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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/06/2024 has been considered by the examiner.
Response to Amendment
The amendment filed 06/16/2026 has been entered. Currently, claims 1-20 remain pending in the application. Independent claims 1 was amended by Applicant without the addition of new matter. Additionally, claims 2 has been cancelled, but the subject matter has been introduced into claims 1, ultimately changing the scope of claim 1. Additionally, the claims, specification, and drawings have all been amended to overcome previous objections set forth in the Non-Final Office Action mailed 03/16/2026. Additionally, new claims 13-20 have been added without the addition of new matter. Lastly, a new claim objection and 35 USC 112(D) rejection remains below.
Response to Arguments
Applicant's arguments filed 06/16/2026 have been fully considered but they are not persuasive. Applicant’s amendment to claim 1 of inserting the subject matter of cancelled claim 2, has overcome the previous 35 USC 102 rejection for claim 1. However, amended claim 1 is now rejected under 35 USC 103 based on the previous 35 USC 103 rejection for the original claims 2 and 10. The new rejection written below includes the current and new prior art of record: Hernandez (U.S. Patent Pub. No. 20110226261), Meade (U.S. Patent No. 6055986), Webster et al. (U.S. Patent Pub. No. 20130098372), Magnin (EP Patent No. 3167852), Oxman et al. (U.S. Patent No. 5415544), Fallon et al. (U.S. Patent Pub. No. 20120145166), and Carter (U.S. Patent No. 6099304).
4. Applicant makes the argument that “Applicant will file a terminal disclaimer upon indication of allowability” (Remarks, Page 8).
In response to Applicant’s argument (Remarks, Page 8), the double patenting rejections for claims 1 and 3-12 remains until distinguishing amended claims or a terminal disclaimer is filed for that claim set. Examiner notes that claims 13-20 are not given double patenting as they are method claims that distinguish from the apparatus parent patent.
5. Applicant makes the argument that “Meade’s adjustment uses plates that are embedded in the resilient semi-rigid material, which is fundamentally different from guides positioned in channels as recited in claim 1” (Remarks, Page 10, Paragraph 2).
In response to Applicant’s argument (Remarks, Page 10, Paragraph 2), Meade’s embedded plate block 152,156 154,158 are embedded in the layer thereby the layer is construed as forming a 3-sided channel around the plate block 152,156 154,158. Examiner notes that Applicant’s channel length is greater and the guide is just a small piece in the channel, as opposed to Meade’s plate block taking up the entire channel space. However, these differences are not recited in the claims to teach away from Meade. Overall, Examiner notes that Applicant may amend the claims to potentially overcome the current and new prior art of record by reciting positive limitations such as the channel and guide lengths and size, the spacer locations relative to the channels and guides, and any other relative structural positional relationships. Furthermore, any negative limitation such as –not—or –without— to teach away from the prior art. Lastly, transitional phrases such as –consisting— or ---consisting essentially of-- in the preamble or body of the claim to prevent prior art combinations.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10 depends on claim 2, but because claim 2 has been cancelled claim 10 is objected as incomplete, see MPEP 7.36.01(V). For examination purposes, claim 16 is made to depend from claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites the same limitations as claim 1 without further narrowing the claim scope. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
8. The term “relatively rigid” in claim 1 is defined as “a structural shape and will not deform or melt when heated or submerged in hot water” (Specification, Paragraph 25).
Double Patenting
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
10. Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, and 8 of U.S. Patent No. 12201549.
Regarding claim 1 of this child instant application, the parent U.S. Patent No. 12201549 claim 1 discloses a mouthpiece comprising:an upper guard configured to fit over the upper teeth or gum of a user, the upper guard comprising a first mold layer forming a top surface and a first shell layer forming a bottom surface, the upper guard having an arcuate shape between a first end on a first side and a second end on a second side;a lower guard configured to fit over the lower teeth or gum of the user, the lower guard comprising a second mold layer forming a top surface and a second shell layer forming a bottom surface, the lower guard having an arcuate shape between a third end on a third side and a fourth end on a fourth side;a first connector coupling the first end of the upper guard and the third end of the lower guard; anda second connector coupling the second end of the upper guard and the fourth end of the lower guard, wherein the first connector and the second connector are flexible to allow the upper guard to fold over the lower guard in a closed position,wherein the first and second mold layer are a flexible material and the first and second shell layer are a relatively rigid material[[.]]; anda first adjustable assembly comprising: a first guide positioned in a first channel in the bottom surface of the upper guard on the first side; a second guide positioned in a second channel in the bottom surface of the lower guard on the third side; and a first screw configured to engage the first guide and the second guide to adjust the respective positions of the upper guard and the lower guard when the mouthpiece is in the closed position; anda second adjustable assembly comprising: a third guide positioned in a third channel in the bottom surface of the upper guard on the second side; a fourth guide positioned in a fourth channel in the bottom surface of the lower guard on the fourth side; and a second screw configured to engage the third guide and the fourth guide to adjust the respective positions of the upper guard and the lower guard when the mouthpiece is in the closed position.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claim 1 of patent 12201549 lies in the fact that the patented claims include many more elements and is thus much more specific. Thus, the invention of claim 1 of patent 12201549 in effect a “species” of the “generic” invention of current application claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the current application is anticipated by claim 1 of patent 12201549, it is not patentably distinct from claim 1 of patent 12201549.
