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 .
Priority
This application claim priority to provisional application 62/429692 filed on 12/2/2016, however, it is noted that support for the claimed limitation including the palatal region having an anterior and posterior region wherein at least a portion of the anterior region is thinner than the posterior region along a midline with respect to claims 1 and 14. Further with respect to claim 18 support for the palatal region having an anterior and posterior region wherein at least a portion of the posterior region is thinner than the anterior region along a midline is not found in the above provisional application. It is noted that paragraph 61 of the provisional provides support for the palatal region being thicker at a midline is provided. It is noted that the claims are entitled to the priority date of 62/542,750 which is 8/8/2017. It is noted that support for the above limitations is provided in figure 10b and par. 43. Therefore, the effective filling date of all of the claims of the current application are 8/8/2017.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-20 are 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.
With respect to claim 18, the applicant claims the posterior region is thinner than the anterior region and then further claims “an anterior half of the palatal region is thinner than a posterior half of the palatal region”. It is unclear how the claimed sections can have the claimed different thicknesses. It is noted that the limitation is being interpreted as a posterior half of the palatal region is thinner than an anterior half of the palatal region, however, the applicant should amend the claim to clarity what is being claimed. Claims 19-20 are rejected for depending from claim 18.
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(s) 1-4, 7-9, 14-15, 17-19 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (2016/0081769).
See above regarding the effective filling date being 8/8/2017, therefore the above application applies as prior art since it was published more than a year (3/24/2016) before the effective filling date of the current invention.
With respect to claim 1, Kimura teaches a series of palatal expanders having a sequence and configured to be sequentially worn by a patient in a palatal expansion treatment (par. 42), a first palatal expander in the series of palatal expanders comprising: a left tooth-engagement region having one or more tooth-receiving cavities shaped to receive one or more posterior teeth on a left side of a maxilla of the patient; a right tooth-engagement region having one or more tooth-receiving cavities shaped to receive one or more posterior teeth on a right side of the maxilla of the patient (see fig. 1B annotated figure below); and a palatal region extending between the left and right tooth-engagement regions and configured to traverse the patient's palate when the first palatal expander is worn by the patient (see figs 1b, pars. 96, 100, see annotated figure below, such that the palatal region is one single valley and one single ridge extending between the left and right tooth engagement regions, such that in the annaoted figure below the palatal region would be the ridge including the posterior region and the valley including the anterior region), wherein the palatal region includes an anterior region and a posterior region (see annotated figure), wherein a portion of the anterior region and a posterior region (see annotated figure below, such the anterior region is a region of a valley in the anterior portion and the posterior region is a region of a ridge in the posterior portion, see pars. 97-98), wherein a portion of the anterior region along a midline of the palatal region is thinner than the posterior region along the midline of the palatal region (see annotated figures, such that the anterior region is a valley and the posterior region is a ridge, such that the valley is thinner than the ridge), wherein the midline of the palatal region run though a middle of the palatal region from an anterior end of the palatal region to a posterior end of the palatal region, wherein an anterior half of the palatal region is thinner than a posterior half of the palatal region (see annotated figure below, fig. 1B, pars. 57, 73, 75 96-99, 102, such that the side facing the palate follow the contours of the palate and the opposite side includes reinforcement members 105 which increase the thickness along the midline of the palatal region in the area that they are placed. It is noted that a portion of the anterior region without the reinforcement member 105 is thinner than the posterior portion, which is a region in the posterior portion of the palatal element with the reinforcement member). Such that the palatal region is only a single ridge and a single valley, such that an anterior half (i.e. the valley which is anterior relative to the ridge) is thinner than a posterior half (i.e. the ridge of the palatal region). Kimura further teaches at least a portion of the palatal region is configured to have a clearance from the patient's mid-palatal region when the first palatal expander is worn by the patient (pars. 75, 102, 103, 111). It is noted that Kimura teaches the invention as substantially claimed and discussed above, however does not specifically teach the clearance is between 0.1 and 5 millimeters. However, it is noted that Kimura teaches the clearance for the same reason as that applicant such as for the comfort of the patient and to prevent pressure points (see pars. 75, 103, 111). Therefore, it is noted that it would have been obvious to one having ordinary skill in the art before the effective filling date to ensure that the clearance is between 0.1 and 5 millimeters as a matter of obvious design choice. It is noted that the gap would need to be small to ensure that the expander still fit properly within the mouth and further the mouth is of a limited size. Since the prior art teaches the clearance for the same reason as the applicant and further the applicant does not disclose the specific size of the gap provides an advantage or unexpected results, the specific size of the gap would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filling date of the invention. Such that the gap is selected to be small so as to not provide the palatal region to not interfere with natural speech but large enough to provide the clearance to prevent pressure points. See pars. 186-187 regarding the combination of the different embodiments. Such that the reinforcement elements on the arch expanding element in which the left and right tooth engagement regions are not connected are taught as being an obvious variant.
