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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/21/2026 has been entered.
Response to Amendment
Applicant’s amendments to claims 1 and 23 filed 04/21/2026 is acknowledged by the examiner.
Claims 9, 11, 13, 20, 25-41, and 43-44 remain cancelled.
Claims 1-8, 10, 12, 14-19, 21-24, and 42 are currently pending and are under examination.
Response to Arguments
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive.
Applicant’s argument: Kim discloses a mandibular advancement device having upper and lower splints with fins, but is silent as to any material property or functional behavior relating to recovery after sustained deformation. Shivapuja discloses polymeric materials and discusses Young’s modulus in the context of comfort and flexibility, but likewise does not disclose or suggest any recovery behavior after maintaining deformation for the recited time interval. Thus, none of the cited references discloses or suggests all the features as recited in amended claim 1. The Office Action’s rejection relies on the position that, because the cited references discloses similar structures and polymeric materials having a Young’s modulus within the claimed range, the claimed recovery behavior would be inherent. The Office Action also appears to assume that that materials having a similar Young’s modulus will necessarily exhibit the claimed recovery behavior. However, this reasoning is not supported. Young’s modulus characterizes instantaneous elastic response under load, and does not define or predict time-dependent recovery behavior following prolonged deformation, which is governed by different material phenomena. The Examiner has not provided any technical evidence or reasoning establishing that materials within the claimed modulus range would necessarily and inevitably exhibit the specific recovery behavior defined by the combination of θ, TI, and ω. Accordingly, the assertion of inherency is unsupported. Furthermore, the application of In re Best and In re Spada is not appropriate under the present facts. Those cases apply where the prior art and the claimed invention are shown to be identical or substantially identical in structure or material composition, such that the burden may shift to the applicant to prove a different in properties. Here, the prior art does not disclose a device or material defined by the claimed limitations of material characteristics, and therefore the Examiner has not established that the prior art products are identical or substantially identical to the claimed invention. Additionally, the cited references provide no motivation to select or modify polymeric materials to achieve the claimed recovery behavior after sustained deformation for 15-60 minutes. The references generally address comfort, durability, or general flexibility of intraoral devices, but do not recognize, let alone suggest, controlling recovery to within a defined angular tolerance after prolonged deformation.
Examiner’s response: In light of the amendments to the independent claims, a new prior art reference, Farrell, is disclosed as providing extrinsic evidence that the polymeric material would recover after maintaining deformation. Further, there are no other structures or features in the claims that cause the mandibular advancement device to exhibit this specific recovery property other than the Young’s Modulus claimed. Therefore, the device of KIM in view of SHIVAPUJA still reads on the amended portion of claims 1 and 23, as the recited function (the recovery property) is rendered obvious as the device of KIM in view of SHIVAPUJA comprises the same structures (upper and lower splints with upper and lower fins), and comprises the same Young’s Modulus, and further is evidenced by Farrell to function in this way, as Farrell and SHIVAPUJA both disclose polyurethane as the polymeric material, which is also disclosed as the polymeric material in Applicant’s specification (see Pg. 3 line 9), therefore, because the same polymeric material is disclosed, In re Spada and In re Best is still applied as SHIVAPUJA and Farrell both provide the same material composition (polyurethane). In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine the references does not need to be found in the references themselves, but is knowledge generally available to one of ordinary skill in the art, as the motivation to combine the references to have this recovery property is so that the mandibular advancement device is more comfortable for prolonged periods of time as the mandibular advancement device has enough elasticity to bend and return to its original position providing better retention and fit.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because photographs are not ordinarily permitted in utility applications, and are only accepted if photographs are the only practicable medium for illustrating the claimed invention, such as photographs of cell cultures, thus new corrected drawings are required for this application. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim 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, 6-8, 10, 12, 18, 22, 23, and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over KIM et al. (referred to as “KIM”) (US 2017/0143537 A1) in view of SHIVAPUJA et al. (referred to as “SHIVAPUJA”) (US 2019/0388189 A1), as evidenced by extrinsically evidenced by Farrell (US 2011/0091833 A1) for claims 1, 7, and 23, and OZAWA et al. (referred to as “OZAWA”) (US 2015/0212440 A1) for claim 22.
Regarding claim 1, KIM discloses a mandibular advancement device (MAD) (mandibular advancement device 100) comprising an upper splint (102) and a lower splint (104) (see Fig. 1A-1B), wherein:
the upper splint (102) comprises one or more upper fins (114) (see Fig. 1A-1B; two upper fins 114 are located to the side of upper splint 102, see [0031]);
the lower splint (104) comprises one or more lower fins (116) (see Fig. 1A-1B; two lower fins 116 are located to the side of lower splint 104, see [0032]);
wherein the upper splint (102), lower splints (104), the one or more upper fins (114), and the one or more lower fins (116) comprise at least one polymeric material (PM) (see [0026]; the device 100, which comprises the upper and lower splints 102, 104 and upper fins 114 and lower fins 116, may be made of a polymeric material).
KIM is silent on wherein the upper or lower splint is configured to flex during mandibular advancement and return toward its original position after removal of force, wherein the PM having a Young’s Modulus of between about 0.5 to about 3 GPa (gigapascals), wherein PM is configured to exhibit an ability to cause the upper splint or lower splint to return to within an angle of from the original position after bending one of the upper or lower splints to a bent position for a time interval of (TI) at an angle of from an original position, wherein TI is between about 15 minutes to about 60 minutes, θ is between about 15° to about 90°, and ω is between about 1° to about 30°, wherein the returning to within the angle (ω) occurs after maintaining the bent position for the time interval (TI).