All of the limitations of claim 3 can be found in claim 1 of U.S. Patent No. 12201549.
All of the limitations of claim 4 can be found in claim 5 of U.S. Patent No. 12201549.
All of the limitations of claim 5 can be found in claim 6 of U.S. Patent No. 12201549.
All of the limitations of claim 6 can be found in claim 1 of U.S. Patent No. 12201549.
All of the limitations of claim 7 can be found in claim 1 of U.S. Patent No. 12201549.
All of the limitations of claim 8 can be found in claim 7 of U.S. Patent No. 12201549.
All of the limitations of claim 9 can be found in claim 1 of U.S. Patent No. 12201549.
All of the limitations of claim 10 can be found in claim 1 of U.S. Patent No. 12201549.
All of the limitations of claim 11 can be found in claim 8 of U.S. Patent No. 12201549.
This is a nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 103
11. 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.
Claims 1, 4-7, 10-11, 13-14, 16-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (U.S. Patent Pub. No. 20110226261) in view of Meade (U.S. Patent No. 6055986).
Regarding claim 1, Hernandez discloses a mouthpiece 10 (Paragraph 12 and Figures 1-3, mouthpiece 10 for treating sleep apnea via adjustment of lower guard 14 relative to upper guard 12) comprising: an upper guard 12 (Paragraph 12 and Figure 3, upper guard 12 for treating the upper dentition of a user) configured to fit over the upper teeth or gum of a user, the upper guard 12 having an arcuate shape (Figure 3, upper guard 12 has an arcuate shape to fit a user’s upper teeth arch) between a first end (Paragraph 13 and Figure 2-3, left rear portion of upper guard 12 connected to connector 16) on a first side (Figures 2-3, left side of upper guard 12) and a second end (Paragraph 13 and Figures 2-3, right rear portion of upper guard 12 connected to connector 18) on a second side (Figures 2-3, right side of upper guard 12); a lower guard 14 (Paragraph 12 and Figure, lower guard 14 for treating the lower dentition of a user) configured to fit over the lower teeth or gum of the user, the lower guard 14 having an arcuate shape (Figure 3, lower guard 14 has an arcuate shape to fit a user’s lower teeth arch) between a third end (Paragraph 15 and Figures 2-3, left rear portion of lower guard 14 connected to connector 16) on a third side (Figures 2-3, left side of lower guard 14) and a fourth end (Paragraph 15 and Figure 2-3, right rear portion of lower guard 14 connected to connector 18) on a fourth side (Figure 1, right side of lower guard 14); a first connector 16 (Paragraph 12 and Figure 1, flexible connector 16) coupling the first end of the upper guard 12 and the third end of the lower guard 14; and a second connector 18 (Paragraph 12 and Figure 1, flexible connector 18) coupling the second end of the upper guard 12 and the fourth end of the lower guard 14, wherein the first connector 16 and the second connector 18 are flexible to allow the upper guard 12 to fold over the lower guard 14 in a closed position (Paragraph 21, when upper guard 12 is placed over the lower guard 14; a first adjustable assembly 20,24 (Paragraph 19 and Figure 1) comprising: a first guide 20 (Paragraphs 19-20 and Figure 1, block 20 connected to bottom surface of upper guard 12 on left side) fixed to the bottom surface of the upper guard 12 on the first side; a second guide 24 (Paragraph 19 and Figure 1, block 24 connected to bottom surface of the lower guard 14 on left side) fixed to the bottom surface of the lower guard on the third side; and a first screw 54 (Paragraph 19 and Figure 1, first screw 19) configured to engage(Paragraph 21 and Figure 1, first screw 54 is placed through the non-threaded hole of block 20 and then fastened into the threaded hole of block 24) the first guide 20 and the second guide 24 to adjust the respective positions (Paragraph 21 and Figure 1, The position of the pointer 60 relative to the parallel ridges on the side panel of block 24 indicates how much the first screw 54 is fastened into the threaded hole of block 24, which allows the user to know how much the lower arch 14 is moved forward with respect to the upper arch 12) of the upper guard 12 and the lower guard 14 when the mouthpiece 10 is in the closed position; and a second adjustable assembly 22,26 (Paragraph 22 and Figure 1) comprising: a third guide 22 (Paragraph 22 and Figure 1, block 22 fixed to bottom surface of upper guard 12 on right side) fixed to the bottom surface of the upper guard 12 on the second side; a fourth guide26 (Paragraph 22 and Figure 1, block 26 fixed to bottom surface of lower guard 14 on right side) fixed to the bottom surface of the lower guard 14 on the fourth side; and a second screw 56 (Paragraph 22 and Figure 1, second screw 56) configured to engage (Paragraph 21 and Figure 1, first screw 54 is placed through the non-threaded hole of block 20 and then fastened into the threaded hole of block 24) the first guide 20 and the second guide 24 to adjust the respective positions (Paragraph 21 and Figure 1, The position of the pointer 60 relative to the parallel ridges on the side panel of block 24 indicates how much the first screw 54 is fastened into the threaded hole of block 24, which allows the user to know how much the lower arch 14 is moved forward with respect to the upper arch 12) of the upper guard 12 and the lower guard 14 when the mouthpiece 10 is in a closed position (Paragraph 21, when upper guard 12 is placed over the lower guard 14).
