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, 7, 13, and 18 in the response filed 6/30/26 are acknowledged.
Claims 1-20 and 22 are still pending in the application and are examined below.
Response to Arguments
Applicant's arguments filed 6/30/26 have been fully considered but they are not persuasive. Applicant’s arguments regarding the prior art of record failing to disclose or teach the newly added limitations regarding the corresponding protrusions are moot in view of new reference Adell provided to address these limitations.
Claim Objections
Claim 13 is objected to because of the following informalities: “are located” in the last line of the claim should be amended to recite --are configured to be located--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 13, the claim recites the limitation “the corresponding protrusions are located only at incisor positions” in the last line of the claim. This subject matter was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. P. 12, lines 7-9 describe the protrusions and slots being symmetrically distributed near the middle part close to the patient’s incisors, but the specification does not otherwise explicitly state that the protrusions are located only at incisor positions.
Regarding claims 14-17, the claims are rejected under 35 U.S.C 112(a) by virtue of their dependence on claim 13.
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 7-12 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.
Regarding claim 7, the claim recites the limitations “the total area” and “the remaining area” in lines 26-27. There is insufficient antecedent basis for these limitations in the claim. The total area of the corresponding protrusions is interpreted to mean a total surface area, and the remaining area of the bottom wall is interpreted to mean an area of the bottom wall except for the protrusions.
Regarding claims 8-12, the claims are rejected under 35 U.S.C. 112(b) by virtue of their dependence on claim 7.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “adjustment module” in claims 15 and 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallon et al. US 2012/0145166 A1 in view of Adell US 5,082,007 further in view of Going et al. US 4,063,552 and Ruth et al. US 2018/0206957 A1.
Regarding claim 1, Fallon discloses a mandibular advancement device 1 (fig. 8 and abstract, intraoral mandibular advancement device) with a support baffle (please see annotated fig. A below, where the support baffle is the lingual wall of lower chassis 10), the mandibular advancement device 1 comprising:
an upper tray assembly 7/9, configured to have an arcuate outer shape to conform to an upper dental arch curve of a patient (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);
a lower tray assembly 10/12, configured to have an arcuate outer shape to conform to a lower dental arch curve of the patient (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);
wherein the upper tray assembly 7/9 includes an upper moldable component 7 and an upper frame 9 ([0022], upper bite impression tray 7 is made from soft impressionable material, and upper chassis 9 is made from relatively hard and rigid material);
wherein the lower tray assembly 10/12 includes a lower moldable component 12 and a lower frame 10 ([0023], lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material);
wherein the lower frame 10 includes the support baffle, configured to be positioned on the lower frame 10 near a tongue side during use (annotated fig. A, the support baffle being the lingual wall of lower chassis 10; [0029], lower impression tray 12 lays below and against the lower chassis 10, and thus the lingual wall of lower chassis 10 forms a support baffle against which the tray 12 rests);
wherein the support baffle has a top edge and a bottom edge (annotated fig. A, where the bottom edge of the support baffle is along the bottom edge of the frame where the support baffle meets the occlusal surface of the frame, the bottom direction being in the direction of the occlusal surface of the lower teeth), and a line connecting intersections of the top edge and the bottom edge with a same sagittal plane of the lower frame 10 forms an angle with a horizontal plane between 20 to 150 degrees (please see annotated fig. B below, which shows the top edge and bottom edge of the lingual wall (i.e. support baffle) of the lower chassis 10; this figure is a cross section taken along the sagittal plane of the device, as can be seen in fig. 5; therefore, any vertical line that extends through the top and bottom edges (such as the dashed line in the annotated figure) is a line that connects intersections of the top edge and bottom edge with the sagittal plane of the lower frame; the dashed line is vertical and thus forms a 90 degree angle with the horizontal plane), and
wherein the support baffle is configured to counteract a deforming force on the lower moldable component 12 and support the lower moldable component 12 ([0029], lower impression tray 12 lays below and against the lower chassis 10 (which forms the support baffle), and thus the lower chassis 10 supports the impression tray 12; further, as described in [0023], since lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material, lower chassis 10 is capable of counteracting a deforming force on the impression tray 12 by providing a supporting/bracing wall surrounding the outside of the tray 12).