However, SHIVAPUJA teaches an analogous intraoral device (see [0126]-[0127]) and an analogous polymeric material (see [0129] lists various polymeric materials that may be used) having a Young’s Modulus of between about 0.5 to about 3 GPa (gigapascals) (see [0148] which discusses the elastic or young’s modulus of the polymeric material may be in the range of 600-2000 MPa which is equivalent to 0.6 GPa to 2.0 GPa, which is within the claimed range), providing a material with sufficient elasticity so that the device is still comfortable while also properly protecting a user’s teeth.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM to have a Young’s Modulus between 0.5 to about 3 GPa, as KIM contemplates any polymer material that can withstand the oral environment for an extended period of time, see [0026] of Kim, as taught by SHIVAPUJA to have provided an improved mandibular advancement device that provides a material with sufficient elasticity so that the device is still comfortable while also properly protecting a user’s teeth.
Therefore, the Examiner notes that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the combination of KIM in view of SHIVAPUJA renders obvious the upper splint or lower splint is configured to flex during mandibular advancement and return toward the original position after removal of force, and the PM is configured to exhibit an ability to cause the upper splint or lower splint to return to within an angle of from the original position after bending one of the upper or lower splints to a bent position for a time interval of (TI) at an angle of from an original position, wherein TI is between about 15 minutes to about 60 minutes, θ is between about 15° to about 90°, and ω is between about 1° to about 30°, wherein the returning within the angle (ω) occurs after maintaining the bent position for the time interval (TI), as the Young’s Modulus of the PM of the device of KIM in view of SHIVAPUJA is within the claimed range of 0.5 to 3 GPa, and therefore, the polymeric material of the device would act the same as the claimed invention and have enough elasticity to bend and return to its original position as claimed, so that the mandibular advancement device is more comfortable for prolonged periods of time and providing better retention and fit, as further evidenced by Farrell which discusses an analogous oral appliance that is made out of an analogous polymeric material, see [0065] of Farrell which states that the oral appliance may be made out of polyurethane, which is also one of the materials that SHIVAPUJA discloses, see [0129] of SHIVAPUJA, and is also one of the materials disclosed in applicant’s specification, see Pg. 3 line 9, and Farrell discusses how the material is resilient and thus is able to be in a bent position for a time interval and return to its original position, see [0019] of Farrell. Further, it is noted that the applicant does not provide any evidence as to the criticality, see Pg. 11 lines 30-32, Pg. 12 lines 1-12 of Applicant’s specification, and therefore, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products.
Regarding claim 6, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1.
SHIVAPUJA further teaches wherein more than about half of bonds, or between about 51% and 99% of bonds, between polymeric buildings blocks of the PM are ester bonds, carbonate bonds, or combinations thereof (see [0129] which discusses how polyester may be the polymeric material, and polyester comprises repeating ester bonds to form polyester, therefore, inherently, more than about half of bonds between polymeric building blocks of the polyester material are ester bonds), providing a polymeric material that provides flexibility and durability so that the device is comfortable for a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA to be a polyester material such that wherein more than about half of bonds, or between 51% and 99% of bonds, between polymeric building blocks of the PM are ester bonds, carbonate bonds, or a combination thereof, as KIM contemplates any polymer material that can withstand the oral environment for an extended period of time, see [0026] of KIM, to have provided an improved mandibular advancement device that provides flexibility and durability so that the device is comfortable for a user.
Regarding claim 7, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1.
Although KIM in view of SHIVAPUJA does not explicitly disclose wherein after bending one of the upper or lower splints for a time interval (TI) at an angle θ of from an original position, the upper or lower splint returns to within an angle of ω from the original position, wherein TI is between about 15 minutes to about 60 minutes, θ is between about 30° to 90°, and ω is between about 1° to about 30°, it is noted that the applicant does not provide any evidence as to the criticality, see Pg. 11 lines 30-32, Pg. 12 lines 1-12 of Applicant’s specification, and therefore, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have been able to bend one of the upper or lower splints for a time interval of TI at an angle of from the original position, wherein TI is between about 15 minutes to about 60 minutes, is between about 15 to 90, and is between about 1 to about 30, as the Young’s modulus of the polymeric material (PM) of the device of KIM in view of SHIVAPUJA is within the claimed range of about 0.5 to 3 GPa (see claim 1 above), and thus the polymeric material would have enough elasticity to bend and return to its original position as claimed, so that the mandibular advancement device is more comfortable for prolonged periods of time as the device provides better retention/fit, as further evidenced by Farrell which discusses an analogous oral appliance that is made out of an analogous polymeric material, see [0065] of Farrell which states that the oral appliance may be made out of polyurethane, which is also one of the materials that SHIVAPUJA discloses, see [0129] of SHIVAPUJA, and is also one of the materials disclosed in applicant’s specification, see Pg. 3 line 9, and Farrell discusses how the material is resilient and thus is able to be in a bent position for a time interval and return to its original position, see [0019] of Farrell.
Regarding claim 8, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 7.
Although KIM in view of SHIVAPUJA does not explicitly disclose wherein TI is between 20 minuts to about 45 minutes, it is noted that the applicant does not provide any evidence as to the criticality, see Pg. 11 lines 30-32, Pg. 12 lines 1-12 of Applicant’s specification, and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention wherein TI is between 20 minutes to about 45 minutes, as the Young’s modulus of the polymeric material (PM) of the device of KIM in view of SHIVAPUJA is within the claimed range of about 0.5 to 3 GPa (see claim 1 above), and thus the polymeric material would have enough elasticity to be bent for a time interval TI between 20 minutes to about 45 minutes as claimed, so that the mandibular advancement device is more comfortable for prolonged periods of time, as where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claim 10, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 7.
Although KIM in view of SHIVAPUJA does not explicitly disclose wherein θ is between about 30° to about 60°, or θ is between about 40° to about 50°, it is noted that the applicant does not provide any evidence as to the criticality, see Pg. 11 lines 30-32, Pg. 12 lines 1-12 of Applicant’s specification, and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention wherein θ is between about 30° to 60°, or θ is between about 40° to about 50°, as the Young’s modulus of the polymeric material (PM) of the device of KIM in view of SHIVAPUJA is within the claimed range of about 0.5 to 3 GPa (see claim 1 above), and thus the polymeric material would have enough elasticity to be bent at an angle of about 30° to about 60° or between about 40° to about 50°, so that the mandibular advancement device is more comfortable for prolonged periods of time. Further, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claim 12, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 7.
