DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments made to claims 1, 3, 5, and 8 in the response filed 10/13/25 are acknowledged.
Claims 1-8 are still pending in the application and are examined below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. (Applicant’s arguments on p. 10-11 regarding Farrell failing to disclose the newly added limitations describing the first and second plurality of holes are moot in view of new reference Croll provided to teach these limitations).
Claim Objections
Claim 1 is objected to because of the following informalities: “poster” in line 8 should be amended to recite --posterior--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 8, the claim recites the limitation “resin callout” in line 3. Based on a general internet web search as well as a text search of mouthguard and dental classifications, “resin callout” does not appear to be a term used in the art. Further, the specification does not provide any definition or elaboration on the term. The closest search result is a resin identification code, which has not directly been referred to as a resin callout. However, ASTM callouts refer to ASTM technical standard/codes, so resin callouts may be referred to by Applicant to mean the resin identification code. Even if this is the case, this language does not make sense in the claim language, where the base and ridge are composed of a resin callout. Therefore, it is unclear what the Applicant is trying to claim as the material of the base and resin. For purposes of compact prosecution and examination, the base and ridge are interpreted to be composed of resin.
Claim 8 further recites “the exterior surface” in line 11, “the anterior section” in line 12, and “the interior surface” in line 13. There is insufficient antecedent bases for these limitations in the claim.
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, 2, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell US 2014/0352704 A1 in view of Croll et al. US 5,692,523.
Regarding claim 1, Farrell discloses a protective oral appliance 80 (fig. 14 and [0108], double mouthguard 80) comprising:
a first U-shaped channel 24 adapted to engage a user’s upper teeth when worn (fig. 14 and [0080], upper arch receiving channel 24; please also note in [0108], it is stated that the embodiment of figs. 14-24 use the same reference numerals previously used for the single mouthguard 10 of the previous embodiment) and having a first inner facing wall 20 (fig. 21 and [0080], inner wall 20), a first outer facing wall 18 (fig. 14 and [0080], outer wall 18), and a first bottom 22 connecting the first inner facing wall 20 and the first outer facing wall 18 (fig. 21 and [0080], web 22);
a second U-shaped channel adapted to simultaneously engage the user’s lower teeth when worn and having a second inner facing wall, a second outer facing wall, and a second bottom connecting the second inner facing wall and the second outer facing wall (fig. 19 and [0109], where the double mouthguard 80 extends downwards to cover the lower teeth; please see annotated fig. A below, which shows the second inner and outer walls, and the second bottom which forms the second U-shaped channel); and
a plurality of holes 30 (fig. 14 shows holes 30; these holes 30 are also shown in fig. 1 and described in [0083] as breathing holes);
wherein the plurality of holes 30 are adapted to allow air to pass through the oral appliance 80 and into the user’s mouth ([0083], breathing holes 30).
Farrell is silent on the plurality of holes being a first plurality of holes continuously distributed across an anterior region and a posterior region of the first U-shaped channel and a second plurality of holes situated across an anterior region and a posterior region of the second U-shaped channel.
However, Croll teaches an analogous protective oral appliance (fig. 1 and col. 1, lines 4-7) comprising an analogous plurality of holes 13 (fig. 1 and col. 3, lines 15-16, breathing ducts) that are a first plurality of holes 13 continuously distributed across an anterior region and a posterior region of the analogous first U-shaped channel and a second plurality of holes 13 situated across an anterior region and a posterior region of the analogous second U-shaped channel (please see figs. 1, 2, and 4, which shows the upper holes 13 being continuously distributed across the anterior/forward part of the outer wall of the upper U-shaped channel, as well as the posterior/rear legs; the lower holes 13 are similarly situated across the lower U-shaped channel; as figs. 1, 2, and 4 do not individually show all the holes due to their perspectives, fig. 5 further shows the holes being continuously distributed across the length of the upper and lower outer walls, such that the holes would extend across the anterior/forward part and posterior/rear legs of each outer wall of the upper and lower channels when the device makes the U-shape).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the plurality of holes of Farrell to be a first plurality of holes continuously distributed across an anterior region and a posterior region of the first U-shaped channel and a second plurality of holes situated across an anterior region and a posterior region of the second U-shaped channel, as taught by Croll, to allow even distribution of air into the mouth across the entire oral appliance, enabling better breathing.