However, Hernandez fails to explicitly disclose the upper guard comprising a first mold layer forming a top surface and a first shell layer forming a bottom surface; the lower guard comprising a second mold layer forming a top surface and a second shell layer forming a bottom surface; wherein the first and second mold layer are a flexible material and the first and second shell layer are a relatively rigid material; wherein: the first guide is positioned in a first channel in the bottom surface of the upper guard; the second guide is positioned in a second channel in the bottom surface of the lower guard; the third guide is positioned in a third channel in the bottom surface of the upper guard; and the fourth guide is positioned in a fourth channel in the bottom surface of the lower guard.
Meade teaches an analogous mouthpiece 10 (Col. 7, lines 20-21, mouthpiece 10 is provided with upper 120 and lower platforms 130 which are positioned and protect a wearer’s teeth) wherein the analogous upper guard comprising a first mold layer 142 (Col. 9, lines 56-65, the upper member 120 comprises a resin layer 142 forming a top surface, wherein the resin layer 142 is formed of a material which can be easily molded in the user's mouth) forming a top surface and a first shell layer 128 (Col. 9, line 41, first shell layer of upper member 120 is defined by an upper platform floor 128) forming a bottom surface; the analogous lower guard comprising a second mold layer 144 (Col. 9, lines 56-65, the lower member 130 comprises a resin layer 144 forming a top surface, wherein the resin layer 142 are formed of a material which can be easily molded in the user's mouth) forming a top surface and a second shell layer 138 (Col. 9, line 41, second shell layer of lower member 130 is defined by a lower platform floor 138) forming a bottom surface; wherein the first 142 and second 144 mold layer are a flexible material (Col. 9, lines 56-65, resin layers 142 and 144 are formed from a flexible ethylene-vinyl acetate copolymer resin thermoplastic) and the first 128 and second 138 shell layer are a relatively rigid material (Col. 9, lines 35-39, the shell layers 128, 138 of the upper member 120 and lower member 130 are made from a resilient semi-rigid polycarbonate resin thermoplastic that has a specific gravity of about 1.20, a tensile strength yield of about 9000 and a softening temperature of about 310 degrees Fahrenheit).
Meade further teaches an analogous mouthpiece 10 (Col. 7, lines 20-21, mouthpiece 10 is provided with upper 120 and lower platforms 130 which are positioned and protect a wearer’s teeth) wherein an analogous first adjustable assembly 156,158,160 (Col. 12, lines 1-5 and Figure 1, blocks 156 and 158 for receiving longitudinal screw 160 on a left side of the upper member 120 and lower member 130, for controlling the forward and backward movement of the upper member 120 with respect to the lower member 130) wherein: the analogous first guide is positioned in a first channel (Col. 12, lines 1-5, since the left upper plate 152 and block 156 of the first guide is embedded in the upper member 120, the first guide is thereby positioned in a first channel in the bottom surface the upper member) in the analogous bottom surface (Col. 12, lines 1-7, upper plate 152 is embedded in the resilient semi-rigid material or shell layer of the upper member 120; Figure 8, upper plate 152 fixed to the bottom surface or shell layer of the upper member 120 on the left side of the upper member 120) of the analogous upper guard 120; the analogous second guide 154,158 is positioned in a second channel(Col. 12, lines 1-5, since the left lower plate 154 and block 158 of the second guide is embedded in the lower member 130, the second guide is thereby positioned in a second channel in the bottom surface the lower member 130) in the analogous bottom surface (Col. 12, lines 1-7, lower plate 154 is embedded in the resilient semi-rigid material or shell layer of the lower member 130; Figure 8, lower plate 154 fixed to the bottom surface or shell layer of the lower member 130 on the left side of the lower member 130) of the analogous lower guard 130; wherein the analogous third guide 152,156 is positioned in a third channel(Col. 12, lines 1-5, since the right upper plate 152 and block 156 of the third guide is embedded in the upper member 120, the third guide is thereby positioned in a third channel in the bottom surface the upper member) in the analogous bottom surface of the analogous upper guard 120; and the analogous fourth guide 154,158 is positioned in a fourth channel (Col. 12, lines 1-5, since the right lower plate 154 and block 158 of the fourth guide is embedded in the lower member 130, the fourth guide is thereby positioned in a fourth channel in the bottom surface the lower member 130) in the analogous bottom surface of the analogous lower guard 130.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the upper guard and lower guard of Hernandez, so that there is a first mold layer forming a top surface and a first shell layer forming a bottom surface; the lower guard comprising a second mold layer forming a top surface and a second shell layer forming a bottom surface; wherein the first and second mold layer are a flexible material and the first and second shell layer are a relatively rigid material, as taught by Meade, in order to provide an improved mouthpiece with enhanced upper and lower guards having a flexible and rigid layer for increased geometric conformance and support for a user’s upper and lower teeth, with the capability of being heated and softened to comfortably fit a user’s dental shape (Meade, Col. 9, lines 56-65).