Although KIM in view of SHIVAPUJA does not explicitly disclose wherein ω is between about 5° to 20°, or ω is between about 8° to 12°, it is noted that the applicant does not provide any evidence as to the criticality, see Pg. 11 lines 30-32, Pg. 12 lines 1-12 of Applicant’s specification, and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention wherein ω is between about 5° to about 20°, or ω is between about 8° to about 12°, as the Young’s modulus of the polymeric material (PM) of the device of KIM in view of SHIVAPUJA is within the claimed range of about 0.5 to 3 GPa (see claim 1 above), and thus the polymeric material would have enough elasticity wherein the upper or lower splint would return to its original position within the claimed angles, so that the mandibular advancement device is more comfortable for prolonged periods of time. Further, Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claim 18, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1. KIM in view of SHIVAPUJA further discloses wherein the PM allows for prolonged or permanent exposure time, wherein these terms are defined in the United States Pharmacopeia and National Formulary (USP-NF) (see [0026] of KIM which discusses that any material may be used as long as the material can withstand the oral environment for an extended or prolonged period of time, and also discusses that rubber or synthetic rubber are all suitable polymeric materials for the device, and these materials allow for prolonged or permanent exposure time defined in the USP-NF, as the Applicant has also listed these materials in Applicant’s specification on Pg. 3 lines 4-13 and Pg. 11 lines 16-22).
Regarding claim 22, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1. KIM in view of SHIVAPUJA further discloses wherein the area covered by the upper splint (102) and the lower splint (104) between the gingiva and the height of contour of the MAD is at least about 1.1 times, or about 1.2 times, or about 1.4 times, or about 1.7 times, or between about 1 and 2 times, greater than a similar area covered by an MAD made of polymethylmethacrylate (PMMA) for the same patient (given that the Young’s modulus of the polymeric material is between about 0.5 GPa to about 3 GPa, as claimed in claim 1 and SHIVAPUJA teaches that the Young’s modulus of a polymeric material can be 600 MPa or 0.6 GPa, see [0148] of SHIVAPUJA, it is inherent that an area covered by the upper splint 102 and lower slint 104 between the gingiva and the height of contour of the MAD is at least about 1.1 times greater than a similar area covered by an MAD made of polymethylmethacrylate (PMMA) for the same patient, as Applicant’s specification discusses how PMMA is too stiff of a polymer and thus results in a lesser coverage, see Pg. 14 lines 6-19, and the Young’s Modulus of PMMA is said to be 3.01 GPa which is greater than 0.6 GPa, see paragraph [0156] of US 2015/0212440 A1 OZAWA as evidence, and the Young’s modulus of a material is how easily it bends/stretches and thus is related to the stiffness of a material, and therefore where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product.
Regarding claim 23, KIM teaches a method for making a mandibular advancement device (MAD) (mandibular advancement device 100) comprising an upper splint (102) and a lower splint (104) (see Fig. 1A-1B), wherein the upper splint (102) comprises one or more upper fins (114) (see Fig. 1A-1B; two upper fins 114 are located to the side of upper splint 102, see [0031]), and the lower splint (104) comprises one or more lower fins (116) (see Fig. 1A-1B; two lower fins 116 are located to the side of lower splint 104, see [0032]),
the method comprising fabricating the upper and/or lower splints (102, 104) using at least one polymeric material (PM) (see [0026]; the device 100, which comprises the upper and lower splints 102, 104, may be made of a polymeric material).
KIM is silent on the at least one polymeric material (PM) having a Young’s Modulus of between about 0.1 to about 10 GPa (gigapascals), wherein PM is configured to exhibit an ability to cause the upper splint or lower splint to return to within an angle of from the original position after bending one of the upper or lower splints for a time interval of (TI) at an angle of from an original position, wherein TI is between about 15 minutes to about 60 minutes, θ is between about 15° to about 90°, and ω is between about 1° to about 30°, wherein the returning to within the angle (ω) occurs after maintaining the bent position for the time interval (TI).
However, SHIVAPUJA teaches an analogous intraoral device (see [016]-[0127]), and an analogous polymeric material (see [0129] lists various polymeric materials that may be used) having a Young’s Modulus of between about 0.1 to about 10 GPa (gigapascals) (see [0148] which discusses the elastic or young’s modulus of the polymeric material may be in the range of 600-2000 MPa, which is equivalent to 0.6 to 2.0 GPa, which is within the claimed range), providing a material with sufficient elasticity so that the device is still comfortable while also properly protecting a user’s teeth.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM to have a Young’s Modulus between 0.1 to 10 GPa, as KIM contemplates any polymer material that can withstand the oral environment for an extended period of time, see [0026] of Kim, as taught by SHIVAPUJA to have provided an improved method for making a mandibular advancement device that provides a material with sufficient elasticity so that the device is still comfortable while also properly protecting a user’s teeth.
Therefore, the Examiner notes that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the combination of KIM in view of SHIVAPUJA renders obvious the PM is configured to exhibit an ability to cause the upper splint or lower splint to return to within an angle of from the original position after bending one of the upper or lower splints to a bent position for a time interval of (TI) at an angle of from an original position, wherein TI is between about 15 minutes to about 60 minutes, θ is between about 15° to about 90°, and ω is between about 1° to about 30°, wherein the returning within the angle (ω) occurs after maintaining the bent position for the time interval (TI), as the Young’s Modulus of the PM of the device of KIM in view of SHIVAPUJA is within the claimed range of 0.1 to 10 GPa, and therefore, the polymeric material of the device would act the same as the claimed invention and have enough elasticity to bend and return to its original position as claimed, so that the mandibular advancement device is more comfortable for prolonged periods of time and allowing for better retention and fit, as further evidenced by Farrell which discusses an analogous oral appliance that is made out of an analogous polymeric material, see [0065] of Farrell which states that the oral appliance may be made out of polyurethane, which is also one of the materials that SHIVAPUJA discloses, see [0129] of SHIVAPUJA, and is also one of the materials disclosed in applicant’s specification, see Pg. 3 line 9, and Farrell discusses how the material is resilient and thus is able to be in a bent position for a time interval and return to its original position, see [0019] of Farrell. Further, it is noted that the applicant does not provide any evidence as to the criticality, see Pg. 11 lines 30-32, Pg. 12 lines 1-12 of Applicant’s specification, and therefore, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products.
