ends of the upper moldable component and the ends of the upper frame form a stepped shape, as taught by Thornton, so that the more rigid frame material does not contact the rear tissues of the mouth, preventing discomfort.
Regarding claim 12, Fallon in view of Altieri further in view of Thornton discloses the claimed invention as discussed above.
Fallon further discloses the upper frame 9 and the lower frame 10 being detachably connectable to the upper moldable component 7 and the lower moldable component 12 respectively, via additional parts 18/22 and 40/44 configured to connect the upper moldable component 7 and the lower moldable component 12 to the upper frame 9 and the lower frame 10, respectively (fig. 8 and [0025]-[0026], upper tray 7 is coupled to frame 9 via additional protrusions 18 that fit into openings 22; fig. 7 and [0030]-[0031], lower tray 12 is coupled to frame 10 via additional protrusions 40 that fit into openings 44).
Regarding claim 17, Fallon discloses an oral appliance 1 (fig. 8 and abstract, intraoral mandibular advancement device), comprising:
an upper tray assembly 7/9 configured to be positioned within a user’s oral cavity adjacent to a user’s upper dental arch (fig. 8 and [0023], upper chassis 9 and upper tray 7 form the upper tray assembly 7/9);
a lower tray assembly 10/12 configured to be positioned within the user’s oral cavity adjacent to a user’s lower dental arch (fig. 8 and [0023], lower chassis 10 and lower tray 12 form the upper tray assembly 10/12);
wherein the upper tray assembly 7/9 includes an upper moldable component 7 and an upper frame 9 stacked in a first direction ([0022], upper bite impression tray 7 is made from soft impressionable material, and upper chassis 9 is made from relatively hard and rigid material; fig. 7, the elements are stacked in the vertical direction as shown);
wherein the lower tray assembly 10/12 includes a lower moldable component 12 and a lower frame 10 stacked in the first direction ([0023], lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material; fig. 7, the elements are stacked in the vertical direction as shown);
the upper moldable component 7 and the lower moldable component 12 including a moldable material that can deform when heated, and the upper frame 9 and the lower frame 10 do not deform when heated to a temperature required for deforming the upper moldable component 7 and the lower moldable component 12 ([0022]-[0023], the moldable material is EVA; as evidenced by Brett et al. US 6,584,978 B1 in col. 1, lines 49-53, EVA has a softening point at approximately the temp of boiling water; [0045], the appliance 1 is warmed in boiling water so that the patient can bite into the moldable trays 7 and 9, which is compressed against the relatively hard upper and lower chassis 9 and 10, indicating that the chassis 9/10 have a deformation temperature greater than 100 degrees Celsius since they did not soften at the same temperature as the EVA);
wherein the upper moldable component 7 is configured to be detachably connectable to an upper surface of the upper frame 9 (fig. 8 and [0025]-[0026], upper tray 7 is coupled to the upper surface of frame 9 via protrusions 16 that fit into openings 20; thus, tray 7 would be capable of detaching from frame 9 by removing the protrusions from the openings);
wherein the lower moldable component 12 is configured to be detachably connectable to a lower surface the lower frame 10 (fig. 7 and [0030]-[0031], lower tray 12 is coupled to the lower surface of frame 10 via protrusions 38 that fit into openings 42; thus, tray 12 would be capable of detaching from frame 10 by removing the protrusions from the openings);
and wherein the upper frame 9 and/or the lower frame 10 have at least one slot (figs. 3 and 5, the upper frame 9 and lower frame 10 each has a slot/indent at the center, shown particularly in fig. 5 with cross-sectional arrows 6 extending from each slot),
wherein at least one second protrusion 50/32 is formed on an upper surface of a central part of the lower moldable component 12 and a lower surface of a central part of the upper moldable component 7 (fig. 7 and [0034], teeth 50 of adjustment blocks 48 are formed on and supported by the upper surface of the central part of the lower moldable component 12 (i.e., any part of the moldable component 12 within its outer perimeter being interpreted as the central part), since the lower frame 10 is on and supported by lower moldable component 12; similarly, fig. 8, teeth 32 of channels 30 are formed on an supported by the lower surface of the central part of the upper moldable component 7 (i.e., any part of the moldable component 7 within its outer perimeter being interpreted as the central part), since the upper frame 9 is held on the upper moldable component 7; please note the claims do not require the protrusions to be formed directly on the respective upper and lower surfaces), the at least one second protrusion 50 of the lower moldable component 12 contacting the at least one second protrusion 3 of the moldable component 7 (figs. 7 and 8 and [0034], the teeth 50 mesh against teeth 32).
