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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/17/26 has been entered.
Response to Amendment
The amendments made to claims 1 and 8 in the response filed 4/17/26 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 (new reference Maloney has been provided to teach the newly added limitations regarding the matching features and impressions/scans).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the first U-shaped channel having a first perimeter matching a first corresponding perimeter on impressions or scans of the user’s upper teeth the second U-shaped channel having a second perimeter matching a second corresponding perimeter on impressions or scans of the user’s lower teeth was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While the specification generally states that the device is designed based on the acquired impression or input scan, it does not provide enough detail to conclude that the upper and lower channels specifically have first and second perimeters that match corresponding perimeters on impressions or scans. Designing one thing based upon another does not inherently mean that they exactly match, and the claimed perimeters were not described as matching a corresponding perimeter on impressions or scans.
Regarding claim 8, the lower horizontal floor with upwardly extending inner lingual and outer labial walls matching a corresponding lower horizontal floor with upwardly extending inner lingual and outer labial walls on impressions or scans of the user’s upper or lower teeth was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While the specification generally states that the device is designed based on the acquired impression or input scan, it does not provide enough detail to conclude that the U-shaped cross section specifically has a horizontal floor and walls that match corresponding features on impressions or scans. Designing one thing based upon another does not inherently mean that they exactly match, and the claimed floor/walls were not described as matching corresponding floor/walls on impressions or scans.
Regarding claims 2-7, the claims are rejected under 35 U.S.C. 112(a) by virtue of their dependence on claim 1.
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 “the user’s molar” in line 5. It is unclear which of the user’s molars is being referred to by this limitation, making the scope of the claim unclear.
Further, the claim recites “the exterior surface” in line 14, “the anterior section” in line 15, “the interior surface” in line 16, and “the posterior section” in line 16. There is insufficient antecedent basis 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 further in view of Maloney et al. US 2020/0147473 A1.
Regarding claim 1, Farrell discloses a protective oral appliance 80 (fig. 14 and [0108], double mouthguard 80) comprising:
a first U-shaped channel 24 (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) including 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 adapted to snugly engage each of the user’s upper teeth (fig. 21 and [0080], web 22, which is capable of fitting snugly with each of the upper teeth depending on the user’s specific oral structure);
a second U-shaped channel including 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 adapted to snugly engage each of the user’s lower teeth (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, which is capable of fitting snugly with each of the lower teeth depending on the user’s specific oral structure); 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.
Farrell in view of Croll is silent on the first U-shaped channel having a first perimeter adapted to register with each of a user’s upper teeth, the first perimeter matching a first corresponding perimeter on impressions or scans of the user’s upper teeth, the second U-shaped channel having a second perimeter adapted to register with each of a user’s lower teeth, the second perimeter matching a second corresponding perimeter on impressions or scans of the user’s lower teeth.
However, Maloney teaches a mouthguard 200 (fig. 1 and [0042]) with an analogous U-shaped channel 110/112/114 (fig. 4 and [0043], bite platform 110, labial flange 112, and lingual flange 114 form a U-shaped channel) having a perimeter adapted to register with each of a user’s teeth, the perimeter matching a corresponding perimeter on impressions or scans of the user’s teeth ([0081], based on a 3D scan of the subject’s mouth and teeth, a high-resolution full-scale representation of the teeth is printed; [0083], the mouthguard is formed by inserting the dentition geometry/representation within the mold; thus, the inner perimeter of the channel would be adapted to register with the user’s teeth and it would match the inner perimeter of the teeth of the 3D scan, since the channel is molded based on the full-scale representation formed from the 3D scan).
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 first and second U-shaped channels of Farrell in view of Croll such that the first U-shaped channel has a first perimeter adapted to register with each of a user’s upper teeth, the first perimeter matching a first corresponding perimeter on impressions or scans of the user’s upper teeth, the second U-shaped channel having a second perimeter adapted to register with each of a user’s lower teeth, the second perimeter matching a second corresponding perimeter on impressions or scans of the user’s lower teeth, as taught by Maloney, to most accurately conform the mouthguard to the teeth, providing better comfort and protection; please note that while Maloney does not specifically teach the perimeter and scans for the upper and lower teeth, Farrell already discloses both channels and their relationship relative to the upper and lower teeth; Maloney is provided solely to teach the relationship between the respective channels with their teeth and the impressions/scans of the teeth.
PNG
media_image1.png
533
791
media_image1.png
Greyscale
Regarding claim 2, Farrell in view of Croll further in view of Maloney 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 further in view of Maloney 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 Maloney et al. US 2020/0147473 A1 and Manzo US 2011/0005531 A1.
Regarding claims 3 and 4, Farrell in view of Croll further in view of Maloney discloses the claimed invention as discussed above.
Farrell in view of Croll further in view of Maloney 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 further in view of Maloney 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 Maloney et al. US 2020/0147473 A1 and Turkbas US 2019/0282886 A1.
Regarding claim 5, Farrell in view of Croll further in view of Maloney discloses the claimed invention as discussed above.
Farrell in view of Croll further in view of Maloney 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 further in view of Maloney 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 Maloney et al. US 2020/0147473 A1 and Fenton US 5,499,633.
Regarding claim 7, Farrell in view of Croll further in view of Maloney 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 further in view of Maloney 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 further in view of Maloney 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) configured to extend proximate to the user’s molar (fig. 1 and [0079], arms 14/16),
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 continuous 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).
Farrell in view of Croll further in view of Fenton is silent on the U-shaped cross section being adapted to register with each of a user’s upper or lower teeth, the lower horizontal floor with upwardly extending inner lingual and outer labial walls matching a corresponding lower horizontal floor with upwardly extending inner lingual and outer labial walls on impressions or scans of the user’s upper or lower teeth.
However, Maloney teaches a mouthguard 200 (fig. 1 and [0042]) with an analogous U-shaped cross section 110/112/114 (fig. 4 and [0043], bite platform 110, labial flange 112, and lingual flange 114 form a U-shaped cross section) adapted to register with each of a user’s upper or lower teeth, the lower horizontal floor 110 with upwardly extending inner lingual 114 and outer labial walls 112 matching a corresponding lower horizontal floor with upwardly extending inner lingual and outer labial walls on impressions or scans of the user’s upper or lower teeth ([0081], based on a 3D scan a negative impression of the mouth and teeth, a high-resolution full-scale representation of the teeth is printed; [0083], the mouthguard is formed by inserting the dentition geometry/representation within the mold; thus, the U-shaped cross section of the final mouthguard would be adapted to register with the user’s upper teeth, and it would also match the U-shaped cross section formed by the horizontal floor and lingual/labial walls of the 3D scan of the initial negative impression, since the channel is molded based on the full-scale representation formed from the 3D scan of the negative impression).
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 cross section of Farrell in view of Croll further in view of Fenton to be adapted to register with each of a user’s upper or lower teeth, the lower horizontal floor with upwardly extending inner lingual and outer labial walls matching a corresponding lower horizontal floor with upwardly extending inner lingual and outer labial walls on impressions or scans of the user’s upper or lower teeth, as taught by Maloney, to most accurately conform the mouthguard to the teeth, providing better comfort and protection.
PNG
media_image2.png
514
1064
media_image2.png
Greyscale
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHELLE J LEE/Primary Examiner, Art Unit 3786
Prosecution Insights