Regarding claim 42, KIM in view of SHIVAPUJA discloses the mandibular advancement device as discussed in claim 1. KIM in view of SHIVAPUJA further discloses a method for treating bruxism or a sleep-related breathing disorder (see Abstract and [0019] of KIM which discusses reducing partial constriction of airway during sleep for a patient, and see [0003] of KIM), wherein optionally the sleep-related breathing disorder is obstructive sleep apnea (OSA) or snoring, and/or TMJ disorder (see [0003], Abstract, and [0008] of KIM; the sleep-related breathing disorder is snoring and mild sleep apnea), comprising administering to an individual in need thereof a mandibular advancement device (MAD) (100 of KIM) as set forth in claim 1 (see claim 1 above, and see Figs. 1A-1B of KIM; mandibular advancement device 100 of KIM is administered to an individual in need, also see [0019] and [0066] of KIM).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over KIM in view of SHIVAPUJA further in view of Crawford et al. (referred to as “Crawford”) (US 2006/0286332 A1).
Regarding claim 2, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1.
KIM in view of SHIVAPUJA is silent on wherein the PM comprises: (a) a polymer comprising, or substantially comprising, an amorphous copolyester produced from or comprising: dimethyl terephthalate, 1,4- cyclohexanedimenthanol and 2,2,4,4,-tetremethyl-1, 3-cyclobutanediol (the amorphous copolyester designated EVO), wherein optionally the upper and lower splints are manufactured from or milled from a polymer comprising at least about 60%, 70%, 80%, 90% or 95% EVO; or (b) a copolymer derived from, or comprising, two or more species of monomer comprising, or substantially comprising, an amorphous copolyester produced from or comprising: dimethyl terephthalate, 1,4-cyclohexanedimenthanol and 2,2,4,4,- tetremethyl-1, 3-cyclobutanediol (the amorphous copolyester designated EVO), wherein optionally the upper and lower splints are manufactured from or milled from a polymer comprising at least about 40%, 50%, 60%, 70%, 80%, 90% or 95% EVO.
However, Crawford teaches an analogous polymeric material (PM) (see [0002] which describes a polymeric material), and wherein the PM comprises: (a) a polymer comprising, or substantially comprising, an amorphous copolyester produced from or comprising: dimethyl terephthalate, 1,4- cyclohexanedimenthanol and 2,2,4,4,-tetremethyl-1, 3-cyclobutanediol (the amorphous copolyester designated EVO), wherein optionally the upper and lower splints are manufactured from or milled from a polymer comprising at least about 60%, 70%, 80%, 90% or 95% EVO; or (b) a copolymer derived from, or comprising, two or more species of monomer comprising, or substantially comprising, an amorphous copolyester produced from or comprising: dimethyl terephthalate, 1,4-cyclohexanedimenthanol and 2,2,4,4,- tetremethyl-1, 3-cyclobutanediol (the amorphous copolyester designated EVO), wherein optionally the upper and lower splints are manufactured from or milled from a polymer comprising at least about 40%, 50%, 60%, 70%, 80%, 90% or 95% EVO (see [0002], [0876], [0877], and [0407]-[0420]; [0002] which discusses a polymer comprising an amorphous copolyester produced from dimethyl terephthalate, 1,4- cyclohexanedimenthanol and 2,2,4,4,-tetremethyl-1, 3-cyclobutanediol (the amorphous copolyester designated EVO), as the terephthalic acid may be dimethyl terephthalate, see [0877]), providing a polymer material with low densities, chemical resistance, hydrolytic stability, and long crystallization half-times, allowing the material to be easily formed (see [0002]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymer material in the device of KIM in view of SHIVAPUJA to be a polymer comprising, or substantially comprising, an amorphous copolyester produced from or comprising: dimethyl terephthalate, 1,4-cyclohdexanedimenthanol and 2,2,4,4,-tetremethyl-1, 3-cyclobutanediol (the amorphous copolyester designated EVO) as taught by Crawford to have provided an improved mandibular advancement device that provides a polymer material with low densities, chemical resistance, hydrolytic stability, and long crystallization half-times, allowing the material to be easily formed (see [0002]).
Claim(s) 3, 4, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over KIM in view of SHIVAPUJA further in view of Jansheski et al. (referred to as “Jansheski”) (US 2011/0067711 A1).
Regarding claim 3, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1.
KIM in view of SHIVAPUJA is silent on wherein the PM is a combination of two or more copolymers.
However, Jansheski teaches an analogous intraoral device (10,20) and an analogous polymeric material (PM), wherein the PM is a combination of two or more copolymers (see [0061]; the formable portion of the intraoral device can be formed from a resin comprising a mixture of two different ethylene vinyl acetate (EVA) copolymer: AT Plastics Ateva 4030 and Elvax 150), providing a blended material with improved processability.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material of KIM in view of SHIVAPUJA to be a combination of two or more copolymers as taught by Jansheski to have provided an improved mandibular advancement device that has a blended material with improved processability.
Regarding claim 4, KIM in view of SHIVAPUJA further in view of Jansheski discloses the invention as discussed in claim 3. KIM in view of SHIVAPUJA further in view of Jansheski further discloses wherein the copolymers are introduced, or are fabricated or situated in the MAD, or in a body of the MAD: i) at random, or ii) as block copolymers, or iii) a combination of i) and ii) (see [0061] of Jansheski; as previously modified above, the two copolymers of Jansheski are AT Plastics Ateva 4030 and Elvax 150 and they are formed as a mixture, and thus are fabricated in the body of the MAD at random, as they are not block copolymers).
Regarding claim 19, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1.
