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 Arguments
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive. Applicant has argued that Kimura fails to provide for the new claim limitations of “wherein the polymeric shell is configured not to contact occlusal or buccal surfaces of the patient’s teeth along the bridge region” however such language is broad and only requires that along the bride region the polymer shell does not contact the occlusal or buccal surfaces and as such the cited portion of the bridge of Kimura for claims 1 and 46 is only along the lingual region of teeth. Further claim 51 is now rejected by citing to figure 12a as not requiring any bridging region.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14, 19, 46, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimura et al. (US 2016/0081769 A1).
Regarding claim 1, Kimura discloses a system for expanding a patient's lower dental arch (title and abstract disclosing a system for arch expansion, paragraph [0042] disclosing the term arch includes the lower arch), the system comprising:
a series of expander devices each configured to incrementally expand the patient's lower dental arch toward a target arch configuration based on a treatment plan (paragraph [0055] lines 1-6, paragraph [0078] all disclosing the appliances are for either the upper or lower jaw),
wherein each expander device of the series of expander devices comprises a polymeric shell comprising (paragraph [0042] lines 1-7 disclosing a polymer shell expander):
a first tooth-receiving portion shaped to receive one or more first teeth (paragraph [0069] all disclosing the appliance will have a first tooth receiving portion for either the left or right side, Such as Fig. 11 teeth of line end point of 1102 side), the first tooth-receiving portion having
a first lingual side (Figs. 7/11 showing left and right lingual sides of the shell),
a first buccal side (Figs. 7/11 showing left and right buccal sides of the shell) and
a first occlusal side (Figs. 7/11 showing left and right occlusal sides of the shell);
a second tooth-receiving portion shaped to receive one or more second teeth (paragraph [0069] all disclosing the appliance will have a second tooth receiving portion for either the left or right side which would be the side opposite of the first side above, such as Fig. 11 the teeth receiving cavities opposite of 1102 line end point), the second tooth-receiving portion having
a second lingual side (Figs. 7/11 showing left and right lingual sides of the shell),
a second buccal side (Figs. 7/11 showing left and right buccal sides of the shell) and
a second occlusal side (Figs. 7/11 showing left and right occlusal sides of the shell);
and a bridge region coupling the first lingual side to the second lingual side (Fig. 7 lingual area of the shell anterior of element 705),
wherein the bridge region is configured to maintain an expansion width between the first lingual side and the second lingual side that applies an expansion force between the one or more first teeth and the one or more second teeth when the device is worn on a patient's lower dental arch to expand the patient's lower dental arch (paragraph [0042] lines 8-11 disclosing the arch element that provides the expansion width maintained),
wherein the first lingual side and the second lingual side are configured to transmit all or some of the expansion force (paragraph [0065] all disclosing the force is applied to the teeth by the teeth being within the cavities and thus the expansion force cited above by being wider than the teeth would be applied/transmitted by the lingual sides of the appliance against the teeth);
wherein the polymeric shell is configured not to contact occlusal or buccal surfaces of the patient’s teeth along the bridge region (Fig. 7 the polymer shell along the bridge region 705 itself does not contact occlusal or buccal surfaces but the bridge region of the polymeric shell only contacts the lingual portion of the teeth),
further wherein the expansion widths of the expander devices in the series of expander devices increase over a course of the series (paragraph [0087] all disclosing successive appliances increase in width).
Regarding claim 2, Kimura further discloses where the first and second lingual sides are stiffer than the first and second buccal sides of the first and second occlusal sides (paragraph [0161] lines 3-5 disclosing the tab 705 in Fig. 7 that extends to both the left and right lingual sides provides additional rigidity and thus would be stiffer than the occlusal and buccal sides of the left and right sides).
Regarding claim 3, Kimura further discloses where the first and second lingual sides are thicker than the first and second occlusal sides or the first and second buccal sides (paragraph [0161] lines 3-5 disclosing the tab 705 in Fig. 7 that extends to both the left and right lingual sides and shows a increase thickness of portions of the lingual sides as compared to the occlusal or buccal sides, further paragraphs [0162]-[0164] disclosing that some “lingual sections” can have a rib feature that is a thicker region than other shell regions).
Regarding claim 4, Kimura further discloses where the polymeric shell of each expander device is made of a single polymer material (paragraph [0116] all disclosing the appliance can be made of “at least one polymeric material’).
Regarding claim 5, Kimura further discloses where the expansion width between the first lingual side and second lingua side of each subsequent expander device of the series of expander devices is wider than a previous expander device in the series (paragraph [0055] all disclosing the width increases incrementally with each device and the device of Fig. 7/11 when having wider arrangements would have an increase width between lingual sides, paragraph [0049] all the expansion width is specific to the treatment stage).
Regarding claim 6, Kimura further discloses wherein each expander device of the series of expander devices is configured to apply the expansion forces with a magnitude and direction in accordance with a stage of an arch expansion treatment plan (paragraphs [0049]-[0050] disclosing the forces are specific for each treatment stage and having magnitudes of 3-9 N outwards).