Fallon is silent on wherein, during a shaping process, the upper moldable component is connected to the upper frame by first protrusions formed by overflowing material of the upper moldable component when heated and then cooled, wherein, during the shaping process, the lower moldable component is connected to the lower frame by first protrusions formed by overflowing material of the lower moldable component when heated and then cooled.
However, Altieri teaches a mouthguard (fig. 1 and col. 1, lines 15-18), wherein, during a shaping process, an analogous moldable component 11 is connected to a frame 13 by protrusions formed by overflowing material of the moldable component when heated and then cooled (figs. and col. 4, lines 19-26, where rubber material of primary body 11 flows through perforations 40 in reinforcing member 13 to secure the two elements together; however, please note that the protrusions being formed by the overflowing material when heated and cooled is a product by process limitation, since Altieri teaches the protrusions being made of the same material as and being continuous from the moldable component (the final product), regardless of how the forming was completed; please see MPEP 2113; in other words, while the claim limitations do distinguish over Fallon, since Fallon does not disclose the protrusions 16/18/38/40 necessarily being made of the same material and being continuous from the moldable components (which is structurally what these limitations would result in), Altieri does not have to teach the overflowing material being heated and cooled to form the protrusions).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper moldable component/upper frame and lower moldable component/lower frame of Fallon such that during a shaping process, the upper moldable component is connected to the upper frame by protrusions formed by overflowing material of the upper moldable component when heated and then cooled, wherein, during the shaping process, the lower moldable component is connected to the lower frame by protrusions formed by overflowing material of the lower moldable component when heated and then cooled, as taught by Altieri, to ensure a strong and secure connection between each moldable component and their respective frames.
Fallon in view of Altieri is silent on wherein ends of the upper moldable component extend beyond ends of the upper frame in a second direction perpendicular to the first direction, and wherein the ends of the upper moldable component and the ends of the upper frame form a stepped shape.
However, Thornton teaches an oral appliance (fig. 4 and [0077], dental device) wherein ends of an analogous upper moldable component 135 extend beyond ends of an analogous upper frame 100 in a second direction perpendicular to the first direction (fig. 4 and [0077], moldable tray 135 and arched frame 100; as can particularly be seen in the figure, the left rear tip of frame 100 terminates short of the moldable tray 135, such that the tray 135 extends beyond the end in the anterior-posterior direction, which is perpendicular to the first up-down direction; though fig. 4 does not show the right rear tip, fig. 3C shows that at both rear ends, the tray 135 extends past the ends of the frame 100), and wherein the ends of the upper moldable component 135 and the ends of the upper frame 100 form a stepped shape (fig. 4 shows the ends of the tray 135 and frame 100 forming a stepped shape, as the frame 100 ends abruptly short of the end of the tray 135).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the oral appliance of Fallon in view of Altieri such that ends of the upper moldable component extend beyond ends of the upper frame in a second direction perpendicular to the first direction, and wherein the ends of the upper moldable component and the ends of the upper frame form a stepped shape, as taught by Thornton, so that the more rigid frame material does not contact the rear tissues of the mouth, preventing discomfort.
Regarding claim 18, Fallon in view of Altieri further in view of Thornton discloses the claimed invention as discussed above.
Fallon further discloses the at least one slot in the upper frame 9 and the lower frame 10 being configured to accommodate overflowing material of the upper moldable component 7 and the lower moldable component 12, respectively, during a thermoforming process (the slots/indents of each of the frames 9/10 are capable of allowing moldable material of their respective trays 7/12 to overflow through the slot/indent).