KIM in view of SHIVAPUJA is silent on wherein the PM is or comprises a polymer monolith, or the PM is or comprises a copolymer; or the PM is a copolymer derived from, or comprising, two or more species of monomer.
However, Jansheski teaches an analogous intraoral device (10,20) and an analogous polymeric material (PM), wherein the PM is or comprises a polymer monolith, or the PM is or comprises a copolymer; or the PM is a copolymer derived from, or comprising, two or more species of monomer (see [0061]; the formable portion of the intraoral device can be formed from ethylene vinyl acetate (EVA) copolymers, and thus comprises a copolymer and is a copolymer derived from two different monomers: ethylene and vinyl acetate), providing a blended material with improved processability.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA to comprise a copolymer or the PM is a copolymer derived from, or comprising, two or more species of monomer as taught by Jansheski to have provided an improved mandibular advancement device that provides a blended material with improved processability.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over KIM in view of SHIVAPUJA in view of Herzlinger et al. (referred to as “Herzlinger”) (US 2022/0233756 A1).
Regarding claim 5, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1.
KIM in view of SHIVAPUJA is silent on wherein the PM is selected from a group comprising of a Class IV polymer, a Class V polymer, a Class VI polymer and combinations thereof, wherein the Class IV polymer, a Class V polymer, a Class VI polymer are defined in Chapter 88 of the United States Pharmacopeia and National Formulary (USP-NF), and optionally the Class IV polymer, the Class V polymer, and/or the Class VI polymer comprises a medical silicone or a polysiloxane, a medical grade polypropylene polyurethane, a polycarbonate urethane, apolycarbonate-silicone urethane copolymer, a polyamine, a polyethylene terephthalate, a polycaprolactone, a polyvinyl chloride elastomer, a polyolefin homopolymeric and/or copolymeric elastomer, a urethane-based elastomer, a natural rubber or a synthetic rubber, or a mixture thereof, and the like.
However, Herzlinger teaches an analogous polymeric material (PM) (see [0168]-[0170]), and wherein the PM is selected from a group comprising of a Class IV polymer, a Class V polymer, a Class VI polymer and combinations thereof, wherein the Class IV polymer, a Class V polymer, a Class VI polymer are defined in Chapter 88 of the United States Pharmacopeia and National Formulary (USP-NF), and optionally the Class IV polymer, the Class V polymer, and/or the Class VI polymer comprises a medical silicone or a polysiloxane, a medical grade polypropylene polyurethane, a polycarbonate urethane, a polycarbonate-silicone urethane copolymer, a polyamine, a polyethylene terephthalate, a polycaprolactone, a polyvinyl chloride elastomer, a polyolefin homopolymeric and/or copolymeric elastomer, a urethane-based elastomer, a natural rubber or a synthetic rubber, or a mixture thereof, and the like (see [0170]; the polymeric material PM meets requirements for biocompatibility as set forth by the United States Pharmacopeia, and thus the polymer may be selected from a Class IV polymer, a Class V polymer, and a Class VI polymer), providing a polymer material that meets requirement for biocompatibility (see [0170]) so that the material is safe for a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material of KIM in view of SHIVAPUJA to be selected from the group consisting of a Class IV polymer, a Class V polymer, a Class VI polymer, and combinations thereof, wherein the classes are defined in Chapter 88 of the United Sates Pharmacopeia and National Formulary (USP-NF) as taught by Herzlinger to have provided an improved mandibular advancement device that meets requirement for biocompatibility (see [0170]) so that the material is safe for a user.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over KIM in view of SHIVAPUJA further in view of Koev (US 6,610,398 B1).
Regarding claim 14, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1.
KIM in view of SHIVAPUJA is silent on wherein a curve of stress versus (vs.) strain for the PM has an area under the curve that is more than about twice, or more than about 4 times, or more than about 7 times, or more than about 12 times, greater than the analogous area under the curve for upper and lower splints made of polymethylmethacrylate (PMMA).
However, Koev teaches an analogous polymeric material (polyether sulfone or PES is an analogous polymeric material), and wherein a curve of stress versus (vs.) strain for the PM has an area under the curve that is more than about twice, or more than about 4 times, or more than about 7 times, or more than about 12 times, greater than the analogous area under the curve for polymethylmethacrylate (PMMA) (see Fig. 6 and Col. 7 lines 64-67 et seq. Col. 8 lines 1-5; the stress vs. strain curve is shown in Fig. 6 of both PES and PMMA, and the PES material has a greater area under the stress vs. strain curve than PMMA material, as the PES material has a stress that goes up to about 40,000 psi while the PMMA material has a stress that goes up to about 10,000, and thus the area under the curve of the PES material is more than about twice the area of the PMMA material), providing a polymeric material that has a greater toughness so that the device is durable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA to be a polymeric material that results in a curve of stress versus (vs.) strain for the PM to have an area under the curve that is more than about twice greater than the analogous area under the curve for upper and lower splints made of polymethylmethacrylate (PMMA) as taught by Koev to have provided an improved mandibular advancement device that provides a polymeric material that has a greater toughness so that the device is durable.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over KIM in view of SHIVAPUJA further in view of Zheng et al. (referred to as “Zheng”) (US 2014/0357769 A1).
Regarding claim 15, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1.
KIM in view of SHIVAPUJA is silent on wherein the PM comprises one or more additional material(s) selected from the group consisting of reinforcing fillers, impact modifiers, tougheners, plasticizers, thermal stabilizers and combinations thereof.
However, Zheng teaches an analogous polymeric material (see Abstract which discusses a polymeric material made up of polycarbonate and polyester), and wherein the PM comprises one or more additional material(s) selected from the group consisting of reinforcing fillers, impact modifiers, tougheners, plasticizers, thermal stabilizers and combinations thereof (see [0043] and [0216]; the polymeric material comprises an additional material of at least one reinforcing filler), providing to increase the modulus and tensile strength of the material (see [0216]) so that the device is more durable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA to comprise one or more additional material(s) selected from the group consisting of reinforcing fillers as taught by Zheng to have provided an improved mandibular advancement device that provides to increase the modulus and tensile strength of the material (see [0216]) so that the device is more durable.