Additionally, it would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the bottom surfaces of the upper and lower guards of Hernandez, so that the first guide is positioned in a first channel in the bottom surface of the upper guard; the second guide is positioned in a second channel in the bottom surface of the lower guard; the third guide is positioned in a third channel in the bottom surface of the upper guard; and the fourth guide is positioned in a fourth channel in the bottom surface of the lower guard, as taught by Meade, in order to provide an improved mouthpiece with upper and lower guards having channels allowing for an embedded configuration between the guards and guides, ultimately providing a space and secure connection to facilitate mandibular advancement (Meade, Col. 12, lines 1-7).
Regarding claim 4, the combination of Hernandez in view of Meade discloses the invention a as described above and further discloses wherein the first 142 (Meade, Col. 9, lines 56-65, the upper member 120 comprises a resin layer 142 forming a top surface, wherein the resin layer 142 is formed of a material which can be easily molded in the user's mouth) and second mold layers 144 (Meade, Col. 9, lines 56-65, the lower member 130 comprises a resin layer 144 forming a top surface, wherein the resin layer 142 are formed of a material which can be easily molded in the user's mouth) are configured to allow a user to form teeth impressions (Meade, Col. 9, lines 56-65, resin layers 142 and 144 are formed from ethylene-vinyl acetate copolymer resin which is heated to easily mold a user’s teeth impressions) therein after the mouthpiece has been heated (Meade, Col. 9, lines 56-65, resin layers 142 and 144 have a softening and molding temperature of about 150 degrees Fahrenheit).
Regarding claim 5, the combination of Hernandez in view of Meade further discloses wherein the first 128 (Meade, Col. 9, line 41, first shell layer of upper member 120 is defined by an upper platform floor 128) and second shell layer 138 (Meade, Col. 9, line 41, second shell layer of lower member 130 is defined by a lower platform floor 138) are configured to maintain a rigid structural shape (Meade, Col. 9, lines 35-39, the shell layers 128, 138 of the upper member 120 and lower member 130 are made from a resilient semi-rigid polycarbonate resin thermoplastic that has a specific gravity of about 1.20, a tensile strength yield of about 9000 and a softening temperature of about 310 degrees Fahrenheit) when the mouthpiece is heated (Meade, Col. 9, lines 56-65, when the mouthpiece is heated to 150 degrees Fahrenheit the resin layers 142 and 144 are molded on the teeth impression, but the shell layers 128, 138 remain structurally rigid as the shell layers do not soften until 310 degrees Fahrenheit).
Regarding claim 6, the combination of Hernandez in view of Meade further discloses the first 142 (Meade, Col. 9, lines 56-65, the upper member 120 comprises a resin layer 142 forming a top surface, wherein the resin layer 142 is formed of a material which can be easily molded in the user's mouth) and second mold layer 144 (Meade Col. 9, lines 56-65, the lower member 130 comprises a resin layer 144 forming a top surface, wherein the resin layer 142 are formed of a material which can be easily molded in the user's mouth) are a flexible thermoplastic (Col. 9, lines 56-65, resin layers 142 and 144 are formed from a flexible ethylene-vinyl acetate copolymer resin thermoplastic).
Regarding claim 7, the combination of Hernandez in view of Meade further discloses the first 142 (Meade, Col. 9, lines 56-65, the upper member 120 comprises a resin layer 142 forming a top surface, wherein the resin layer 142 is formed of a material which can be easily molded in the user's mouth) and second mold layer 144 (Meade Col. 9, lines 56-65, the lower member 130 comprises a resin layer 144 forming a top surface, wherein the resin layer 142 are formed of a material which can be easily molded in the user's mouth) are ethylene vinyl acetate (Col. 9, lines 56-65, resin layers 142 and 144 are formed from a flexible ethylene-vinyl acetate copolymer resin thermoplastic).
Regarding claim 10, the combination of Hernandez in view of Meade discloses the invention as described above and further discloses wherein: the first guide is positioned in a first channel (Meade: Col. 12, lines 1-5, since the left upper plate 152 and block 156 of the first guide is embedded in the upper member 120, the first guide is thereby positioned in a first channel in the bottom surface the upper member) in the bottom surface (Meade: Col. 12, lines 1-7, upper plate 152 is embedded in the resilient semi-rigid material or shell layer of the upper member 120; Figure 8, upper plate 152 fixed to the bottom surface or shell layer of the upper member 120 on the left side of the upper member 120) of the upper guard ; the second guide is positioned in a second channel(Meade: Col. 12, lines 1-5, since the left lower plate 154 and block 158 of the second guide is embedded in the lower member 130, the second guide is thereby positioned in a second channel in the bottom surface the lower member 130) in the bottom surface (Meade: Col. 12, lines 1-7, lower plate 154 is embedded in the resilient semi-rigid material or shell layer of the lower member 130; Figure 8, lower plate 154 fixed to the bottom surface or shell layer of the lower member 130 on the left side of the lower member 130) of the lower guard; wherein the analogous third guide is positioned in a third channel(Meade: Col. 12, lines 1-5, since the right upper plate 152 and block 156 of the third guide is embedded in the upper member 120, the third guide is thereby positioned in a third channel in the bottom surface the upper member) in the bottom surface of the upper guard; and the fourth guide is positioned in a fourth channel (Meade: Col. 12, lines 1-5, since the right lower plate 154 and block 158 of the fourth guide is embedded in the lower member 130, the fourth guide is thereby positioned in a fourth channel in the bottom surface the lower member 130) in the bottom surface of the lower guard.