PNG
media_image1.png
359
604
media_image1.png
Greyscale
Figure A
PNG
media_image2.png
341
604
media_image2.png
Greyscale
Figure B
With respect to claim 2, Kimura further teaches wherein the anterior region comprises a portion that is removed or curved inward (see figures above, such that it is curved inwards towards the palate, i.e. in a direction from the teeth inwards towards the palate).
With respect to claim 3, Kimura further teaches wherein at least one of the left and right tooth-engagement regions comprises surfaces configured to cover occlusal surfaces of the patient's teeth when the first palatal expander is worn by the patient (see figs 1B).
With respect to claim 4, Kimura further teaches wherein at least one of the left and right tooth-engagement regions comprises openings or holes arranged to align with occlusal surfaces of the patient's teeth such that the occlusal surfaces of the patient's teeth are not covered when the first palatal expander is worn by the patient (see fig. 12c, par. 77 and 186-187 regarding the combination of the different embodiments).
With respect to claim 7, Kimura further teaches wherein the palatal region has a thickness that varies between the left and right tooth-engagement regions (see fig. 1b, such that the thickness varies between the tooth engagement portions relative to the reinforcement members 105, such that in the region with ridge is thicker than the region with the valley).
With respect to claim 8, Kimura further teaches wherein the palatal region further comprises a concave region along a palatal surface at a lingual portion of the patient near a gingival line of the patient when the first palatal expander is worn by the patient (see annotated figure below).
PNG
media_image3.png
584
460
media_image3.png
Greyscale
With respect to claim 9, Kimura further teaches wherein the series of palatal expanders further comprises a holder palatal expander configured to apply a retentive force to retain the patient's palate (pars. 50, 64, 142, such that the second arch element is used to maintain the space, therefore it is a holder expander in that it is holding the expansion from the first arch expander, see claims 17 20-22). Kimura does not specifically teach the holder palatal expander having a shape corresponding to a previous palatal expander in the series of palatal expanders, however, the holder palatal expander is configured to be used after a previous expander in which the previous expander has expanded the arch and is designed to hold the arch in the previously expanded configuration, the holder expander has a shape corresponding to a pervious expander.