Fallon is silent on wherein the upper frame and the lower frame comprise corresponding protrusions at a bottom wall of the upper frame and the lower frame respectively, and are configured to form a space between the upper frame and the lower frame for airflow circulation; and wherein each of the corresponding protrusions has a sagittal length greater than a coronal width thereof.
However, Adell teaches a mouthguard 30 (fig. 1 and col. 3, lines 22-23) comprising an upper frame 32 and lower frame 34 comprising corresponding protrusions at a bottom wall of the upper frame 32 and the lower frame 34 respectively, and are configured to form a space between the upper frame 32 and the lower frame 34 for airflow circulation (please see annotated fig. E below, where the upper and lower frames have corresponding protrusions on their occlusal/bottom walls, which form spaces for airflow); and wherein each of the corresponding protrusions has a sagittal length greater than a coronal width thereof (annotated fig. E the corresponding protrusions are longer in the sagittal direction than the coronal direction, which can also be particularly seen in fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the upper frame and the lower frame with corresponding protrusions at a bottom wall of the upper frame and the lower frame respectively, and are configured to form a space between the upper frame and the lower frame for airflow circulation; and wherein each of the corresponding protrusions has a sagittal length greater than a coronal width thereof, as taught by Adell, to provide prominent passageways for adequate and comfortable breathing.
Fallon in view of Adell is silent on a thickness of the support baffle being between 0.3 mm to 10 mm.
However, Going teaches a mouthguard (fig. 1 and col. 1, lines 3-6) comprising an analogous rigid outer tray/frame 1 (fig. 1 and col. 5, lines 24-25; col. 6, lines 26-28) having a thickness between 0.3 mm to 10 mm (col. 5, lines 27-30, 0.5 mm thick).
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 thickness of the outer/lower frame comprising the support baffle of Fallon in view of Adell to have a thickness between 0.3 mm to 10 mm, as taught by Going, as a thin frame would provide the rigid support while not being too bulky or heavy in the mouth; please also note that the specification does not provide evidence as to the criticality of the claimed range.
Fallon in view of Adell further in view of Going is silent on the upper moldable component having a projected area greater than a projected area of the upper frame; the lower moldable component having a projected area greater than a projected area of the lower frame.
However, Ruth teaches an oral tray comprising a moldable component ([0001], impression tray for curing an impression material), wherein the moldable component has a projected area greater than a projected area of the tray/frame (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 in view of Adell further in view of Going such that the upper moldable component has a projected area greater than a projected area of the upper frame; the lower moldable component has a projected area greater than a projected area of the lower frame, 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.
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Regarding claim 2, Fallon in view of Adell further in view of Going and Ruth discloses the claimed invention as discussed above.
Fallon further discloses arcuate shapes of the upper moldable component 7 and the lower moldable component 12 including at least one of an ovoid arch shape (figs. 7 and 8, the upper and lower impression trays 7 and 12 form oval-shaped U’s), a conical arch shape, and a square arch shape.
Regarding claim 3, Fallon in view of Adell further in view of Going and Ruth discloses the claimed invention as discussed above.
Fallon further discloses the upper moldable component 7 and the lower moldable component 12 being configured to at least partially conform to the upper dental arch and the lower dental arch of the patient during use, respectively ([0029], the impression trays 7/12 are shaped when the patient bites into them).
Regarding claim 4, Fallon in view of Adell further in view of Going and Ruth discloses the claimed invention as discussed above.
Fallon further discloses a length of the bottom edge of the support baffle being greater than 10% of an overall curve length at a bottom edge of the lower frame 10 (annotated fig. A, the length of the support baffle extends about 1/3 the total inner bottom edge of the lower chassis 10, at least greater than 10%).