Regarding claim 11, the combination of Hernandez in view of Meade discloses the invention as described above. Hernandez further discloses wherein:the top surface of the upper guard includes an inner wall and an outer wall defining a trough 31 (Paragraph 13 and Figure 3, trough 31) ; andthe top surface of the lower guard includes an inner wall and an outer wall defining a trough 36 (Paragraph 15 and Figure 3, trough 31).
Regarding claim 13, Hernandez discloses a method of reducing snoring, comprising: a hardened mouthpiece 10 (Paragraphs 12, 29and Figures 1-3, thermoplastic hardened mouthpiece 10 for treating sleep apnea via adjustment of lower guard 14 relative to upper guard 12) , actuating an adjustable assembly 20,24 22,26 (Paragraphs 19, 21 and Figure 1, The position of the pointer 60 relative to the parallel ridges on the side panel of block 24 indicates how much the first/left screw 54 is fastened into the threaded hole of block 24, which allows the user to know how much the lower arch 14 is moved forward with respect to the upper arch 12. Similar with second screw 56 on right side) to reposition a lower guard 14 of the mouthpiece relative to an upper guard 12 of the mouthpiece to advance a mandible of the user.
However, Hernandez fails to explicitly disclose heating the mouthpiece to soften a moldable layer of the mouthpiece while a structural layer of the mouthpiece maintains a structural shape of the mouthpiece; forming a customized dental interface by molding the moldable layer against dentition of a user; allowing the moldable layer to harden to retain the customized dental interface; and after the moldable layer has hardened.
Meade teaches an analogous mouthpiece 10 (Col. 7, lines 20-21, mouthpiece 10 is provided with upper 120 and lower platforms 130 which are positioned and protect a wearer’s teeth) comprising heating (Col. 9, lines 56-65, resin layers 142 and 144 have a softening and molding temperature of about 150 degrees Fahrenheit) the analogous mouthpiece to soften a moldable layer 142,144 (Col. 9, lines 56-65, the upper member 120 comprises a resin layer 142 forming a top surface, wherein the resin layer 142 is formed of a material which can be easily molded in the user's mouth. The lower member 130 comprises a resin layer 144 forming a top surface, wherein the resin layer 142 are formed of a material which can be easily molded in the user's mouth) of the analogous mouthpiece while a structural layer 128,138 (Col. 9, line 41, first shell layer of upper member 120 is defined by an upper platform floor 128. Second shell layer of lower member 130 is defined by a lower platform floor 138) of the analogous mouthpiece maintains a structural shape of the analogous mouthpiece; forming a customized dental interface (Col. 9, lines 56-65, resin layers 142 and 144 are formed from ethylene-vinyl acetate copolymer resin which is heated to easily mold a user’s teeth impressions) by molding the moldable layer against dentition of a user; allowing the moldable layer142,144 to harden to retain the customized dental interface.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the upper guard and lower guard of the mouthpiece of Hernandez, so that heating there is a softening of a moldable layer of the mouthpiece while a structural layer of the mouthpiece maintains a structural shape of the mouthpiece; forming a customized dental interface by molding the moldable layer against dentition of a user; allowing the moldable layer to harden to retain the customized dental interface; and after the moldable layer has hardened, as taught by Meade, in order to provide an improved mouthpiece with enhanced upper and lower guards having a flexible and rigid layer for increased geometric conformance and support for a user’s upper and lower teeth, with the capability of being heated and softened to comfortably fit a user’s dental shape (Meade, Col. 9, lines 56-65).
Regarding claim 14, the combination of Hernandez in view of Meade discloses the invention as described above. Hernandez further discloses wherein actuating the adjustable assembly 20,24 22,26 (comprises rotating a threaded screw 54 56 (Paragraphs 19, 21 and Figure 1, The position of the pointer 60 relative to the parallel ridges on the side panel of block 24 indicates how much the first/left screw 54 is fastened into the threaded hole of block 24, which allows the user to know how much the lower arch 14 is moved forward with respect to the upper arch 12. Similar with second screw 56 on right side) to advance the lower guard 12 forward relative to the upper guard 14.
Regarding claim 16, the combination of Hernandez in view of Meade discloses the invention as described above. Hernandez further discloses wherein the adjustable assembly 20,24 22,26 comprises a first adjustable assembly 20,24 on a first side (Figure 3, left side) of the mouthpiece and a second adjustable assembly 22,26 on a second side (Figure 3, right side) of the mouthpiece.