Regarding claim 16, KIM in view of SHIVAPUJA further in view of Zheng discloses the invention as discussed in claim 15.
Zheng further teaches wherein the PM comprises up to about 5%, or about 30%, or about 45%, or about 60%, or between about 1% and 75%, or 2% and 70%, of reinforcing fillers (see [0043]-[0044]; the polymeric material of Zheng comprises about 25wt% to 60 wt% of a reinforcing filler material, which is within the claimed range of between about 1% and 75%), providing to increase the modulus and tensile strength of the material (see [0216]) so that the device is more durable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA further in view of Koev to comprise between about 1% and 75% of reinforcing fillers as taught by Zheng to have provided an improved mandibular advancement device that provides to increase the modulus and tensile strength of the material (see [0216]) so that the device is more durable.
Regarding claim 17, KIM in view of SHIVAPUJA further in view of Zheng discloses the invention as discussed in claim 15.
Zheng further teaches wherein the PM comprises up to about 1%, or about 5%, or about 10%, or about 20%, or between about 0.5% and 25%, of impact modifiers, tougheners, or a combination thereof (see [0043] which discusses the polymeric material can further comprise an impact modifier, and [0048] discusses that the polymeric material comprises about 1wt% to about 10wt% of the impact modifier, which is about 1% , or 5%, or about 10% and within the claimed range of between about 0.5% and 25%), providing to increase the impact strength of the polymeric material so that the device is more durable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA further in view of Zheng to comprise up to about 1%, or about 5%, or about 10%, or between about 0.5% and 25% of impact modifiers as taught by Zheng to have provided an improved mandibular advancement device that increases the impact strength of the polymeric material so that the device is more durable.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over KIM in view of SHIVAPUJA further in view of Argal et al. (referred to as “Argal”) (US 2013/0109779 A1).
Regarding claim 21, KIM in view of SHIVAPUJA discloses the invention as discussed in claim 1.
KIM in view of SHIVAPUJA is silent on wherein the PM comprises less than about or no more than about 1% or less than about 0.5%, or between about 0.25% and 2% leachables.
However, Argal teaches an analogous polymeric material (see Abstract), and wherein the polymeric material comprises less than about or no more than about 1% or less than about 0.5%, or between about 0.25% and 2% leachables (see [0095] and [0222] which discusses how the polymeric material has a leachable content of less than 0.6%), providing a polymeric material that is more stable and safer to a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA to comprise less than about 1% or between about 0.25% and 2% of leachables as taught by Argal to have provided an improved mandibular advancement device that has a polymeric material that is more stable and safer to a user.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over KIM in view of SHIVAPUJA in view of Koev in view of Jansheski in view of Herzlinger in view of Zheng further in view of Argal, as evidenced by OZAWA.
Regarding claim 24, KIM in view of SHIVAPUJA discloses the method as discussed in claim 23. KIM in view of SHIVAPUJA further discloses wherein: (o) the PM allows for prolonged or permanent exposure time, wherein these terms are defined in the United States Pharmacopeia and National Formulary (USP-NF) (see [0026] of KIM which discusses that any material may be used as long as the material can withstand the oral environment for an extended or prolonged period of time, and also discusses that rubber or synthetic rubber are all suitable polymeric materials for the device, and these materials allow for prolonged or permanent exposure time defined in the USP-NF, as the Applicant has also listed these materials in Applicant’s specification on Pg. 3 lines 4-13 and Pg. 11 lines 16-22); and (r) the area covered by the upper splint and the lower splint between a gingiva and a height of the contour of the MAD is at least about 1.1 times, or about 1.2 times, or about 1.4 times, or about 1.7 times, or between about 1 and 2 times, greater than an area covered by an MAD made of polymethyl-methacrylate (PMMA) for the same patient (given that the Young’s modulus of the polymeric material is between about 0.1 GPa to about 10 GPa, as claimed in claim 1 and SHIVAPUJA teaches that the Young’s modulus of a polymeric material can be 600 MPa or 0.6 GPa, see [0148] of SHIVAPUJA, it is inherent that an area covered by the splints between the gingiva and the height of contour of the MAD is at least about 1.1 times greater than a similar area covered by an MAD made of polymethylmethacrylate (PMMA) for the same patient, as Applicant’s specification discusses how PMMA is too stiff of a polymer and thus results in a lesser coverage, see Pg. 14 lines 6-19, and the Young’s Modulus of PMMA is said to be 3.01 GPa which is greater than 0.6 GPa, see paragraph [0156] of US 2015/0212440 A1 OZAWA as evidence, and the Young’s modulus of a material is how easily it bends/stretches and thus is related to the stiffness of a material, and therefore where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product).
Although KIM in view of SHIVAPUJA does not explicitly disclose the polymeric material (PM) is selected by its ability to return to its original position when bent for a period of time, and after bending one of the upper or lower splints for a time interval of TI at an angle θ of from an original position, the upper or lower splint returns to within an angle of ω from the original position; the time interval TI for the MAD to return to its original position, or to substantially approximately return to its original position, when bent for a period time, is between about 15 minutes to about 60 minutes, or TI is between about 20 minutes to about 45 minutes, or TI is between about 30 minutes to about 35 minutes; θ is between about 15° to 90°, or θ about 30° to about 60°, or θ is between about 40° to about 50°; and ω is between about 1° and to about 30°, or ω between about 5° to about 20°, or ω is between about 8° to about 12°, it is noted that the applicant does not provide any evidence as to the criticality, see Pg. 11 lines 30-32, Pg. 12 lines 1-12 of Applicant’s specification, and therefore, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the polymeric material by its ability to return to its original position when bent for a period of time, and to have been able to bend one of the upper or lower splints for the time interval TI for the MAD to return to its original position, or to substantially approximately return to its original position, when bent for a period time, is between about 15 minutes to about 60 minutes, or TI is between about 20 minutes to about 45 minutes, or TI is between about 30 minutes to about 35 minutes; θ is between about 15° to 90°, or θ about 30° to about 60°, or θ is between about 40° to about 50°; and ω is between about 1° and to about 30°, or ω between about 5° to about 20°, or ω is between about 8° to about 12°, as the Young’s modulus of the polymeric material (PM) of the device of KIM in view of SHIVAPUJA is within the claimed range of about 0.1 to 10 GPa (see claim 1 above) (SHIVAPUJA discloses a Young’s Modulus of 0.6 GPa to 2 GPa, see [0148] of SHIVAPUJA), and thus the polymeric material would have enough elasticity to bend and return to its original position angle as claimed, so that the mandibular advancement device is more comfortable for prolonged periods of time.