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Regarding claim 2, Farrell in view of Croll discloses the claimed invention as discussed above.
Farrell further discloses the first U-shaped channel 24 being coupled to the second U-shaped channel (fig. 19, the upper and lower channels being coupled to each other as they are part of a singular device).
Regarding claim 6, Farrell in view of Croll discloses the claimed invention as discussed above.
Farrell further discloses a bite tab 40 configured to engage at least one tooth of the user’s upper teeth and at least one tooth of the user’s lower teeth when worn (fig. 16 and 24, and [0019], [0088]-[0089], frame member 40 is encased within the body of the mouthguard between the upper and lower channel, and it provides rigidity to the mouthguard; since it is located between the upper and lower teeth when worn, the frame 40 would indirectly engage the upper and lower teeth, since the force applied by the upper and lower teeth would be transmitted through the frame 40; please note that Applicant’s bite tab also does not directly engage the teeth).
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell US 2014/0352704 A1 in view of Croll et al. US 5,692,523 further in view of Manzo US 2011/0005531 A1.
Regarding claims 3 and 4, Farrell in view of Croll discloses the claimed invention as discussed above.
Farrell in view of Croll is silent on an open airway defined by an anterior section between the first U-shaped channel and the second U-shaped channel, wherein the open airway includes at least one support column extending from an upper side of the open airway to a lower side of the open airway.
However, Manzo teaches an analogous protective oral appliance 10 (fig. 1 and [0029], shock absorbing dental appliance) comprising an open airway 46 defined by an anterior section between the first U-shaped channel 30 and the second U-shaped channel 32 (fig. 4 and [0030], upper channel 30 and lower channel 32; [0035], airway opening 46; fig. 1 shows airway opening 46 positioned at the anterior tip of the appliance 10 such that it defines an anterior section), wherein the open airway 46 includes at least one support column 48 extending from an upper side of the open airway 46 to a lower side of the open airway 46 (fig. 4 and [0035], airway opening 46 has post 48 for providing structural support to resist collapse of the airway opening 46 during use).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral appliance of Farrell in view of Croll with an open airway defined by an anterior section between the first U-shaped channel and the second U-shaped channel, wherein the open airway includes at least one support column extending from an upper side of the open airway to a lower side of the open airway, as taught by Manzo, to allow for greater breathing capacity while wearing the mouthguard, as the small holes 30 of Farrell may get blocked by saliva during use.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell US 2014/0352704 A1 in view of Croll et al. US 5,692,523 further in view of Turkbas US 2019/0282886 A1.
Regarding claim 5, Farrell in view of Croll discloses the claimed invention as discussed above.
Farrell in view of Croll is silent on each hole being 1mm - 2mm wide.
However, Turkbas teaches an oral appliance 100 (fig. 1 and [0042], mouthguard 100) comprising analogous holes 112 being 1mm - 2mm wide (fig. 1 and [0047], holes 112 may have a diameter of about 2, 1.5, or 1 mm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified each hole of Farrell in view of Croll to be 1mm - 2mm wide, as taught by Turkbas, to provide adequate flow of air without being too large so as to permit debris to flow through.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farrell US 2014/0352704 A1 in view of Croll et al. US 5,692,523 further in view of Fenton US 5,499,633.
Regarding claim 7, Farrell in view of Croll discloses the claimed invention as discussed above.
Farrell further discloses the first U-shaped channel 24 being formed using at least one of polyethylene-polyvinyl acetate copolymer (EVA) (fig. 15 and [0085], the inner wall member 32 is formed from EVA; thus, since the inner wall member 32 forms the upper U-shaped channel, the upper U-shaped channel is formed from EVA), silicone, carbon fiber, and nanofiber.
Farrell in view of Croll is silent on the second U-shaped channel being formed using at least one of polyethylene-polyvinyl acetate copolymer (EVA), silicone, carbon fiber, and nanofiber.