a first adjustable assembly 20,24 (Paragraph 19 and Figure 1) comprising: a first guide 20 (Paragraphs 19-20 and Figure 1, block 20 connected to bottom surface of upper guard 12 on left side) fixed to the bottom surface of the upper guard 12 on the first side; a second guide 24 (Paragraph 19 and Figure 1, block 24 connected to bottom surface of the lower guard 14 on left side) fixed to the bottom surface of the lower guard on the third side; and a first screw 54 (Paragraph 19 and Figure 1, first screw 19) configured to engage(Paragraph 21 and Figure 1, first screw 54 is placed through the non-threaded hole of block 20 and then fastened into the threaded hole of block 24) the first guide 20 and the second guide 24 to adjust the respective positions (Paragraph 21 and Figure 1, The position of the pointer 60 relative to the parallel ridges on the side panel of block 24 indicates how much the first screw 54 is fastened into the threaded hole of block 24, which allows the user to know how much the lower arch 14 is moved forward with respect to the upper arch 12) of the upper guard 12 and the lower guard 14 when the mouthpiece 10 is in the closed position; and a second adjustable assembly 22,26 (Paragraph 22 and Figure 1) comprising: a third guide 22 (Paragraph 22 and Figure 1, block 22 fixed to bottom surface of upper guard 12 on right side) fixed to the bottom surface of the upper guard 12 on the second side; a fourth guide26 (Paragraph 22 and Figure 1, block 26 fixed to bottom surface of lower guard 14 on right side) fixed to the bottom surface of the lower guard 14 on the fourth side; and a second screw 56 (Paragraph 22 and Figure 1, second screw 56) configured to engage (Paragraph 21 and Figure 1, first screw 54 is placed through the non-threaded hole of block 20 and then fastened into the threaded hole of block 24) the first guide 20 and the second guide 24 to adjust the respective positions (Paragraph 21 and Figure 1, The position of the pointer 60 relative to the parallel ridges on the side panel of block 24 indicates how much the first screw 54 is fastened into the threaded hole of block 24, which allows the user to know how much the lower arch 14 is moved forward with respect to the upper arch 12) of the upper guard 12 and the lower guard 14 when the mouthpiece 10 is in a closed position (Paragraph 21, when upper guard 12 is placed over the lower guard 14).
Regarding claim 17, the combination of Hernandez in view of Meade discloses the invention as described above but fails to explicitly disclose wherein each of the first adjustable assembly and the second adjustable assembly comprises a guide positioned within a channel formed in the upper guard or the lower guard.
Meade further teaches an analogous mouthpiece 10 (Col. 7, lines 20-21, mouthpiece 10 is provided with upper 120 and lower platforms 130 which are positioned and protect a wearer’s teeth) wherein the analogous first adjustable assembly 156,158,160 (Col. 12, lines 1-5 and Figure 1, blocks 156 and 158 for receiving longitudinal screw 160 on a left side of the upper member 120 and lower member 130, for controlling the forward and backward movement of the upper member 120 with respect to the lower member 130) and the analogous second adjustable assembly 156,158,160 (Col. 12, lines 1-5 and Figure 1, blocks 156 and 158 for receiving longitudinal screw 160 on a right side of the upper member 120 and lower member 130, for controlling the forward and backward movement of the upper member 120 with respect to the lower member 130) comprises a guide 154,158 positioned within a channel (Col. 12, lines 1-5 and Figure 8: since the lower plate 154 and block 158 of the second guide is embedded in the lower member 130, the second guide is thereby positioned in a second channel in the bottom surface the lower member 130. Upper plate 152 is embedded in the resilient semi-rigid material or shell layer of the upper member 120. Upper plate 152 fixed to the bottom surface or shell layer of the upper member 120 on the left side of the upper member 120) formed in the upper guard 120 and the lower guard 130.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the bottom surfaces of the upper and lower guards of Hernandez in view of Meade, so that the first guide is positioned in a first channel in the bottom surface of the upper guard; the second guide is positioned in a second channel in the bottom surface of the lower guard; the third guide is positioned in a third channel in the bottom surface of the upper guard; and the fourth guide is positioned in a fourth channel in the bottom surface of the lower guard, as taught by Meade, in order to provide an improved mouthpiece with upper and lower guards having channels allowing for an embedded configuration between the guards and guides, ultimately providing a space and secure connection to facilitate mandibular advancement (Meade, Col. 12, lines 1-7). Regarding claim 20, the combination of Hernandez in view of Meade discloses the invention as described above. Hernandez further disclose wherein the upper guard 12 and the lower guard 14 are coupled by flexible connectors 16,18 Paragraph 26 and Figure 3)that allow the upper guard to fold over the lower guard.
12. Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (U.S. Patent Pub. No. 20110226261) in view of Meade (U.S. Patent No. 6055986), as applied to claim 1, and in further view of Webster et al. (U.S. Patent Pub. No. 20130098372).
Regarding claim 3, the combination of Hernandez in view of Meade discloses independent claim 1 as described above but fails to explicitly disclose a first spacer and a second spacer fixed to, and extending from, the bottom surface of the upper guard to define a central air passage.
Webster teaches an analogous mouthpiece 10 (Paragraph 46, mandibular advancement device 10 is positioned on wearer’s teeth) with a first spacer 20a (Paragraph 75, right post 20a) and a second spacer 20b (Paragraph 75, left post 20b) fixed to (Figure 1, posts 20a, 20b are fixed to bottom surface of upper tray 12), and extending from (Figure 1, posts 20a, 20b extend from the bottom surface of upper tray 12), an analogous bottom surface (Figure 1, mandibular advancement device 10 is in an open position showing the bottom surface of the upper maxillary tray 12 and lower mandibular tray 14) of an analogous upper guard 12 (Paragraph 73, upper maxillary tray 12) to define a central air passage (Paragraphs 26 and 38, These posts 20a, 20b create an air gap that prevents the upper tray and lower tray from completely closing against one another when the mandibular advancement device 10 is in a closed position as shown in Figure 7).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the bottom surface the upper guard of Hernandez in view of Meade, so that it includes the two spacers of Webster, in order to provide an improved mouthpiece that has a mechanical spacer element to prevent the mouthpiece from completely closing as well as the lower guard and upper guard from becoming co-planar (Webster, Paragraph 12).