KIM in view of SHIVAPUJA is silent on a curve of stress versus strain for the polymeric material (PM) has an area under the curve that is more than about twice, or more than about 4 times, or more than about 7 times, or more than about 12 times, greater than an analogous area under a curve for upper and lower splints made of polymethyl-methacrylate (PMMA).
However, Koev teaches an analogous polymeric material (polyether sulfone or PES is an analogous polymeric material), and wherein a curve of stress versus (vs.) strain for the PM has an area under the curve that is more than about twice, or more than about 4 times, or more than about 7 times, or more than about 12 times, greater than an analogous area under the curve for polymethylmethacrylate (PMMA) (see Fig. 6 and Col. 7 lines 64-67 et seq. Col. 8 lines 1-5; the stress vs. strain curve is shown in Fig. 6 of both PES and PMMA, and the PES material has a greater area under the stress vs. strain curve than PMMA material, as the PES material has a stress that goes up to about 40,000 psi while the PMMA material has a stress that goes up to about 10,000, and thus the area under the curve of the PES material is more than about twice the area of the PMMA material), providing a polymeric material that has a greater toughness so that the device is durable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA to be a polymeric material that results in a curve of stress versus (vs.) strain for the PM to have an area under the curve that is more than about twice greater than an analogous area under the curve for upper and lower splints made of polymethylmethacrylate (PMMA) as taught by Koev to have provided an improved method of making a mandibular advancement device that provides a polymeric material that has a greater toughness so that the device is durable.
KIM in view of SHIVAPUJA further in view of Koev discloses the invention as discussed above.
KIM in view of SHIVAPUJA further in view of Koev is silent on the PM is a copolymer derived from, or comprising, two or more species of monomer, or, the PM is a combination of, or comprises, two or more copolymers; copolymers are introduced, or are fabricated or situated in the MAD, or mixed in a body of the MAD: i) at random, ii) as block copolymers, or iii) a combination of i) and ii); and the PM is or comprises a polymer monolith, or the PM is or comprises a copolymer and/or a copolymer derived from, or comprising, two or more species of monomer.
However, Jansheski teaches an analogous intraoral device (10,20) and an analogous polymeric material (PM), wherein the PM is a copolymer derived from, or comprising, two or more species of monomer, or, the PM is a combination of, or comprises, two or more copolymers (see [0061]; the formable portion of the intraoral device can be formed from a resin comprising a mixture of two different ethylene vinyl acetate (EVA) copolymer: AT Plastics Ateva 4030 and Elvax 150, and thus the polymeric material comprises two monomers: ethylene and vinyl acetate, and also comprises two or more copolymers), and copolymers are introduced, or are fabricated or situated in the MAD, or mixed in the body of the MAD: i) at random, ii) as block copolymers, or iii) a combination of i) and ii) (see [0061]; the two copolymers AT Plastics Ateva 4030 and Elvax 150 are formed as a mixture and thus are fabricated in the body of the device at random, as they are not block copolymers); and the PM is or comprises a copolymer and/or a copolymer derived from, or comprising, two or more species of monomer (see [0061]; the polymer material is a copolymer and is derived from ethylene and vinyl acetate which are two monomers), providing a blended material with improved processability.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material of KIM in view of SHIVAPUJA further in view of Koev to be a copolymer derived from, or comprising, two or more species of monomer, or the PM is a combination of, or comprises two or more copolymers, and the copolymers are introduced, or fabricated, or situated in the MAD, or mixed in the body of the MAD at random as taught by Jansheski to have provided have provided an improved method of making a mandibular advancement device that has a blended material with improved processability.
KIM in view of SHIVAPUJA in view of Koev further in view of Jansheski discloses the invention as discussed above.
KIM in view of SHIVAPUJA in view of Koev further in view of Jansheski is silent on the PM is selected from a group comprising a Class IV polymer, a Class V polymer, a Class VI polymer, and combinations thereof, wherein the Class IV polymer, a Class V polymer, a Class VI polymer are defined in Chapter 88 of the United States Pharmacopeia and National Formulary (USP-NF), and optionally the Class IV polymer, the Class V polymer, and/or the Class VI polymer comprises a medical silicone or a polysiloxane, a medical grade polypropylene, polyurethane, a polycarbonate urethane, a polycarbonate-silicone urethane copolymer, a polyamine, a polyethylene terephthalate, a polycaprolactone, a polyvinyl chloride elastomer, a polyolefin homopolymer and/or copolymeric elastomer, a urethane-based elastomer, a natural rubber or a synthetic rubber, or a mixture thereof.
