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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 July 2025 has been entered.
Claim Rejections - 35 USC § 103
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Friedhelm (DE 2656693 A1 and translated PDF) in view of Williams (U.S. Publication No. 2008/0003535 A1) in view of Pourcho (U.S. Patent No. 5,158,451 A) in view of Mitani (U.S. Publication No. 2009/0098499 A1).
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In regard to claim 1, Friedhelm discloses a mouthpiece (Figs. 1 and 5-6) capable of being mounted in an oral cavity of a user (Fig. 1, paras. 0002 and 0016), the mouthpiece comprising: a plurality of segment pieces (2 and 3 Fig. 1) capable of pressing a tooth (paras. 0011 and 0018); and a plurality of screws (plurality of screws in annotated Fig. 1) connecting at least two of the plurality of segment pieces (Fig. 1), respectively, and capable of adjusting a distance between the connected at least two of the plurality of segment pieces (Fig. 1, para. 0018).
Friedhelm does not disclose wherein the at least two of the plurality of segment pieces are disposed to overlap each other, such that portions of the at least two of the plurality of segment pieces form a closed surface configured to face or contact with a skin of the user, and maintains the closed surface even when the distance between the connected at least two of the plurality of segment pieces is adjusted, the mouthpiece further comprising a head gear configured to be mounted outside the oral cavity, wherein the head gear is configured such that a reaction force vector to an action force vector caused by the plurality of screws is canceled by a support force caused by the head gear, wherein the head gear includes a connecting wire having a latch, wherein each of the plurality of segment pieces includes a holder disposed on a bottom surface thereof and having a blind hole or a through-hole, wherein the latch includes a protrusion couplable to and detachable from the blind hole or the through-hole of the holder, and wherein one or more of the plurality of segment pieces are connected to the head gear, through the connecting wire, by coupling the protrusion with the blind hole or the through-hole of the holder.
Williams teaches an apparatus (Figs. 1-3) comprising a screw (12 in Fig. 1) connecting at least two of a plurality of segment pieces (6 and 7 in Figs. 1-3, para. 0025-0026), wherein the at least two of the plurality of segment pieces are disposed to overlap each other (Figs. 1-3), such that portions of the at least two of the plurality of segment pieces form a closed surface capable of facing a skin of the user (Figs. 1-3), and maintains the closed surface even when the distance between the connected at least two of the plurality of segment pieces is adjusted (Figs. 1-3, para. 0028).
Pourcho teaches an apparatus (Figs. 1-6) comprising a device (col. 4 lines 3-5, braces) further comprising a head gear (12 in Fig. 1) capable of being mounted outside the oral cavity (Fig. 1), wherein the head gear is configured such that a reaction force vector to an action force vector is canceled by a support force caused by the head gear (Abstract, col. 2 lines 44-51).
Mitani teaches a mouthpiece (Figs. 1-6) comprising a plurality of segment pieces (43 and 44 in Fig. 3) further comprising a head gear (12 in Fig. 1) capable of being mounted outside the oral cavity (Fig. 1), wherein the head gear includes a connecting wire (57 and 61 in Fig. 3) having a latch (latch in annotated Fig. 3, hooked end portion of wire), wherein each of the plurality of segment pieces includes a holder (53 and 54 in Fig. 3, paras. 0106) disposed on a bottom surface thereof (Fig. 3) and having a through-hole (para. 0106, holder is a tube), wherein the latch includes a protrusion (62a and 58a in Fig. 3) couplable to and detachable from the through-hole of the holder (Fig. 3, para. 0113), and wherein one or more of the plurality of segment pieces are connected to the head gear, through the connecting wire, by coupling the protrusion with the through-hole of the holder (Fig. 3, para. 0113).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of orthodontic devices.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least two of the plurality of segment pieces of Friedhelm by modifying the shape of the segments so that the at least two of the plurality of segment pieces are disposed to overlap each other, such that portions of the at least two of the plurality of segment pieces form a closed surface capable of facing a skin of the user, and maintains the closed surface even when the distance between the connected at least two of the plurality of segment pieces is adjusted as taught by Williams in order to allow for imparting of lateral forces outwards (Williams para. 0027) to result in a desired arcuate form (Williams para. 0024).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mouthpiece of Friedhelm in view of Williams by adding a head gear capable of being mounted outside the oral cavity, wherein the head gear is configured such that a reaction force vector to an action force vector is canceled by a support force caused by the head gear as taught by Pourcho in order to allow for application of desired forces on the patient’s jaws (Pourcho col. 4 lines 6-38).