With respect to claim 14, Kimura teaches method of forming a series of palatal expanders having a sequence and configured to be sequentially worn by a patient in a palatal expansion treatment, the method comprising forming a first palatal expander in the series of palatal expanders by forming a left tooth-engagement region having one or more tooth-receiving cavities shaped to receive one or more posterior teeth on a left side of a maxilla of the patient, forming a right tooth-engagement region having one or more tooth-receiving cavities shaped to receive one or more posterior teeth on a right side of the maxilla of the patient; and forming a palatal region extending between the left and right tooth-engagement regions and configured to traverse the patient's palate when the first palatal expander is worn by the patient (see figs. 1B, explanation above, such that the device in fig. 1B is formed, see annotated figure above including the palatal region which includes one valley and one ridge), wherein the palatal region includes an anterior region and a posterior region, wherein a portion of the anterior region along a midline of the palatal region is thinner than the posterior region along the midline (see annotated figures above, such that the anterior region is a valley and the posterior region is a ridge, such that the valley is thinner than the ridge), wherein the midline of the palatal region runs through a middle of the palatal region from an anterior end of the palatal region to a posterior end of the palatal region (see detailed explanation above with respect to claim 1), wherein an anterior half of the palatal region is thinner than a posterior half of the palatal region (see annotated figure above, fig. 1B, pars. 57, 73, 75 96-99, 102, such that the side facing the palate follow the contours of the palate and the opposite side includes reinforcement members 105 which increase the thickness along the midline of the palatal region in the area that they are placed. It is noted that a portion of the anterior region without the reinforcement member 105 is thinner than the posterior portion, which is a region in the posterior portion of the palatal element with the reinforcement member). Such that the palatal region is only a single ridge and a single valley, such that an anterior half (i.e. the valley which is anterior relative to the ridge) is thinner than a posterior half (i.e. the ridge of the palatal region). Kimura further teaches at least a portion of the palatal region is configured to have a clearance of from the patient's mid-palatal region when the first palatal expander is worn by the patient (pars. 75, 103, 111). It is noted that Kimura teaches the invention as substantially claimed and discussed above, however does not specifically teach the clearance is between 0.1 and 5 millimeters. However, it is noted that Kimura teaches the clearance for the same reason as that applicant such as for the comfort of the patient and to prevent pressure points (see pars. 75, 103, 111). Therefore, it is noted that it would have been obvious to one having ordinary skill in the art before the effective filling date to ensure that the clearance is between 0.1 and 5 millimeters.as a matter of obvious design choice. It is noted that the gap would need to be small to ensure that the expander still fit properly within the mouth and further the mouth is of a limited size. Since the prior art teaches the clearance for the same reason as the applicant and further the applicant does not disclose the specific size of the gap provides an advantage or unexpected results, the specific size of the gap would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filling date of the invention. Such that the gap is selected to be small so as to not provide the palatal region to not interfere with natural speech but large enough to provide the clearance to prevent pressure points. See pars. 186-187 regarding the combination of the different embodiments. Such that the reinforcement elements on the arch expanding element in which the left and right tooth engagement regions are not connected are taught as being an obvious variant.
With respect to claim 15, Kimura further teaches wherein forming the palatal region comprises removing a portion of the anterior region or curving a portion of the anterior region inward (see fig. 1B, such that the anterior portion is curved inwards towards the palate when formed).
With respect to claim 17, Kimura further teaches wherein at least one of the left and right tooth-engagement regions comprises openings or holes arranged to align with occlusal surfaces of the patient's teeth such that the occlusal surfaces of the patient's teeth are not covered when the first palatal expander is worn by the patient (see fig. 12c, par. 77 and 186-187 regarding the combination of the different embodiments).