However, Herzlinger teaches an analogous polymeric material (PM) (see [0168]-[0170]), and wherein the PM is selected from a group comprising of a Class IV polymer, a Class V polymer, a Class VI polymer and combinations thereof, wherein the Class IV polymer, a Class V polymer, a Class VI polymer are defined in Chapter 88 of the United States Pharmacopeia and National Formulary (USP-NF), and optionally the Class IV polymer, the Class V polymer, and/or the Class VI polymer comprises a medical silicone or a polysiloxane, a medical grade polypropylene polyurethane, a polycarbonate urethane, a polycarbonate-silicone urethane copolymer, a polyamine, a polyethylene terephthalate, a polycaprolactone, a polyvinyl chloride elastomer, a polyolefin homopolymeric and/or copolymeric elastomer, a urethane-based elastomer, a natural rubber or a synthetic rubber, or a mixture thereof, and the like (see [0170]; the polymeric material PM meets requirements for biocompatibility as set forth by the United States Pharmacopeia, and thus the polymer may be selected from a Class IV polymer, a Class V polymer, and a Class VI polymer), providing a polymer material that meets requirement for biocompatibility (see [0170]) so that the material is safe for a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material of KIM in view of SHIVAPUJA in view of Koev further in view of Jansheski to be selected from a group comprising of a Class IV polymer, a Class V polymer, a Class VI polymer, and combinations thereof, wherein the Class IV polymer, a Class V polymer, a Class VI polymer are defined in Chapter 88 of the United Sates Pharmacopeia and National Formulary (USP-NF) as taught by Herzlinger to have provided an improved mandibular advancement device that meets requirement for biocompatibility (see [0170]) so that the material is safe for a user.
KIM in view of SHIVAPUJA in view of Koev in view of Jansheski further in view of Herzlinger discloses the invention as discussed above.
KIM in view of SHIVAPUJA in view of Koev in view of Jansheski further in view of Herzlinger is silent on more than about half of bonds, or between about 51% to 99% of bonds, between polymeric building blocks of the PM are ester bonds, carbonate bonds, or a combination thereof.
However, SHIVAPUJA further teaches wherein more than about half of bonds, or between about 51% and 99% of bonds, between polymeric buildings blocks of the PM are ester bonds, carbonate bonds, or combinations thereof (see [0129] which discusses how polyester may be the polymeric material, and polyester comprises repeating ester bonds to form polyester, therefore, inherently, more than about half of bonds between polymeric building blocks of the polyester material are ester bonds), providing a polymeric material that provides flexibility and durability so that the device is comfortable for a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA in view of Koev in view of Jansheski further in view of Herzlinger to be a polyester material such that wherein more than about half of bonds, or between 51% and 99% of bonds, between polymeric building blocks of the PM are ester bonds, carbonate bonds, or a combination thereof, as KIM contemplates any polymer material that can withstand the oral environment for an extended period of time, see [0026] of KIM, to have provided an improved mandibular advancement device that provides flexibility and durability so that the device is comfortable for a user.
KIM in view of SHIVAPUJA in view of Koev in view of Jansheski further in view of Herzlinger discloses the invention as discussed above.
KIM in view of SHIVAPUJA in view of Koev in view of Jansheski further in view of Herzlinger is silent on the PM comprises one or more additional material(s) selected from a group comprising reinforcing fillers, impact modifies, tougheners, plasticizers, thermal stabilizers and combinations thereof; the PM comprises up to about 5%, or about 30%, or about 45%, or about 60%, or between about 1% and 75%, or 2% and 70%, of reinforcing fillers; the PM comprises up to about 5%, or about 10%, or about 20%, or between about 0.5% and 25%, of impact modifies, tougheners or a combination thereof.
However, Zheng teaches an analogous polymeric material (see Abstract which discusses a polymeric material made up of polycarbonate and polyester), and wherein the PM comprises one or more additional material(s) selected from a group comprising reinforcing fillers, impact modifiers, tougheners, plasticizers, thermal stabilizers and combinations thereof (see [0043] and [0216]; the polymeric material comprises an additional material of at least one reinforcing filler or impact modifier), the PM comprises up to about 5%, or about 30%, or about 45%, or about 60%, or between about 1% and 75%, or 2% and 70%, of reinforcing fillers (see [0043]-[0044]; the polymeric material of Zheng comprises about 25wt% to 60 wt% of a reinforcing filler material, which is within the claimed range of between about 1% and 75%), the PM comprises up to about 1%, or about 5%, or about 10%, or about 20%, or between about 0.5% and 25%, of impact modifiers, tougheners, or a combination thereof (see [0043] which discusses the polymeric material can further comprise an impact modifier, and [0048] discusses that the polymeric material comprises about 1wt% to about 10wt% of the impact modifier, which is about 1% , or 5%, or about 10% and within the claimed range of between about 0.5% and 25%), providing to increase the modulus and tensile strength of the material (see [0216]) and to increase the impact strength of the polymeric material so that the device is more durable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA in view of Koev in view of Jansheski further in view of Herzlinger to comprise one or more additional material(s) selected from a group comprising of reinforcing fillers, impact modifies, tougheners, plasticizers, thermal stabilizers and combinations thereof; the PM comprises up to about 5%, or about 30%, or about 45%, or about 60%, or between about 1% and 75%, or 2% and 70%, of reinforcing fillers; the PM comprises up to about 5%, or about 10%, or about 20%, or between about 0.5% and 25%, of impact modifies, tougheners or a combination thereof as taught by Zheng to have provided an improved method of making a mandibular advancement device that increases the modulus and tensile strength of the material (see [0216]) and increases the impact strength of the polymeric material so that the device is more durable.
KIM in view of SHIVAPUJA in view of Koev in view of Jansheski in view of Herzlinger further in view of Zheng discloses the invention as discussed above.
KIM in view of SHIVAPUJA in view of Koev in view of Jansheski in view of Herzlinger further in view of Zheng is silent on the PM comprises less than about (or no more than about) 1% or less than about 0.5% or between about 0.25% and 2% of leachables and/or the method further comprises calculating a needed spring constant (k) required for MAD and choosing a PM that exhibits that spring constant.
However, Argal teaches an analogous polymeric material (see Abstract), and wherein the polymeric material comprises less than about (or no more than about) 1% or less than about 0.5%, or between about 0.25% and 2% leachables (see [0095] and [0222] which discusses how the polymeric material has a leachable content of less than 0.6%), providing a polymeric material that is more stable and safer to a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polymeric material in the device of KIM in view of SHIVAPUJA in view of Koev in view of Jansheski in view of Herzlinger further in view of Zheng to comprise less than about 1% or between about 0.25% and 2% of leachables as taught by Argal to have provided an improved mandibular advancement device that has a polymeric material that is more stable and safer to a user.
Conclusion
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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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