DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/09/2025 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al (US 2016/0081769) in view of Bengtsson et al (WO 2006/004541) and Truax et al (US 5,242,304)
In regard to claim 1, Kimura discloses a dental device (appliance 100, par 42 discloses the one or more appliances can be a retainer or positioner) comprising:
a unitary body (removable shell 102, see figures 1A-B) including:
an anterior teeth region (see annotated figure 1B) configured to hold a patient's anterior teeth within an anterior teeth pocket having lingual and occlusal sides (par 67 and figures 1A-B);
a first posterior teeth region and a second posterior teeth region (see annotated figure 1B) each configured to hold the patient's molars in a posterior teeth pocket having lingual and occlusal sides (par 67 discloses the positioning of the shell over the teeth of the patient); and
a palatal region (arch element 103/104) configured to extend between the first and second posterior teeth regions and adjacent to the patient's palate (see figure 1A-B and par 68-69 discloses the arch element 103/104 extending between the posterior sides of the appliance), wherein the palatal region is thicker than the occlusal side of the first and second posterior teeth regions (pars 135-136 discloses the arch element being formed of a second layer and that the second layer can he a thicker later of material than the first layer which is the material of the shell 102, therefore the palatal region is thicker than the layer on the posterior occlusal surfaces) and the palatal region having a first surface with a non-smooth surface (par 68 discloses the surface being corrugated) ;
and the palatal region starts at a transition curve that is configured to link multiple patient’s molars (see paragraph 76-77 discloses the application of movement force from the arch element onto the interior posterior molars in concurrent teeth, thus creating a transition curve between the ridge points of the crown surfaces).
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Annotated figure 1B
Kimura fails disclose a first surface of the palatal region is smoother than the second surface of the palatal region, further wherein the second surface is configured to be worn adjacent to the patient's palate and wherein a thickness of the palatal region gradually increases starting at the transition curve, wherein the transition curve is configured to link the multiple ridge points of crown surfaces of the patient’s molars and wherein the gradual increase in thickness ends at a middle portion of the palatal region.
Bengtsson teaches a palatal device (base plate 2) with a first surface (convex surface 8) which is smoother than a second surface (inner surface 16) of the palatal device (see figures 6-8, where the inner surface 16 has a stimulating member 9 which provides a texture not found on the convex surface 8), and the second surface is configured to be worn adjacent to the patient’s palate (see page 7, line 15-20 discloses the cones are positioned in a central position of the palatal plate and used or positioned adjacent to the tongue of the patient) for the purpose of providing stimulation (page 7, line 17).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura to have a first surface of the palatal region is smoother than a second surface of the palatal region, further wherein the second surface is configured to be worn adjacent to the patient's palate as taught by Bengtsson for the purpose of providing oral/lingual stimulation.
Truax teaches a palatal region (appliance 38) has a thickness of the palatal region that gradually increases starting at the transition curve (see figure 10, where the palatal region thickness gradually increases from the undercut 12 that is located at the ridge point of the crown and is the starting point of the palatal region being at the undercut 12), wherein the gradual increase in thickness ends at a middle portion of the palatal region (see figure 10) for the purpose of providing securely, offers greater stability and more efficient tooth and supporting alveolar bone movement due to the appliance (col 5, lines 6-10).
Therefore, it would be obvious to one of ordinary skill in the art at the time of invention to modify Kimura/Bengtsson to modify the transition curve to be located at the ridge point of the crown of the patient’s molars and have a thickness of the palatal region gradually increases starting at the transition curve located at the ridge point of the crown of the patient’s molar, wherein the gradual increase in thickness ends at a middle portion of the palatal region as taught by Truax for the purpose of providing securely, offers greater stability and more efficient tooth and supporting alveolar bone movement due to the appliance.
Regarding claim 3, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1. Truax teaches the thickness of the palatal region increases between the first and second posterior teeth regions (figure 10), for the reasons set forth above.
Regarding claim 4, Kimura further discloses the palatal region (104) comprises a plurality of strips (ridge and valley structure 105) extending between the first and second posterior regions (see figure 1B).
Regarding claim 5, Kimura further discloses the first and second posterior teeth regions each comprises a buccal surface configured to conform the patient's molars (see figure 1A-B).