However, Fenton teaches an oral appliance 10 (fig. 1 and col. 1, lines 13-16) comprising analogous first and second U-shaped channels 20/21 (fig. 3), both being formed using at least one of polyethylene-polyvinyl acetate copolymer (EVA) (fig. 3 and col. 5, lines 6-13, upper channel 20 and lower channel 21; col. 5, lines 30-36, channels 20/21 may be filled with moldable material 24, which may be ethylene-vinyl acetate (EVA) copolymer resin).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the second U-shaped channel of Farrell in view of Croll to also be formed using at least one of polyethylene-polyvinyl acetate copolymer (EVA), silicone, carbon fiber, and nanofiber, as taught by Fenton, to provide a comfortable, moldable surface for the lower teeth in addition to the upper teeth.
Regarding claim 8, Farrell discloses an oral device 10 for protecting a user from injuries (fig. 1 and [0079], mouthguard 10), comprising:
a U-shaped base 10 having a U-shaped cross-section comprising a lower, horizontal floor 22 with upwardly extending inner lingual 20 and outer labial 18 walls (fig. 1 and [0080], outer wall 18, inner wall 20, connected by web 22), and posterior sections 14/16 configured to extend proximate to the user’s molar (fig. 1 and [0079], arms 14/16),
wherein the U-shaped base 10 includes a plurality of holes 30 for increase uptake of oxygen while wearing the oral device 10 (fig. 1 and [0083], breathing holes 30); and
a continuous ridge 68 integral with the U-shaped base 10 (figs. 5 and 6 and [0098], braces channel 68 extends along the length of the inside of the device, coextensive with and integral with the base material of the U-shaped base 10),
wherein the ridge 68 comprises an outer horizontal portion disposed on the exterior surface of the outer labial wall 18 of the anterior section 12 (please see annotated fig. B below, where the indicated outer horizontal portion is the upper portion of the braces channel 68 on the outer wall 18 that extends generally horizontally along the width of the anterior section 12 of the mouthguard; further, since this horizontal portion forms the inner surface of the outer wall 18, it can be interpreted to be “disposed on” the exterior surface of the outer wall 18, since they form opposing surfaces of the same wall 18) and terminating in opposite inner horizontal portions disposed on the interior surface of the horizontal floor 22 of the posterior section 14/16 (annotated fig. B, where the indicated inner horizontal portions form horizontal ledges that protrude into the channel and are disposed on top of the interior surface of the floor 22 in the arms 14/16).
Farrell is silent on the plurality of holes being continuously distributed across an anterior region and posterior regions of the U-shaped base.
However, Croll teaches an analogous protective oral appliance (fig. 1 and col. 1, lines 4-7) comprising an analogous plurality of holes 13 (fig. 1 and col. 3, lines 15-16, breathing ducts) that are continuously distributed across an anterior region and posterior regions of the analogous U-shaped base (please see figs. 1, 2, and 4, which shows the upper holes 13 being continuously distributed across the anterior/forward part of the outer wall of the upper U-shaped base, as well as the posterior/rear legs; as figs. 1, 2, and 4 do not individually show all the holes due to their perspectives, fig. 5 further shows the holes being continuously distributed across the length of the upper and lower outer walls, such that the holes would extend across the anterior/forward part and posterior/rear legs of each outer wall of the upper and lower channels when the device makes the U-shape).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the plurality of holes of Farrell to be continuously distributed across an anterior region and posterior regions of the U-shaped base, as taught by Croll, to allow even distribution of air into the mouth across the entire oral appliance, enabling better breathing.
Farrell in view of Croll is silent on the U-shaped base and ridge being formed of resin.
However, Fenton teaches an oral appliance 10 (fig. 1 and col. 1, lines 13-16) comprising an analogous U-shaped base 12/16 (fig. 3 and col. 5, lines 6-13) being formed of resin (col. 5, lines 13-25, polycarbonate resin).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the U-shaped base (and thus the ridge, which is part of the U-shaped base) of Farrell in view of Croll to be formed of resin, as taught by Fenton, to provide a suitable framework for the device (col. 5, lines 21-25).
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ALIREZA NIA can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786