Regarding claim 5, Fallon in view of Adell further in view of Going and Ruth 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 6, Fallon in view of Adell further in view of Going and Ruth discloses the claimed invention as discussed above.
Fallon further discloses a hardness of a material of the upper frame 9 and the lower frame 10 being at least partially greater than a hardness of a material of the upper moldable component 7 and the lower moldable component 12 ([0022]-[0023], bite impression trays 7/12 are made from soft impressionable material, and chassis 9/10 are made from relatively hard and rigid material).
Claim(s) 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallon et al. US 2012/0145166 A1 in view of Gottsch US 2015/0040917 A1 further in view of Adell US 5,082,007, Going et al. US 4,063,552, and Ruth et al. US 2018/0206957 A1.
Regarding claim 7, Fallon discloses a mandibular advancement device 1 (fig. 8 and abstract, intraoral mandibular advancement device) with a support baffle (please see annotated fig. A, where the support baffle is the lingual wall of lower chassis 10), the mandibular advancement device 1 comprising:
an upper tray assembly 7/9, configured to be positioned adjacent to an upper dental arch of a patient when located in the patient’s oral cavity (fig. 8 and [0023], upper chassis 9 and upper tray 7 form the upper tray assembly 7/9, which receives the teeth of the upper jaw, as described in [0022]);
a lower tray assembly 10/12, configured to positioned adjacent to a lower dental arch of the patient when located in the patient’s oral cavity (fig. 8 and [0023], lower chassis 10 and lower tray 12 form the upper tray assembly 10/12, which receives the teeth of the lower jaw);
wherein the upper tray assembly 7/9 includes an upper moldable component 7 and an upper frame 9 ([0022], upper bite impression tray 7 is made from soft impressionable material, and upper chassis 9 is made from relatively hard and rigid material);
wherein the lower tray assembly 10/12 includes a lower moldable component 12 and a lower frame 10 ([0023], lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material);
wherein the lower frame 10 includes the support baffle, configured to be positioned on the lower frame 10 near a tongue side during use (annotated fig. A, the support baffle being the lingual wall of lower chassis 10; [0029], lower impression tray 12 lays below and against the lower chassis 10, and thus the lingual wall of lower chassis 10 forms a support baffle against which the tray 12 rests), and wherein a top edge of the support baffle slants from the lower frame 10 (annotated fig. A, the top edge of the support baffle begins on each side from the occlusal wall of the lower frame and then slants downwards to its greatest height in the center),
wherein the support baffle is configured to counteract a deforming force on the lower moldable component 12 and support the lower moldable component 12 ([0029], lower impression tray 12 lays below and against the lower chassis 10 (which forms the support baffle), and thus the lower chassis 10 supports the impression tray 12; further, as described in [0023], since lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material, lower chassis 10 is capable of counteracting a deforming force on the impression tray 12 by providing a supporting/bracing wall surrounding the outside of the tray 12).
Fallon is silent on wherein, in an orthogonal view from below, the support baffle has a shaded area, and a ratio of the shaded area to an area of the lower frame in the orthogonal view from below is less than or equal to 2:5.
However, Gottsch teaches an analogous lower oral tray 300 (fig. 3 and [0028], stabilizing mouthpiece 300 for use on lower teeth), wherein, in an orthogonal view from below, an analogous support baffle 342 has a shaded area 318 (fig. 3 and [0033], bottom ridge 342 being analogous to Fallon’s support baffle, as it is a ridge/orthogonally-extending lingual wall that extends along the inner edge of the lower tray 300 and protrudes downwards; the orthogonal view of the anterior surface 318 is shaded), and a ratio of the shaded area 318 to an area of the lower frame 300 in the orthogonal view from below is less than or equal to 2:5 (fig. 3, the shaded area is less than 40% of the overall area of the tray 300 in the orthogonal view shown).