Regarding claim 20, applicant is advised that statement “the top surface of the palatal region has a smooth spline surface” is considered a product by process claim and reminded that product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP 2113. In the instant case, Kimora discloses a top surface of the palatal region being shaped in accordance to the shape of a surface of the patient’s palate (par 63 discloses the use of virtual modeling to shape the arch element first portion to be shaped to the contours of the palate/floor of the mouth of the patient), which reads on the structure of the claim.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Bengtsson et al and Truax as applied to claim 1 above, and further in view of Sambu et al (US 2005/0275129).
Regarding claim 2, Kimura/Bengtsson/ Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose an identifying code on one or more of: the second surface of the palatal region or a posterior edge of the palatal region.
Sambu teaches including an identification code (readable identifier 720) on a surface of a palatal region (see figure 3B and par 27) for the purpose of facilitating subsequent manufacturing operations (par 27).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kimura/Bengtsson/ Truax to have an identification code placed on the palatal region as taught by Sambu for the purpose of facilitating subsequent manufacturing operations. Sambu fails to specifically disclose the positioning of the identification code on a bottom surface or posterior edge of the palatal region.
However, positioning the identification code on a bottom surface or posterior edge of the palatal region is considered an obvious matter of design choice lacking in criticality, well within the skill of an ordinary artisan, for the purpose of providing the information of the identification code to a manufacturer or user. Furthermore, absent a teaching as to criticality that having the angles be different provides an advantage, solves any stated problem, or is used for any particular purpose, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to any particular arrangement. In re Kuhle, 536 F.2d 553,555,188 USPQ 7,9 (CCPA 1975)
Claims 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Bengtsson et al and Truax as applied to claim 1 above, and further in view of Stewart (US 2020/0015937).
Regarding claim 6, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose the first and second posterior teeth regions each comprises a buccal surface configured to extend at least 2 mm over the patient's gingiva when worn.
Stewart teaches a buccal surface of an appliance (5) configured to extend at least 2 mm over the patient’s gingiva when worn (see figure 5A-C and par 83 which discloses trimming and wearing the aligner with 2 mm beyond the gum line) for the purpose of retaining strength and moving teeth more efficiently (par 57).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of applicant’s filing to modify Kimura/Bengtsson/Truax to have the first and second posterior teeth regions each comprises a buccal surface configured to extend at least 2 mm over the patient's gingiva when worn as taught by Stewart for the purpose of retaining strength and moving teeth more efficiently.
Regarding claim 11, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose the unitary body includes a gingival support region.
Stewart teaches the unitary body (5) includes a gingival support region (9, see figure 5A).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura/Bengtsson/Truax to have the unitary body includes a gingival support region as taught by Stewart for the purpose of contacting a tissue adjacent to the teeth.
Claims 7-8 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Bengtsson et al and Truax as applied to claim 1 above, and further in view of Kuo et al (US 2011/0269092).
Regarding claim 7-8, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose the unitary body includes an attachment configured to attach an elastic and the unitary body includes a slot configured to attach an elastic.
Kuo teaches a unitary body (appliance 40) includes an attachment structure, specifically a slot (slot 42, see figure 3A) configured to attach an elastic (par 38)
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kimura/Bengtsson/Truax to have the unitary body includes an attachment structure configured to attach an elastic and the unitary body includes a slot configured to attach an elastic as taught by Kuo for the purpose of accommodating the external force of an elastic member.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Bengtsson et al and Truax as applied to claim 1 above, and further in view of Wu et al (US 2015/0238280).
Regarding claims 9-10, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose the unitary body includes a mandibular advancement feature, wherein the mandibular advancement feature includes a block, a ramp or other surface shape extending from the unitary body and the mandibular advancement feature comprises a ramp surface extending from of the unitary body.
However, Wu teaches a unitary body (shells 114/116) includes a mandibular advancement feature (jaw element 106/108, par 50 discloses the jaw elements which discloses a repositions the jaw) and the mandibular advancement feature comprises a ramp (first and second surface 128 and/or 126) extending from of the unitary body (see figure 1A) for the purpose of moving the jaw less painfully into a desired position (par 41).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura/Bengtsson/Truax to have the unitary body includes a mandibular advancement feature and the mandibular advancement feature comprises a ramp surface extending from of the unitary body as taught by Wu for the purpose of moving the jaw less painfully into a desired position.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Bengtsson et al and Truax as applied to claim 1 above, and further in view of Cao et al (US 2009/0191502).