The combination of Friedhelm in view of Williams in view of Pourcho teaches wherein the head gear is configured such that a reaction force vector to an action force vector caused by the plurality of screws (Friedhelm, plurality of screws in annotated Fig. 1) is canceled by a support force caused by the head gear (Abstract, col. 2 lines 44-51).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the headgear of Friedhelm in view of Williams in view of Pourcho by adding a connecting wire having a latch, wherein each of the plurality of segment pieces includes a holder disposed on a bottom surface thereof and having a blind hole or a through-hole, wherein the latch includes a protrusion couplable to and detachable from the blind hole or the through-hole of the holder, and wherein one or more of the plurality of segment pieces are connected to the head gear, through the connecting wire, by coupling the protrusion with the blind hole or the through-hole of the holder as taught by Mitani in order to allow for enabling teeth movement to a considerable extent (Mitani para. 0164), and securing higher safety and cost efficiency of treatment (Mitani para. 0165).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Friedhelm in view of Williams in view of Pourcho in view of Mitani in view of Davidovitch et al (U.S. Publication No. 2015/0343208 A1, hereinafter “Davidovitch”).
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In regard to claims 13 and 14, Friedhelm in view of Williams and Mitani discloses the invention of claim 1. Friedhelm does not disclose wherein at least one of the plurality of segment pieces includes a generator configured to convert a masticatory force of the user into electrical energy or a power storage configured to store electrical energy,
wherein the mouthpiece is configured to drive, using the electrical energy, at least one of a low frequency generator, an infrared light emitting diode (LED), an ultraviolet LED, a screw drive motor, a wireless communication module with an external terminal, and a screw actuation sensor.
Davidovitch teaches an apparatus (Figs. 2A-2D and Fig. 5, para. 0073) for use in the oral cavity (Abstract) comprising a plurality of segment pieces (segment 1 and 2 in annotated Fig. 5) wherein at least one of the plurality of segment pieces includes a power storage (30 in Fig. 5) capable of storing electrical energy (para. 0045),
wherein the mouthpiece is capable of driving, using the electrical energy, an infrared LED (430 in Fig. 5).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of orthodontic devices. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mouthpiece of Friedhelm in view of Williams and Mitani by adding a power storage to at least one of the plurality of segment pieces, the power storage being capable of storing electrical energy to drive an infrared LED to emit infrared light as taught by Davidovitch in order to increase blood circulation and enhance osteogenesis (Davidovitch para. 0074).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Friedhelm in view of Williams in view of Pourcho in view of Mitani in view of Bollen et al (Comparison of surface roughness of oral hard materials…, see attached PDF, hereinafter “Bollen”).
In regard to claim 15, Friedhelm in view of Williams and Mitani discloses the invention of claim 1. Friedhelm does not disclose wherein the mouthpiece is comprised of a material having surface roughness (Ra) of 0.2 to 0.4 μm.
Bollen teaches that the roughness of materials used in the mouth should have an Ra of 0.2 μm to reduce retention of oral microorganisms (Bollen p. 261, right column para. 3).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of oral devices. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mouthpiece of Friedhelm in view of Williams and Mitani by fabricating it of a material having an Ra of 0.2 μm as taught by Bollen in order to slow colonization of the surface with bacteria (Bollen p. 264, right column para. 3)
Response to Arguments
Applicant’s arguments filed 28 July 2025 have been fully considered but they are not persuasive.
In regard to Applicant’s arguments regarding Kuklinski, Examiner notes that in the above rejection, Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Friedhelm in view of Williams in view of Pourcho in view of Mitani, Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Friedhelm in view of Williams in view of Pourcho in view of Mitani in view of Davidovitch, and Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Friedhelm in view of Williams in view of Pourcho in view of Mitani in view of Bollen. Applicant is directed to the rejections in view of the amendments.
In regard to Applicant’s arguments regarding Mitani and the limitation of amended claim 1, “the head gear is configured such that a reaction force vector to an action force vector caused by the plurality of screws is cancelled by a support force caused by the head gear”, Examiner notes that in the above rejection, Pourcho teaches an apparatus (Figs. 1-6) comprising a mouthpiece (col. 4 lines 3-5) further comprising a head gear capable of being mounted outside the oral cavity (Fig. 1), wherein the head gear is configured such that a reaction force vector to an action force vector is canceled by a support force caused by the head gear (Abstract, col. 2 lines 44-51). One of ordinary skill in the art would have been motivated to have modified Friedhelm in view of Williams by the teachings of Pourcho in order to allow for application of desired forces on the patient’s jaws (Pourcho col. 4 lines 6-38). The combination of Friedhelm in view of Williams in view of Pourcho teaches wherein the head gear is configured such that a reaction force vector to an action force vector caused by the plurality of screws (Friedhelm, plurality of screws in annotated Fig. 1) is canceled by a support force caused by the head gear (Abstract, col. 2 lines 44-51).
In regard to Applicant’s arguments that Mitani does not disclose a holder disposed on a bottom surface thereof and having a blind hole or a through-hole, Examiner notes Applicant’s arguments are narrower than the claims as the claims do not exclude embedding of the holder. Though the holders 53 and 54 are embedded in the floor parts 43, 44, the holder, and especially the opening of the holders, are also disposed on the bottom surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY N HUYNH whose telephone number is (571)272-7219. The examiner can normally be reached M-F 7:30AM-5:00PM (EST) flex, 2nd Friday off.
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/COURTNEY N HUYNH/Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772