Regarding claim 19, Fallon in view of Altieri further in view of Thornton discloses the claimed invention as discussed above.
Fallon further discloses the upper moldable component 7 and the lower moldable component 12 being in a shape of at least one of ovoid arch (figs. 7 and 8, the upper and lower impression trays 7 and 12 form oval-shaped U’s), tapered arch, or square arch, to conform to a curvature of the user’s upper dental arch and the user’s lower dental arch, respectively.
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallon et al. US 2012/0145166 A1 in view of Ruth et al. US 2018/0206957 A1 further in view of Altieri US 2,827,899 and Thornton et al. US 2014/0053852 A1.
Regarding claim 6, Fallon discloses an oral appliance 1 (fig. 8 and abstract, intraoral mandibular advancement device), comprising:
an upper tray assembly 7/9 configured to be positioned within a user’s oral cavity adjacent to a user’s upper dental arch (fig. 8 and [0023], upper chassis 9 and upper tray 7 form the upper tray assembly 7/9);
a lower tray assembly 10/12 configured to be positioned within the user’s oral cavity adjacent to a user’s lower dental arch (fig. 8 and [0023], lower chassis 10 and lower tray 12 form the upper tray assembly 10/12);
wherein the upper tray assembly 7/9 includes an upper moldable component 7 and an upper frame 9 stacked in a first direction ([0022], upper bite impression tray 7 is made from soft impressionable material, and upper chassis 9 is made from relatively hard and rigid material; fig. 7, the elements are stacked in the vertical direction as shown);
wherein the lower tray assembly 10/12 includes a lower moldable component 12 and a lower frame 10 stacked in the first direction ([0023], lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material; fig. 7, the elements are stacked in the vertical direction as shown);
the upper moldable component 7 and the lower moldable component 12 including a moldable material that can deform when heated, and the upper frame 9 and the lower frame 10 do not deform when heated to a temperature required for deforming the upper moldable component 7 and the lower moldable component 12 ([0022]-[0023], the moldable material is EVA; as evidenced by Brett et al. US 6,584,978 B1 in col. 1, lines 49-53, EVA has a softening point at approximately the temp of boiling water; [0045], the appliance 1 is warmed in boiling water so that the patient can bite into the moldable trays 7 and 9, which is compressed against the relatively hard upper and lower chassis 9 and 10, indicating that the chassis 9/10 have a deformation temperature greater than 100 degrees Celsius since they did not soften at the same temperature as the EVA);
wherein the upper moldable component 7 is configured to be detachably connectable to an upper surface of the upper frame 9 (fig. 8 and [0025]-[0026], upper tray 7 is coupled to the upper surface of frame 9 via protrusions 16/18 that fit into openings 20/22; thus, tray 7 would be capable of detaching from frame 9 by removing the protrusions from the openings);
wherein the lower moldable component 12 is configured to be detachably connectable to a lower surface of the lower frame 10 (fig. 7 and [0030]-[0031], lower tray 12 is coupled to the lower surface of frame 10 via protrusions 38/40 that fit into openings 42/44; thus, tray 12 would be capable of detaching from frame 10 by removing the protrusions from the openings),
wherein at least one second protrusion 50/32 is formed on an upper surface of a central part of the lower moldable component 12 and a lower surface of a central part of the upper moldable component 7 (fig. 7 and [0034], teeth 50 of adjustment blocks 48 are formed on and supported by the upper surface of the central part of the lower moldable component 12 (i.e., any part of the moldable component 12 within its outer perimeter being interpreted as the central part), since the lower frame 10 is on and supported by lower moldable component 12; similarly, fig. 8, teeth 32 of channels 30 are formed on an supported by the lower surface of the central part of the upper moldable component 7 (i.e., any part of the moldable component 7 within its outer perimeter being interpreted as the central part), since the upper frame 9 is held on the upper moldable component 7; please note the claims do not require the protrusions to be formed directly on the respective upper and lower surfaces), the at least one second protrusion 50 of the lower moldable component 12 contacting the at least one second protrusion 3 of the moldable component 7 (figs. 7 and 8 and [0034], the teeth 50 mesh against teeth 32).