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 support baffle of Fallon such that in an orthogonal view from below, the support baffle has a shaded area, and a ratio of the shaded area to an area of the lower frame in the orthogonal view from below is less than or equal to 2:5, as taught by Gottsch, since a small cross sectional area of the support baffle would keep bulkiness of the oral appliance to a minimum.
Fallon in view of Gottsch is silent on the upper frame and the lower frame comprising corresponding protrusions at a bottom wall of the upper frame and the lower frame respectively, and are configured to form a space between the upper frame and the lower frame for airflow circulation; and wherein the total area of the corresponding protrusions is smaller than the remaining area of the bottom wall.
However, Adell teaches a mouthguard 30 (fig. 1 and col. 3, lines 22-23) comprising an upper frame 32 and lower frame 34 comprising corresponding protrusions at a bottom wall of the upper frame 32 and the lower frame 34 respectively, and are configured to form a space between the upper frame 32 and the lower frame 34 for airflow circulation (please see annotated fig. E, where the upper and lower frames have corresponding protrusions on their occlusal/bottom walls, which form spaces for airflow); and wherein the total area of the corresponding protrusions is smaller than the remaining area of the bottom wall (annotated fig. E, the surface area of each protrusion being less than the areas of the respective bottom/occlusal walls on which they are situated; please see the 112(b) rejection above for the interpretation of “the remaining area”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the upper frame and the lower frame of Fallon in view of Gottsch with protrusions at a bottom wall of the upper frame and the lower frame respectively, and are configured to form a space between the upper frame and the lower frame for airflow circulation; and wherein the total area of the corresponding protrusions is smaller than the remaining area of the bottom wall, as taught by Adell, to provide prominent passageways for adequate and comfortable breathing.
Fallon in view of Gottsch further in view of Adell is silent on a thickness of the support baffle being between 0.3 mm to 10 mm.
However, Going teaches a mouthguard (fig. 1 and col. 1, lines 3-6) comprising an analogous rigid outer tray/frame 1 (fig. 1 and col. 5, lines 24-25; col. 6, lines 26-28) having a thickness between 0.3 mm to 10 mm (col. 5, lines 27-30, 0.5 mm thick).
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 thickness of the outer/lower frame comprising the support baffle of Fallon in view of Gottsch further in view of Adell to have a thickness between 0.3 mm to 10 mm, as taught by Going, as a thin frame would provide the rigid support while not being too bulky or heavy in the mouth; please also note that the specification does not provide evidence as to the criticality of the claimed range.
Fallon in view of Gottsch further in view of Adell and Going is silent on the upper moldable component having a projected area greater than a projected area of the upper frame; the lower moldable component having a projected area greater than a projected area of the lower frame.
However, Ruth teaches an oral tray comprising a moldable component ([0001], impression tray for curing an impression material), wherein the moldable component has a projected area greater than a projected area of the tray/frame (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 in view of Gottsch further in view of Adell and Going such that the upper moldable component has a projected area greater than a projected area of the upper frame; the lower moldable component has a projected area greater than a projected area of the lower frame, 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.
Regarding claim 8, Fallon in view of Gottsch further in view of Adell, Going, and Ruth discloses the claimed invention as discussed above.
Fallon further discloses the support baffle being divided into multiple spaced-apart sections (please see annotated fig. C below, which shows the cross section of the lingual wall of the chassis 10 (the support baffle) being divided into two sections spaced apart by a gap).
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Regarding claim 9, Fallon in view of Gottsch further in view of Adell, Going, and Ruth discloses the claimed invention as discussed above.
Fallon further discloses the lower moldable component 12 having a shape that engages and matches the support baffle (fig. 6, the lower impression tray 12 lines the inside of the lower chassis 10 such that it engages and matches the inner boundary of the lower chassis 10, including its lingual wall (support baffle)).
Regarding claim 10, Fallon in view of Gottsch further in view of Adell, Going, and Ruth discloses the claimed invention as discussed above.