Regarding claim 12, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose the unitary body includes a plurality of ridges.
Cao teaches a unitary body (11) includes a plurality of ridges (12) for the purpose of providing desired tooth movement (par 29).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura/Bengtsson/Truax to have the unitary body includes a plurality of ridges for the purpose of providing desired tooth movement.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Bengtsson et al and Truax as applied to claim 1 above, and further in view of Phan et al (US 2002/0192617), herein known as Phan ‘617.
Regarding claim 13, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose a bias attached to or integral with the unitary body.
Phan ‘617 teaches a unitary body (polymeric shell 12) with an attached bias (spring 60) for the purpose of applying forces to one or more teeth (par 20).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura/Bengtsson/Truax to include a bias element attached to or integral with the unitary body as taught by Phan ‘617 for the purpose of applying forces to one or more teeth.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Bengtsson et al and Truax as applied to claim 1 above, and further in view of Kopelman (US 2015/0216627).
Regarding claim 14, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose an interproximal support feature comprising one or more open spaces.
Kopelman teaches an interproximal support feature comprising one or more open spaces (discontinuity 254, see figure 2F) for the purpose of eliciting movement between teeth (par 119).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura/Bengtsson/Truax to have an interproximal support feature comprising one or more open spaces as taught by Kopelman for the purpose of eliciting movement between teeth.
Regarding claim 15, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose wherein the unitary body comprises a first material, wherein the device further comprises an interproximal support feature comprising a second material, wherein the second material is less rigid than the retainer material.
Kopelman teaches a unitary body made of a first material (polymeric material par 104) an interproximal support feature comprising a second material (elastic member 252), wherein the second material is less rigid than the retainer material (par 119 discloses the elastic member being made of an elastic material whereas the body of the unitary body/retainer material is rigid) for the purpose of eliciting movement between teeth (par 119).
. Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura/Bengtsson/Truax to have a unitary body made of a first material, an interproximal support feature comprising a second material, wherein the second material is less rigid than the retainer material as taught by Kopelman for the purpose of eliciting movement between teeth.
Regarding claim 16, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose an interproximal support feature having a rigidity that is less rigid than the unitary body.
Kopelman teaches an interproximal support feature having a rigidity that is less rigid than the unitary body (par 119 discloses the elastic member being made of an elastic material whereas the body of the unitary body is a rigid material) for the purpose of eliciting movement between teeth (par 119).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura/Bengtsson/Truax to have an interproximal support feature having a rigidity that is less rigid than the unitary body as taught by Kopelman for the purpose of eliciting movement between teeth.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Bengtsson et al and Truax as applied to claim 1 above, and further in view of Phan et al (US 6,524,101), herein known as Phan ‘101.
Regarding claim 17, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose the unitary body is comprised of a material that has a Young's modulus of between about .01 and 5 GPa.
However, Phan ‘101 teaches the body comprised of a material that has a Young's modulus of between about .01 and 5 GPa (col 6, lines 55-60 discloses the stiffness be between 0.5 to 5).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective ng date of the claimed invention to modify Kimura/Bengtsson/Truax to have the retainer material with a Young's modulus of between about .01 and 5 GPa as taught by Phan ‘101 for the purpose of providing a controlled stiffness and structure of the body that enables repositioning of the teeth at a desired rate.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Bengtsson et al and Truax as applied to claim 1 above, and further in view of Zegarelli (US 2009/0136893).
Regarding claim 18, Kimura/Bengtsson/Truax disclose the claimed invention as set forth above in claim 1, but fails to disclose the unitary body is comprised of a material that comprises nylon.
However, Zegarelli teaches the material of the dental appliance being nylon (par 43).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura//Bengtsson/Truax to have the unitary body is comprised of a nylon as disclosed by Zegarelli for the purpose of providing a supportive hardened material which can be supportive.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al in view of Truax, Bengtsson et al, and Sambu et al.