Fallon is silent on a projected area of the upper moldable component on a horizontal plane being greater than a projected area of the upper frame on the same plane; and wherein a projected area of the lower moldable component on a horizontal plane is greater than a projected area of the lower frame on the same plane.
However, Ruth teaches an oral tray comprising a moldable component ([0001], impression tray for curing an impression material), wherein a projected area of a moldable component on a horizontal plane is greater than a projected area of the tray/frame on the same plane (fig. 15 and [0094], impression material in impression tray 8 overflows to create overhanging portions 1118/1122/1124 as can be seen in the figure, which would cause the projected area of the impression material on the horizontal plane to be greater than the tray itself).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper moldable component and the lower moldable component of Fallon such that a projected area of the upper moldable component on a horizontal plane is greater than a projected area of the upper frame on the same plane; and wherein a projected area of the lower moldable component on a horizontal plane is greater than a projected area of the lower frame on the same plane, as taught by Ruth, to cushion the surrounding oral tissue from any harder edges of the frames; since Fallon’s upper and lower moldable trays 7/12 are formed by the user biting into impression material, the modification provided by Ruth would allow the impression material to overflow over the edges of the respective frames 9/10.
Fallon in view of Ruth is silent on wherein, during a shaping process, the upper moldable component is connected to the upper frame by first protrusions formed by overflowing material of the upper moldable component when heated and then cooled, and wherein, during the shaping process, the lower moldable component is connected to the lower frame by first protrusions formed by overflowing material of the lower moldable component when heated and then cooled.
However, Altieri teaches a mouthguard (fig. 1 and col. 1, lines 15-18), wherein, during a shaping process, an analogous moldable component 11 is connected to a frame 13 by first protrusions formed by overflowing material of the moldable component when heated and then cooled (figs. and col. 4, lines 19-26, where rubber material of primary body 11 flows through perforations 40 in reinforcing member 13 to secure the two elements together; however, please note that the protrusions being formed by the overflowing material when heated and cooled is a product by process limitation, since Altieri teaches the protrusions being made of the same material as and being continuous from the moldable component (the final product), regardless of how the forming was completed; please see MPEP 2113; in other words, while the claim limitations do distinguish over Fallon, since Fallon does not disclose the protrusions 16/18/38/40 necessarily being made of the same material and being continuous from the moldable components (which is structurally what these limitations would result in), Altieri does not have to teach the overflowing material being heated and cooled to form the protrusions).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper moldable component/upper frame and lower moldable component/lower frame of Fallon in view of Ruth such that during a shaping process, the upper moldable component is connected to the upper frame by first protrusions formed by overflowing material of the upper moldable component when heated and then cooled, and wherein, during the shaping process, the lower moldable component is connected to the lower frame by first protrusions formed by overflowing material of the lower moldable component when heated and then cooled, as taught by Altieri, to ensure a strong and secure connection between each moldable component and their respective frames.
Fallon in view of Altieri is silent on wherein ends of the lower moldable component extend beyond ends of the lower frame in a second direction perpendicular to the first direction, and wherein the ends of the lower moldable component and the ends of the lower frame form a stepped shape.
However, Thornton teaches an oral appliance (fig. 4 and [0077], dental device) wherein ends of an analogous lower moldable component 235 extend beyond ends of an analogous lower frame 200 in a second direction perpendicular to the first direction (fig. 4 and [0077], moldable tray 235 and arched frame 200; as can particularly be seen in the figure, the left rear tip of frame 200 terminates short of the moldable tray 235, such that the tray 235 extends beyond the end in the anterior-posterior direction, which is perpendicular to the first up-down direction; though fig. 4 does not show the right rear tip, it is understood that it follows the configuration of the left rear tip), and wherein the ends of the lower moldable component 235 and the ends of the lower frame 200 form a stepped shape (fig. 4 shows the ends of the tray 235 and frame 200 forming a stepped shape, as the frame 200 ends abruptly short of the end of the tray 235).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the oral appliance of Fallon in view of Altieri such that ends of the lower moldable component extend beyond ends of the lower frame in a second direction perpendicular to the first direction, and wherein the ends of the lower moldable component and the ends of the lower frame form a stepped shape, as taught by Thornton, so that the more rigid frame material does not contact the rear tissues of the mouth, preventing discomfort.