Fallon further discloses the upper moldable component 7 and the lower moldable component 12 being configured to soften when heated, to allow them to be adjusted and molded to respectively match the upper dental arch and the lower dental arch of the patient upon biting down ([0045], the appliance 1 is warmed in boiling water before the patient bites down into the soft impression trays 7/12 to form impressions).
Regarding claim 11, Fallon in view of Gottsch further in view of Adell, Going, and Ruth discloses the claimed invention as discussed above.
Fallon further discloses the upper moldable component 7 and the lower moldable component 12 including a moldable material having a deformation temperature of 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 12, Fallon in view of Gottsch further in view of Adell, Going, and Ruth discloses the claimed invention as discussed above.
Fallon further discloses the upper frame 9 and the lower frame 10 including a high-temperature stable material having a deformation temperature 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 discussed above in claim 11)).
Claim(s) 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallon et al. US 2012/0145166 A1 in view of Gottsch US 2015/0040917 A1 further in view of Going et al. US 4,063,552, Ruth et al. US 2018/0206957 A1, and Adell US 5,082,007.
Regarding claim 13, Fallon discloses a mandibular advancement device 1 (fig. 8 and abstract, intraoral mandibular advancement device) with a support baffle (please see annotated fig. A, where the support baffle is the lingual wall of lower chassis 10), the mandibular advancement device 1 comprising:
an upper tray assembly 7/9, configured to be positioned adjacent to an upper dental arch of a patient when located in the patient’s oral cavity (fig. 8 and [0023], upper chassis 9 and upper tray 7 form the upper tray assembly 7/9, which receives the teeth of the upper jaw, as described in [0022]);
a lower tray assembly 10/12, configured to positioned adjacent to a lower dental arch of the patient when located in the patient’s oral cavity (fig. 8 and [0023], lower chassis 10 and lower tray 12 form the upper tray assembly 10/12, which receives the teeth of the lower jaw);
wherein the upper tray assembly 7/9 includes an upper moldable component 7 and an upper frame 9 ([0022], upper bite impression tray 7 is made from soft impressionable material, and upper chassis 9 is made from relatively hard and rigid material);
wherein the lower tray assembly 10/12 includes a lower moldable component 12 and a lower frame 10 ([0023], lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material);
wherein the lower frame 10 includes the support baffle, configured to be positioned on the lower frame 10 near a tongue side during use (annotated fig. A, the support baffle being the lingual wall of lower chassis 10; [0029], lower impression tray 12 lays below and against the lower chassis 10, and thus the lingual wall of lower chassis 10 forms a support baffle against which the tray 12 rests);
wherein the support baffle has a shape that is higher in a middle and lower on both sides (annotated fig. A shows the support baffle having a higher/greater height in the middle and lower/smaller height on the sides, since the baffle curves downward and increases in height towards the center; please note that Fallon’s support baffle is “higher” in the downward direction in the middle in the same way that Applicant’s support baffle is “higher” in the downward direction, as shown in fig. 3 of Applicant’s figures), and wherein a top edge of the support baffle slants from the lower frame 10 (annotated fig. A, the top edge of the support baffle begins on each side from the occlusal wall of the lower frame and then slants downwards to its greatest height in the center), and
wherein the support baffle is configured to counteract a deforming force on the lower moldable component 12 and support the lower moldable component 12 ([0029], lower impression tray 12 lays below and against the lower chassis 10 (which forms the support baffle), and thus the lower chassis 10 supports the impression tray 12; further, as described in [0023], since lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material, lower chassis 10 is capable of counteracting a deforming force on the impression tray 12 by providing a supporting/bracing wall surrounding the outside of the tray 12).
Fallon is silent on wherein, in an orthogonal view from below, the support baffle has a shaded area, and a ratio of the shaded area to an area of the lower frame in the orthogonal view from below is less than or equal to 2:5.