Regarding claim 19, Kimura discloses a dental device (appliance 100) comprising:
a unitary body (removable shell 102, see figures 1A-B) including:
an anterior teeth region (see annotated figure 1B) configured to hold a patient's anterior teeth within an anterior teeth pocket having lingual and occlusal sides (par 67 and figures 1A-B),
a first posterior teeth region and a second posterior teeth region (see annotated figure 1B) each configured to hold the patient's molars in a posterior teeth pocket having lingual and occlusal sides (par 67 discloses the positioning of the shell over the teeth of the patient);
a palatal region (arch element 103/104) configured to extend between the first and second posterior teeth regions and adjacent to the patient's palate (see figure 1A-B and par 68-69 discloses the arch element 103/104 extending between the posterior sides of the appliance), wherein the palatal region is thicker than the occlusal side of the first and second posterior teeth regions (par 135 discloses the arch element being formed of a second layer and that the second layer can he a thicker later of material than the first layer which is the material of the shell 102, therefore the palatal region is thicker than the layer on the posterior occlusal surfaces), and
the palatal region starts at a transition curve that is configured to link multiple patient’s molars (see paragraph 76-77 discloses the application of movement force from the arch element onto the interior posterior molars in concurrent teeth, thus creating a transition curve between the ridge points of the crown surfaces).
Kimura fails to disclose wherein a thickness of the palatal region gradually increases starting at a transition curve that is configured to link multiple ridge points of crown surfaces of the patient’s molars when the device worn, wherein the gradual increase in thickness ends at a middle portion of the palatal region, a top surface of the palatal region is smoother than a bottom surface of the palatal region, further wherein the bottom surface is configured to be worn adjacent to the patient's palate; and an identifying code on one or more of: the bottom surface of the palatal region or a posterior edge of the palatal region.
Truax teaches a palatal region (appliance 38) has a thickness of the palatal region that gradually increases starting at the transition curve (see figure 10, where the palatal region thickness gradually increases from the undercut 12 that is located at the ridge point of the crown and is the starting point of the palatal region being at the undercut 12), wherein the gradual increase in thickness ends at a middle portion of the palatal region (see figure 10) for the purpose of providing securely, offers greater stability and more efficient tooth and supporting alveolar bone movement due to the appliance (col 5, lines 6-10).
Therefore, it would be obvious to one of ordinary skill in the art at the time of invention to modify Kimura/Bengtsson to modify the transition curve to be located at the ridge point of the crown of the patient’s molars and have a thickness of the palatal region gradually increases starting at the transition curve located at the ridge point of the crown of the patient’s molar, wherein the gradual increase in thickness ends at a middle portion of the palatal region as taught by Truax for the purpose of providing securely, offers greater stability and more efficient tooth and supporting alveolar bone movement due to the appliance.
Bengtsson teaches a palatal device (base plate 2) with a top surface (convex surface 8) which is smoother than a bottom surface (inner surface 16) of the palatal device (see figures 6-8, where the inner surface 16 has a stimulating member 9 which provides a texture not found on the convex surface 8), and the bottom surface is configured to be worn adjacent to the patient’s palate (see page 7, line 15-20 discloses the cones are positioned in a central position of the palatal plate and used or positioned adjacent to the tongue of the patient)for the purpose of providing stimulation (page 7, line 17).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Kimura to have a top surface of the palatal region is smoother than a bottom surface of the palatal region, further wherein the bottom surface is configured to be worn adjacent to the patient's palate as taught by Bengtsson for the purpose of providing oral/lingual stimulation.
Sambu teaches including an identification code (readable identifier 720) on a surface of a palatal region (see figure 3B and par 27) for the purpose of facilitating subsequent manufacturing operations (par 27).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kimura to have an identification code placed on the palatal region as taught by Sambu for the purpose of facilitating subsequent manufacturing operations. Sambu fails to specifically disclose the positioning of the identification code on a bottom surface or posterior edge of the palatal region.
However, positioning the identification code on a bottom surface or posterior edge of the palatal region is considered an obvious matter of design choice lacking in criticality, well within the skill of an ordinary artisan, for the purpose of providing the information of the identification code to a manufacturer or user. Furthermore, absent a teaching as to criticality that having the angles be different provides an advantage, solves any stated problem, or is used for any particular purpose, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to any particular arrangement. In re Kuhle, 536 F.2d 553,555,188 USPQ 7,9 (CCPA 1975)
Response to Arguments
Applicant’s arguments with respect to claims 1 and 19 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANNEL N BELK whose telephone number is (571)272-9671. The examiner can normally be reached Mon. -Fri. 11:30 am - 3:30 pm.
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/S.N.B./ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
1/8/2026