Regarding claim 7, Kimura further discloses where the expansion force of each expander device of the series of expander devices is between 1 Newton (N) and 25 Newton (paragraph 0050] lines 4-5 disclosing the force is between 3-9 newtons).
Regarding claim 8, Kimura further discloses where the bridge region of at least one of the expander devices of the series of expander devices is configure to contact one or more anterior teeth when the device is worn on the patient’s lower dental arch (Fig. 7 anterior region labial portion acts as the bridge region and is contact one or more anterior teeth of the lower arch when worn).
Regarding claim 9, Kimura further discloses where the bridge region of at least one of the expander devices of the series of expander devices is configured to apply a second expansion force on or ore more anterior teeth (paragraph [0163] lines 1-5 disclosing the ribs can be placed on different regions and provide forces in specialized directions thus resulting in a different forces on the anterior teeth than the premolar/molars where the ribs would be).
Regarding claim 10, Kimura further discloses where the first lingual side is thicken than the first buccal side and the second lingual side is thicker than the second buccal side for each of the expander devices of the series of expander devices (paragraph [0161] lines 3-5 disclosing the tab 705 in Fig. 7 that extends to both the left and right lingual sides and shows an increase thickness of portions of the lingual sides as compared to the occlusal or buccal sides, further paragraphs [0162]-[0164] disclosing that some “lingual sections” can have a rib feature that is a thicker region than other shell regions).
Regarding claim 11, Kimura further discloses where the first tooth receiving portion and the second tooth receiving portion for each of the expander devices of the series of expander devices are shaped to receive only molars, premolars, or molars and premolars (Fig. 7/11 the portions of the expanders that receive the molar/premolars or molars and premolars would be the first and second tooth receiving portions).
Regarding claims 12 and 13, Kimura further discloses where the bridge region is configured to conform to a lingual surface of the patient’s lower anterior teeth of the dental arch when the device is worn by the patient (Fig. 7/11 the region of the expander that contacts the lingual surfaces of the anterior teeth is shown as conforming to those teeth).
Regarding claim 14, Kimura further discloses wherein the bridge region comprises tooth receiving portions having one or more of: a buccal side, a lingual side, and an occlusal side (Fig. 7/11 the bridge region of the anterior teeth having buccal, lingual, and occlusal sides).
Regarding claim 19, Kimura further discloses where one or both of the first occlusal side and the second occlusal side for at least one of the expander devices of the series of expander devices has a thickness configured to disocclude anterior teeth of the patient’s lower jaw (Fig. 7/11 the expander devices having occlusal surfaces with a thickness and thus would cause disocclusion of the anterior teeth when worn as the occlusal surfaces of teeth would be separated by the thickness of the device).
Regarding claim 46, Kimura discloses a system for expanding a patient's lower dental arch (title and abstract disclosing a system for arch expansion, paragraph [0042] disclosing the term arch includes the lower arch), the system comprising:
a series of expander devices each configured to incrementally expand the patient's lower dental arch toward a target arch configuration based on a treatment plan (paragraph [0055] lines 1-6, paragraph [0078] all disclosing the appliances are for either the upper or lower jaw),
wherein each expander device of the series of expander devices comprises a polymeric shell comprising (paragraph [0042] lines 1-7 disclosing a polymer shell expander):
at last one tooth-receiving portion shaped to receive one or more first teeth of a first side of a patients lower dental arch (paragraph [0069] all disclosing the appliance will have a first tooth receiving portion for either the left or right side, Such as Fig. 11 teeth of line end point of 1102 side), having
a buccal side (Figs. 7/11 showing left and right buccal sides of the shell) and
an occlusal side (Figs. 7/11 showing left and right occlusal sides of the shell);
and a lingual portion coupled to the at least one tooth receiving portion and arranged to contact lingual surfaces of one or more second teeth on an opposite side of the patient’s lower dental arch when the device is worn on the patient’s lower dental arch (Figs. 7/11 showing left and right lingual side portions of the shell that would be in contact with lingual surfaces that would be on an opposite side of the lower jaw, such as the left side lingual surface would be opposite the right side buccal and occlusal surfaces, or the right side lingual surface would be opposite the left side occlusal/buccal surfaces and would be coupled to the opposite side via the bridge portion cited below),
and a bridge portion shaped and sized to transmit an arch expanding force to the lingual portion in accordance with a corresponding stage of the treatment plan (paragraph [0042] lines 8-11 disclosing the arch element that provides the expansion width maintained and paragraph [0065] all disclosing the force is applied to the teeth by the teeth being within the cavities and thus the expansion force cited above by being wider than the teeth would be applied/transmitted by the lingual sides of the appliance against the teeth),
wherein the polymeric shell is configured not to contact occlusal or buccal surfaces of the patient’s teeth along the bridge region ( The polymer shell along the bridge region itself of fig. 7 element 705 and Fig. 11 element 1109 does not contact occlusal or buccal surfaces but the polymeric shell along the bridge region only contacts the lingual portion of the teeth).