However, Gottsch teaches an analogous lower oral tray 300 (fig. 3 and [0028], stabilizing mouthpiece 300 for use on lower teeth), wherein, in an orthogonal view from below, an analogous support baffle 342 has a shaded area 318 (fig. 3 and [0033], bottom ridge 342 being analogous to Fallon’s support baffle, as it is a ridge/orthogonally-extending lingual wall that extends along the inner edge of the lower tray 300 and protrudes downwards; the orthogonal view of the anterior surface 318 is shaded), and a ratio of the shaded area 318 to an area of the lower frame 300 in the orthogonal view from below is less than or equal to 2:5 (fig. 3, the shaded area is less than 40% of the overall area of the tray 300 in the orthogonal view shown).
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 support baffle of Fallon such that in an orthogonal view from below, the support baffle has a shaded area, and a ratio of the shaded area to an area of the lower frame in the orthogonal view from below is less than or equal to 2:5, as taught by Gottsch, since a small cross sectional area of the support baffle would keep bulkiness of the oral appliance to a minimum.
Fallon in view of Gottsch is silent on a thickness of the support baffle being between 0.3 mm to 10 mm.
However, Going teaches a mouthguard (fig. 1 and col. 1, lines 3-6) comprising an analogous rigid outer tray/frame 1 (fig. 1 and col. 5, lines 24-25; col. 6, lines 26-28) having a thickness between 0.3 mm to 10 mm (col. 5, lines 27-30, 0.5 mm thick).
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 thickness of the outer/lower frame comprising the support baffle of Fallon in view of Gottsch to have a thickness between 0.3 mm to 10 mm, as taught by Going, as a thin frame would provide the rigid support while not being too bulky or heavy in the mouth; please also note that the specification does not provide evidence as to the criticality of the claimed range.
Fallon in view of Gottsch further in view of Going is silent on the upper moldable component having a projected area greater than a projected area of the upper frame; the lower moldable component having a projected area greater than a projected area of the lower frame.
However, Ruth teaches an oral tray comprising a moldable component ([0001], impression tray for curing an impression material), wherein the moldable component has a projected area greater than a projected area of the tray/frame (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 in view of Gottsch further in view of Going such that the upper moldable component has a projected area greater than a projected area of the upper frame; the lower moldable component has a projected area greater than a projected area of the lower frame, 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 Gottsch further in view of Going and Ruth is silent on the upper frame and the lower frame comprising corresponding protrusions at a bottom wall of the upper frame and the lower frame respectively, and are configured to form a space between the upper frame and the lower frame for airflow circulation; and wherein the corresponding protrusions are located only at incisor positions.
However, Adell teaches a mouthguard 30 (fig. 1 and col. 3, lines 22-23) comprising an upper frame 32 and lower frame 34 comprising corresponding protrusions at a bottom wall of the upper frame 32 and the lower frame 34 respectively, and are configured to form a space between the upper frame 32 and the lower frame 34 for airflow circulation (please see annotated fig. E below, where the upper and lower frames have corresponding protrusions on their occlusal/bottom walls, which form spaces for airflow); and wherein the corresponding protrusions are located only at incisor positions (annotated fig. E, the corresponding protrusions are along the anterior portion of the mouthguard, such that they are capable of being in the area of the incisors when worn, depending on the exact formation of the wearer’s teeth).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the upper frame and the lower frame of Fallon in view of Gottsch further in view of Going and Ruth with corresponding protrusions at a bottom wall of the upper frame and the lower frame respectively, and are configured to form a space between the upper frame and the lower frame for airflow circulation; and wherein the corresponding protrusions are located only at incisor positions, as taught by Adell, to provide prominent passageways for adequate and comfortable breathing.
Regarding claim 14, Fallon in view of Gottsch further in view of Going, Ruth, and Adell discloses the claimed invention as discussed above.
Fallon further discloses the upper frame 9 and the lower frame 10 being configured to engage and support the upper moldable component 7 and the lower moldable component 12, respectively (fig. 6 and [0022]-[0023], upper chassis 9 receives, engages, and supports upper tray 7, while lower chassis 10 receives, engages, and supports lower tray 12).