Regarding claim 7, Fallon in view of Ruth further in view of Altieri and Thornton discloses the claimed invention as discussed above.
Fallon further discloses the temperature required for deforming the moldable material of the upper moldable component 7 and the lower moldable component 12 being less than 100 degrees Celsius ([0022]-[0023], the moldable material is EVA; as evidenced by Brett et al. US 6,584,978 B1 in col. 1, lines 49-53, EVA has a softening point at approximately the temp of boiling water, which is 100 degrees C; thus, EVA’s softening point can be considered 100 degrees C, and including slightly below and above).
Regarding claim 8, Fallon in view of Ruth further in view of Altieri and Thornton discloses the claimed invention as discussed above.
Fallon further discloses the upper frame 9 and the lower frame 10 including a material with high temperature stability, and a temperature required for deforming the upper frame 9 and the lower frame 10 is greater than 100 degrees Celsius ([0045], the appliance 1 is warmed in boiling water so that the patient can bite into the moldable trays 7 and 9, which is compressed against the relatively hard upper and lower chassis 9 and 10, indicating that the chassis 9/10 have a deformation temperature greater than 100 degrees Celsius since they did not soften at the same temperature as the EVA (which has a softening temperature of approximately 100 C, as evidenced by Brett et al. US 6,584,978 B1 in col. 1, lines 49-53); thus, the frames 9/10 can be considered more temperature-stable).
Regarding claim 9, Fallon in view of Ruth further in view of Altieri and Thornton discloses the claimed invention as discussed above.
Ruth further teaches a ratio of the projected area of the upper moldable component 7 and the lower moldable component 12 to the projected area of the upper frame 9 and the lower frame 10 on a horizontal plane being greater than 1 (as discussed above in claim 6, Ruth teaches in [0094] impression material in impression tray 8 overflowing to create overhanging portions 1118/1122/1124 as can be seen in fig. 15, which would cause the projected area of the impression material on the horizontal plane to be greater than the tray itself (and thus the ratio of their projected areas would be greater than 1), to cushion the surrounding oral tissue from any harder edges of the frames; since Fallon’s upper and lower moldable trays 7/12 are formed by the user biting into impression material, the modification provided by Ruth would allow the impression material to overflow over the edges of the respective frames 9/10.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallon et al. US 2012/0145166 A1 in view of Altieri US 2,827,899 further in view of Thornton et al. US 2014/0053852 A1 and Going et al. US 4,063,552.
Regarding claim 20, Fallon in view of Altieri further in view of Thornton discloses the claimed invention as discussed above.
Fallon further discloses wherein the upper frame 9 and the lower frame 10 have at least one inner wall and at least one outer wall (figs. 4 and 6, the inner walls of frames 9 and 10 being the inner surfaces that directly face trays 7 and 12, and the outer walls forming the outwardly facing surfaces of the device directed away from inner trays 7 and 12).
Fallon in view of Altieri further in view of Thornton is silent on a distance between the at least one inner wall and the at least one outer wall being between 0.3 mm to 8 mm.
However, Going teaches an analogous frame 1 (fig. 1 and col. 5, lines 24-27, outer portion 1), a distance between the at least one inner wall and the at least one outer wall being between 0.3 mm to 8 mm (col. 5, lines 29-30, the outer portion may be 0.5 mm thick, meaning the distance between its inner wall/surface and outer wall/surface is 0.5 mm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper and lower frames of Fallon in view of Altieri further in view of Thornton such that a distance between the at least one inner wall and the at least one outer wall is between 0.3 mm to 8 mm, as taught by Going, so as not to be too bulky and/or heavy in the mouth.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786
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