Regarding claim 12, the combination of Hernandez in view of Meade in view of Webster discloses the invention as described above but fails to explicitly disclose a third spacer fixed to, and extending from, the third side; and a fourth spacer fixed to, and extending from, the fourth side.
Webster further teaches an analogous mouthpiece 10 (Paragraph 46) with a third spacer 21b (Paragraph 90, left retention post 21b) fixed to (Figure 1, post 21b is fixed to the left bottom surface of lower member 14), and extending from (Figure 1, post 21b extends from the left bottom surface of lower member 14), the analogous third side (Figure 1, left side of lower member 14); and a fourth spacer 21a (Paragraph 90, right retention post 21a) fixed to (Figure 1, post 21a is fixed to the right bottom surface of lower member 14), and extending from (Figure 1, post 21a extends from the right bottom surface of lower member 14), the analogous fourth side (Figure 1, right side of lower member 14).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the bottom surface the lower guard of Hernandez in view of Meade in view of Webster, so that there is also the third and fourth spacers, as taught by Webster, in order to provide an improved mouthpiece that has a mechanical spacer element to prevent the mouthpiece from completely closing as well as the lower guard and upper guard from becoming co-planar (Webster, Paragraph 12).
13. Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (U.S. Patent Pub. No. 20110226261) in view of Meade (U.S. Patent No. 6055986), as applied to claim 7 and 13, repectively, and in further view of Oxman et al. (U.S. Patent No. 5415544).
Regarding claim 8, the combination of Hernandez in view of Meade discloses the invention as described above and further discloses ( in Col. 9, line 41 of Meade) the first 128 (Meade, Col. 9, line 41, first shell layer of upper member 120 is defined by an upper platform floor 128) and second shell layers 138 (Meade, Col. 9, line 41, second shell layer of lower member 130 is defined by a lower platform floor 138).
However the combination of Hernandez in view of Meade does not disclose that the shell layers are polypropylene.
Oxman teaches (Abstract; Col. 8, lines 27-34) an analogous mouthpiece 5a (Abstract, a preloaded impression tray 5a provided to be positioned on a wearer’s teeth) wherein an analogous shell layer 1a (Abstract, shell 1a) is polypropylene (Col. 8, lines 27-34, A wide variety of rigid shell 1a materials can be used. Preferably the chosen material is free of objectionable taste or odor, and safe for use in the mouth. A suitable material include polypropylene).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the shell layers of Hernandez in view of Meade, so that they are polypropylene as taught by Oxman, in order to provide an improved mouthpiece with a safe and versatile polypropylene material for the shell layer that has the benefits of increased stiffness, durability, lightweight design, and is odorless or tasteless (Oxman, Col. 8, lines 27-34).
Regarding claim 15, the combination of Hernandez in view of Meade further discloses the first 142 (Meade, Col. 9, lines 56-65, the upper member 120 comprises a resin layer 142 forming a top surface, wherein the resin layer 142 is formed of a material which can be easily molded in the user's mouth) and second mold layer 144 (Meade Col. 9, lines 56-65, the lower member 130 comprises a resin layer 144 forming a top surface, wherein the resin layer 142 are formed of a material which can be easily molded in the user's mouth) are ethylene vinyl acetate (Col. 9, lines 56-65, resin layers 142 and 144 are formed from a flexible ethylene-vinyl acetate copolymer resin thermoplastic).
However the combination of Hernandez in view of Meade does not disclose that the shell layers are polypropylene.
Oxman teaches (Abstract; Col. 8, lines 27-34) an analogous mouthpiece 5a (Abstract, a preloaded impression tray 5a provided to be positioned on a wearer’s teeth) wherein an analogous shell layer 1a (Abstract, shell 1a) is polypropylene (Col. 8, lines 27-34, A wide variety of rigid shell 1a materials can be used. Preferably the chosen material is free of objectionable taste or odor, and safe for use in the mouth. A suitable material include polypropylene).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the shell layers of Hernandez in view of Meade, so that they are polypropylene as taught by Oxman, in order to provide an improved mouthpiece with a safe and versatile polypropylene material for the shell layer that has the benefits of increased stiffness, durability, lightweight design, and is odorless or tasteless (Oxman, Col. 8, lines 27-34).
14. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (U.S. Patent Pub. No. 20110226261) in view of Meade (U.S. Patent No. 6055986), as applied to claim 1, and in further view of Magnin (EP Patent No. 3167852).
Regarding claim 9, the combination of Hernandez in view of Meade discloses independent claim 1 as described above but fails to explicitly disclose a plurality of perforations extend through the first and second shell layers; and the first and second mold layers each include a plurality of anchors extending through the perforations to bind the mold layers of the upper and lower guards to the shell layers of the upper and lower guards, respectively.