Regarding claim 51, Kimura discloses a system for expanding a patient's lower dental arch (title and abstract disclosing a system for arch expansion, paragraph [0042] disclosing the term arch includes the lower arch), the system comprising:
a series of expander devices each configured to incrementally expand the patient's lower dental arch toward a target arch configuration based on a treatment plan (paragraph [0055] lines 1-6, paragraph [0078] all disclosing the appliances are for either the upper or lower jaw),
wherein each expander device of the series of expander devices comprises a polymeric shell comprising (paragraph [0042] lines 1-7 disclosing a polymer shell expander):
a polymer shell defining a plurality of tooth receiving cavities shaped to receive one or more teeth of a patient’s lower dental arch(paragraph [0069] all disclosing the appliance will have a tooth receiving portion for the left and right sides shaped as cavities, Such as Fig. 12a), the tooth-receiving portion having
a lingual side (Fig. 12a showing left and right lingual sides of the shell),
a buccal side (Fig. 12a showing left and right buccal sides of the shell) and
an occlusal side (Fig. 12a showing left and right occlusal sides of the shell);
wherein the plurality of the plurality of tooth-receiving cavities is shaped to apply tooth aligning forces to straighten one or more of the plurality of teeth in accordance with a stage of a treatment plan when the polymer shell is worn on the patient's lower dental arch(paragraph [0077] all disclosing the appliances simultaneously treat misalignment and include correction of tipping thus straightening of teeth);
and at least a portion of the lingual side is stiffer than the buccal side or the occlusal side of the plurality of tooth-receiving cavities (paragraph [0161] lines 3-5 disclosing the lingual side of the appliance having additional rigidity and thus would be stiffer than the buccal and occlusal sides, Fig. 12a elements 1214),
and has an expansion width, wherein the lingual side is configured to apply an expansion force between opposing teeth in accordance with the stage of the treatment plan when the polymer shell is worn on the patient's lower dental arch (paragraph [0161] lines 1-5 the lingual side is configured to apply palatal expansion),
wherein the polymer shell is configured not to contact occlusal or buccal surfaces of the patient’s anterior teeth (Fig. 12a the shell does not have anterior teeth section),
further wherein the expansion widths of the expander devices in the series of expander devices increase over a course of the series (paragraph [0087] all disclosing successive appliances increase in width).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (US 2016/0081769 A1).
Regarding claim 15, Kimura discloses structure substantially identical to the instant application as discussed above and further discloses where posterior portions of the expander include one or more openings which would allow exfoliation of one more primary teeth (Fig. 12c openings at 1212) but fails to explicitly disclose where the anterior/bridge portion of the expander also have such openings, however it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the openings into the bridge portions of the expanders as well for the purpose of providing for such bridge portion to not be visible to people and/or to provide a more secure fitment of the bridge surface and/or to allow for position or orientation of a tooth to be adjusted when the appliance is worn for expanding of a palate as taught by Kimura (paragraph [0176] disclosing some portion would not be visible to people, paragraph [0177]-[0178] disclosing such openings would provide for better fitment and increase ability to control the application of forces and would further allow additional position/orientation of a tooth be adjusted when the appliance is expanding the palate).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (US 2016/0081769 A1) in view of Cam et al. (US 2019/000593 A1).
Regarding claim 16, Kimura discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the expander includes a plurality of attachment cavities configured to couple to an attachment bonded to one or more of the patient’s teeth.
However, Cam discloses a system for expanding a patient's lower dental arch (title and abstract disclosing a system for arch expansion, paragraph [0042] disclosing the term arch includes the lower arch), and the expanders including a plurality of attachment cavities configured to couple to attachments bonded to a patient’s teeth (Fig. 14c attachment elements 1481/1482, and cavities Fig. 14b elements 1490).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of cavities for attachments bonded on teeth as taught by Cam into the expander system as taught by Kimura for the purpose of providing for increased engagement between the teeth and the device as taught by Cam (paragraph [0161] all).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (US 2016/0081769 A1) in view of Falkel et al. (US 2018/0078343 A1).
Regarding claims 17 and 18, Kimura discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the expander includes one or more bite adjustment structures that are configured to promote mandibular advancement by a shape and arrangement to contact a patient’s upper dental arch or dental device on the upper arch nor shaped and arranged to contact one or more bite adjustment structures on a device on the upper arch.
However, Falkel discloses a system for expanding a patient's lower dental arch (title and abstract disclosing a system, paragraph [0006] disclosing the use of the series for mandibular advancement and expanding), and the expanders including a plurality a plurality of bite adjustment structures that are shaped and arranged to contact bite adjustment structures on a dental device on an upper arch (Fig. 1 elements 12a/b that advance elements 14a/b).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of one or more bite adjustment structures shape and arranged to contact bite adjustment structures of an upper device as taught by Felkel into the expander system as taught by Kimura for the purpose of providing for concurrently advancing the mandible while expanding the mandible for airway development as taught by Felkel (paragraph [0009] all).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
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 MATTHEW P SAUNDERS whose telephone number is (571)270-3250. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at (571) 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.P.S/Examiner, Art Unit 3772 04/04/2026
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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