Regarding claim 15, Fallon in view of Gottsch further in view of Going, Ruth, and Adell discloses the claimed invention as discussed above.
Fallon further discloses a position adjustment module 30/48 being provided between the upper frame 9 and the lower frame 10 (figs. 8 and 9 and [0028], locking channels on the bottom of upper chassis 9 receive adjustment blocks 48 on the top of lower chassis 10 to create an adjustable interlocking arrangement).
Regarding claim 16, Fallon in view of Gottsch further in view of Going, Ruth, and Adell discloses the claimed invention as discussed above.
Fallon further discloses the position adjustment module 30/48 having two or more adjustment positions (figs. 8 and 9 and [0028], teeth on the side of channel 30 receive respective interlocking teeth of blocks 48; therefore, each tooth position would be a different adjustment position).
Regarding claim 17, Fallon in view of Gottsch further in view of Going, Ruth, and Adell discloses the claimed invention as discussed above.
Fallon further discloses a maximum height of the support baffle being less than or equal to a maximum height of the lower moldable component 12 (fig. 6 shows the height of the lower tray 12 being greater than the height of chassis 10 at this cross section, which is taken in the center sagittal plane of the device, as shown in fig. 5, where the support baffle is located).
Claim(s) 18-20 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallon et al. US 2012/0145166 A1 in view of Going et al. US 4,063,552 further in view of Ruth et al. US 2018/0206957 A1 and Adell US 5,082,007.
Regarding claim 18, Fallon discloses a mandibular advancement device 1 (fig. 8 and abstract, intraoral mandibular advancement device) with a support baffle (please see annotated fig. A, where the support baffle is the lingual wall of lower chassis 10), the mandibular advancement device 1 comprising:
an upper tray assembly 7/9, configured to be positioned adjacent to an upper dental arch of a patient when located in the patient’s oral cavity (fig. 8 and [0023], upper chassis 9 and upper tray 7 form the upper tray assembly 7/9, which receives the teeth of the upper jaw, as described in [0022]);
a lower tray assembly 10/12, configured to positioned adjacent to a lower dental arch of the patient when located in the patient’s oral cavity (fig. 8 and [0023], lower chassis 10 and lower tray 12 form the upper tray assembly 10/12, which receives the teeth of the lower jaw);
wherein the upper tray assembly 7/9 includes an upper moldable component 7 and an upper frame 9 ([0022], upper bite impression tray 7 is made from soft impressionable material, and upper chassis 9 is made from relatively hard and rigid material);
wherein the lower tray assembly 10/12 includes a lower moldable component 12 and a lower frame 10 ([0023], lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material);
wherein the lower frame 10 includes the support baffle, configured to be positioned on the lower frame 10 near a tongue side during use (annotated fig. A, the support baffle being the lingual wall of lower chassis 10; [0029], lower impression tray 12 lays below and against the lower chassis 10, and thus the lingual wall of lower chassis 10 forms a support baffle against which the tray 12 rests);
wherein the support baffle is configured to counteract a deforming force on the lower moldable component 12 and support the lower moldable component 12 ([0029], lower impression tray 12 lays below and against the lower chassis 10 (which forms the support baffle), and thus the lower chassis 10 supports the impression tray 12; further, as described in [0023], since lower bite impression tray 12 is made from soft impressionable material, and lower chassis 10 is made from relatively hard and rigid material, lower chassis 10 is capable of counteracting a deforming force on the impression tray 12 by providing a supporting/bracing wall surrounding the outside of the tray 12).
wherein the support baffle has one or more of the following characteristics:
A: having a top edge and a bottom edge, and a line connecting intersections of the top edge and the bottom edge with a same sagittal plane of the lower frame 10 forms an angle with a horizontal plane between 20 to 150 degrees (annotated fig. B, which shows the top edge and bottom edge of the lingual wall (i.e. support baffle) of the lower chassis 10; this figure is a cross section taken along the sagittal plane of the device, as can be seen in fig. 5; therefore, any vertical line that extends through the top and bottom edges (such as the dashed line in the annotated figure) is a line that connects intersections of the top edge and bottom edge with the sagittal plane of the lower frame; the dashed line is vertical and thus forms a 90 degree angle with the horizontal plane);
B. a length of the top edge of the support baffle being greater than or equal to 5 mm;
C. a vertical height of the support baffle being less than or equal to 15 mm.
Fallon is silent on a thickness of the support baffle being between 0.3 mm to 10 mm.