Magnin teaches (Abstract; Paragraphs 16, 52, 67, 72; Figure 11) an analogous mouthpiece 100 (Paragraph 72, brace 100 positioned and protecting wearer’s teeth) comprising a plurality of perforations 5 (Paragraph 52, holes 5) that extend through (Paragraph 52, orifices 5 formed from side to side in the occlusal wall 23 of the shell frame 2) analogous first 2 (Abstract, shell frame 2 of rigid synthetic material; see Modified Figure 1 below, first shell layer 2 is on upper dental tray 101) and second shell layers 2 (Abstract, shell frame 2 of rigid synthetic material; see Modified Figure 1 below, second shell layer 2 is on lower dental tray 102); and analogous first 3 (Abstract, mold 3 of thermoformable material; see Modified Figure 1 below, first mold layer 3 is on upper dental tray 101) and second mold layers 3 (Abstract, mold 3 of thermoformable material; see Modified Figure 1 below, second mold layer 3 is on lower dental tray 102) each include a plurality of anchors (Paragraph 67, the back pressure produced by the occlusal plate 9 when the impression is taken advantageously promotes the formation of anchoring pins of the mold 3 into the holes 5 provided for this purpose in the frame shell 2 by plating the material of the thermoformable mold 3 flowing through these orifices 5 during the impression taking, favoring the distribution of the material in the holes, in particular in the sections of larger dimensions, which in turn prevents the removal of material in these orifices 5 during cooling of the mold 3 of thermoformable material) extending through (Paragraph 52, insertion of the thermoformable material of the shell 3 through the holes 5 from the inner surface of the occlusal wall 23 to the outer surface the same occlusal wall 23. In this way, the shell 3 is thermoformable effectively anchored on the occlusal wall 23 of the frame 2 by means of tenons anchoring of thermoformable material into the holes 5) the perforations 5 (Paragraph 52, holes 5) to bind (Paragraph 16, the upper and lower guards of the invention advantageously compensates for the risk of loosening of the thermoformable mold of the shell frame by the presence of anchoring of the mold means on the shell frame, anchoring means operating localized binding of thermoformable mold on the shell frame, at selected positions for minimally disrupt the positioning of the splint in the mouth and to minimize its bulk) analogous mold layers 8, 9 (see Modified Figure 1 below, fist 8 and second 9 mold layers) of analogous upper 101 (Paragraph 72, upper dental tray 101) and lower guards 102 (Paragraph 72, lower dental tray 102) to the analogous shell layers 6, 7 (see Modified Figure 1 below, first 6 and second shell layer 7) of the analogous upper 101 (Paragraph 72, upper dental tray 101) and lower guards 102 (Paragraph 72, lower dental tray 102), respectively.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the shell and mold layers of Hernandez in view of Meade, so that the shell layers have perforations and the mold layers have anchors as taught by Magnin, in order to provide an improved mouthpiece that prevents removal of the mold layers from the shell layers for increased functionality without the need for additional adhesive sheet layers and other costly methods of attaching the shell to the mold (Magnin, Paragraph 52).
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14. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (U.S. Patent Pub. No. 20110226261) in view of Meade (U.S. Patent No. 6055986), as applied to claim 16, and in further view of Carter (U.S. Patent No. 6099304).
Regarding claim 18, the combination of Hernandez in view of Meade discloses the invention as described above but fails to explicitly disclose adjusting only one of the first adjustable assembly or the second adjustable assembly to asymmetrically advance the lower guard relative to the upper guard.
Carter teaches an analogous left/first and right/second adjustable assemblies (Col. 7, lines 10-15, Col. 10, lines 1-30, Col. 1`2, lines 55-60, and Figures 1 and 5: tooth attachments 22, 102 on left and right side with screws 36 for incremental adjustment of mandible relative to maxillary) with adjusting only one of the analogous first adjustable assembly 36 or the analogous second adjustable assembly 36 to asymmetrically advance the analogous lower tooth attachment 102 relative to the analogous upper tooth attachment 22 .
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify an adjustment of the first and second adjustable assembles of the upper and lower guards of Hernandez in view of Meade, so as to adjust only one of the first adjustable assembly or the second adjustable assembly to asymmetrically advance the lower relative to the upper, as taught by Carter, in order to provide an improved mouthpiece with an enhanced adjustment of the left and right sided adjustable assemblies for asymmetrical movement of a user’s mandible relative to their maxillary in cases where a patient is more Class II on one side of the mouth than on the other (Carter, Col. 7, lines 10-15).
14. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hernandez (U.S. Patent Pub. No. 20110226261) in view of Meade (U.S. Patent No. 6055986), as applied to claim 16, and in further view of Fallon et al. (U.S. Patent Pub. No. 20120145166).
Regarding claim 19, the combination of Hernandez in view of Meade discloses the invention as described above and further discloses submerging the mouthpiece in hot water (Col. 7, line 40 and 67) to soften the moldable layer.
However, the combination of Hernandez in view of Meade fails to explicitly disclose boiling water.
Fallon teaches an analogous mouthpiece 1 (Paragraph 45 and Figure 2) in boiling analogous water (Paragraph 45, placing mandibular advancement appliance 1 in boiling water).
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a temperature of the water of Hernandez in view of Meade, so that the water is boiling, as taught by Fallon, in order to provide an improved mouthpiece with an enhanced molding ensuring that the moldable layer heats up enough to allow the material to melt (Fallon, Paragraph 45).
Conclusion
15. 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.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Milo whose telephone number is (571)272-6476. The examiner can normally be reached on Mon-Fri 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached on +1(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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/MICHAEL MILO/
Art Unit 3786
/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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