However, Going teaches a mouthguard (fig. 1 and col. 1, lines 3-6) comprising an analogous rigid outer tray/frame 1 (fig. 1 and col. 5, lines 24-25; col. 6, lines 26-28) having a thickness between 0.3 mm to 10 mm (col. 5, lines 27-30, 0.5 mm thick).
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 thickness of the outer/lower frame comprising the support baffle of Fallon to have a thickness between 0.3 mm to 10 mm, as taught by Going, as a thin frame would provide the rigid support while not being too bulky or heavy in the mouth; please also note that the specification does not provide evidence as to the criticality of the claimed range.
Fallon in view of Going is silent on the upper moldable component having a projected area greater than a projected area of the upper frame; the lower moldable component having a projected area greater than a projected area of the lower frame.
However, Ruth teaches an oral tray comprising a moldable component ([0001], impression tray for curing an impression material), wherein the moldable component has a projected area greater than a projected area of the tray/frame (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 in view of Going such that the upper moldable component has a projected area greater than a projected area of the upper frame; the lower moldable component has a projected area greater than a projected area of the lower frame, 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 Going further in view of Ruth is silent on the upper frame and the lower frame comprising corresponding protrusions at a bottom wall of the upper frame and the lower frame respectively, and are configured to form a space between the upper frame and the lower frame for airflow circulation; wherein the corresponding protrusions are each in the form of a protruding rectangular prism.
However, Adell teaches a mouthguard 30 (fig. 1 and col. 3, lines 22-23) comprising an upper frame 32 and lower frame 34 comprising corresponding protrusions at a bottom wall of the upper frame 32 and the lower frame 34 respectively, and are configured to form a space between the upper frame 32 and the lower frame 34 for airflow circulation (please see annotated fig. E below, where the upper and lower frames have corresponding protrusions on their occlusal/bottom walls, which form spaces for airflow); wherein the corresponding protrusions are each in the form of a protruding rectangular prism (annotated fig. E, the protrusions each being a protruding rectangular prism).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the upper frame and the lower frame of Fallon in view of Going further in view of Ruth with corresponding protrusions at a bottom wall of the upper frame and the lower frame respectively, and are configured to form a space between the upper frame and the lower frame for airflow circulation; wherein the corresponding protrusions are each in the form of a protruding rectangular prism, as taught by Adell, to provide prominent passageways for adequate and comfortable breathing.
Regarding claim 19, Fallon in view of Going further in view of Ruth and Adell discloses the claimed invention as discussed above.
Fallon further discloses the top edge and the bottom edge of the support baffle having continuous curvature (annotated fig. A, the bottom edge of the support baffle and the top edge are both curved in the horizontal plane of the device due to the U-shaped nature of the chassis 10).
Regarding claim 20, Fallon in view of Going further in view of Ruth and Adell discloses the claimed invention as discussed above.
Fallon further discloses the upper tray assembly 7/9 and the lower tray assembly 10/12 including at least two different materials ([0022]-[0023], bite impression trays 7/12 are made from soft impressionable material, and chassis 9/10 are made from relatively hard and rigid material).
Regarding claim 22, Fallon in view of Going further in view of Ruth and Adell discloses the claimed invention as discussed above.
Fallon further discloses the lower moldable component 12 having a shape that engages and matches the support baffle (fig. 6, the lower impression tray 12 lines the inside of the lower chassis 10 such that it engages and matches the inner boundary of the lower chassis 10, including its lingual wall (support baffle)).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ALIREZA NIA can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786