With respect to claim 18, Kimura teaches a series of palatal expanders having a sequence and configured to be sequentially worn by a patient in a palatal expansion treatment (par. 55), a first palatal expander in the series of palatal expanders comprising: a left tooth-engagement region having one or more tooth-receiving cavities shaped to receive one or more posterior teeth on a left side of a maxilla of the patient; a right tooth-engagement region having one or more tooth-receiving cavities shaped to receive one or more posterior teeth on a right side of the maxilla of the patient; and a palatal region extending between the left and right tooth-engagement regions and configured to traverse the patient's palate when the first palatal expander is worn by the patient (see fig. 1B, such that the palatal region is one ridge and one valley, see annaoted figure below), wherein the palatal region includes an anterior region and a posterior region, wherein a portion of the posterior region along a midline of the palatal region is thinner than the anterior region along the midline of the palatal region (see annotated figure below, such that the anterior region is a ridge and the posterior region is a valley, such that the valley is posterior to the ridge of the anterior portion), wherein the midline of the palatal region runs through a middle of the palatal region from an anterior end of the palatal region to a posterior end of the palatal region, wherein an anterior half of the palatal region is thinner than a posterior half of the palatal region (see annotated figure below, fig. 1B, pars. 57, 73, 75 96-99, 102, such that the side facing the palate follow the contours of the palate and the opposite side includes reinforcement members 105 which increase the thickness along the midline of the palatal region in the area that they are placed. It is noted that a portion of the posterior region without the reinforcement member 105 is thinner than the anterior portion, which is a region in the anterior portion of the palatal element with the reinforcement member). Such that the posterior half of the palatal region is the single valley of the palatal region and the anterior half is the ridge, such that the posterior half is thinner than the anterior half as claimed. Kimura further teaches at least a portion of the palatal region is configured to have a clearance of from the patient's mid-palatal region when the first palatal expander is worn by the patient (pars. 75, 103, 111). It is noted that Kimura teaches the invention as substantially claimed and discussed above, however does not specifically teach the clearance is between 0.1 millimeters and 5 millimeters. However, it is noted that Kimura teaches the clearance for the same reason as that applicant such as for the comfort of the patient and to prevent pressure points (see pars. 75, 103, 111). Therefore, it is noted that it would have been obvious to one having ordinary skill in the art before the effective filling date to ensure that the clearance is between 0.1 millimeters and 5 millimeters as a matter of obvious design choice. It is noted that the gap would need to be small to ensure that the expander still fit properly within the mouth and further the mouth is of a limited size. Since the prior art teaches the clearance for the same reason as the applicant and further the applicant does not disclose the specific size of the gap provides an advantage or unexpected results, the specific size of the gap would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filling date of the invention. Such that the gap is selected to be small so as to not provide the palatal region to not interfere with natural speech but large enough to provide the clearance to prevent pressure points.
With respect to claim 19, the palatal region has a thickness that varies between the left and right tooth-engagement regions (see fig. 1B, such that the thickness varies between the tooth engagement portions relative to the reinforcement members 105, such that in the region with ridge is thicker than the region with the valley).
With respect to claim 22, Kimura further teaches wherein the portion region includes a cut-out region at the posterior end of the palatal region (see fig. 6A, annotated figure below, such that it is curved and therefore has a cut-out such as it is not straight as fig. 6B, 186-187 regarding the combination of the different embodiments, such that for this claim the palatal region is the palatal region in annaoted figure A).
PNG
media_image4.png
501
525
media_image4.png
Greyscale
With respect to claim 24, Kimura further teaches wherein the anterior region includes a cut-out region at the anterior end of the palatal region (see fig. 6A, annotated figure below, such that it is curved and therefore has a cut-out such as it is not straight as fig. 6B, 186-187 regarding the combination of the different embodiments, such that for this claim the palatal region is the palatal region in annaoted figure B).
PNG
media_image5.png
404
475
media_image5.png
Greyscale
Claim(s) 5-6 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (2016/0081769) as applied to claim 1 above, and further in view of Hong (2017/0265967).
Kimura teaches the invention as substantially claimed and discussed above, however, does not specifically teach the first palatal expander further comprises a buccal extension configured to extend form a buccal side of at least one of the left and right teeth engagement regions, wherein a first portion of the buccal extension is configured to extends over a portion of the patient’s gingiva and be offset form the patient’s gingival to form a buccal gingival gap related to the patient’s gingiva and wherein the buccal extension is configure to flex to release the first palatal expander form the patient’s teeth when a force is applied to pull the buccal side away from the patient’s teeth or gums.
Hong teaches a dental appliance for moving teeth comprising a teeth engagement region 306 (see fig.16,18) and further with respect to claims 5 and 20, comprising a buccal extension 308 configured to extend form a buccal side of the teeth engagement region, wherein a first portion of the buccal extension is configured to extends over a portion of the patient’s gingiva and be offset form the patient’s gingival to form a buccal gingival gap related to the patient’s gingiva (see fig. 16, such that a gap is formed, the gap is where element 306 is located, i.e. it forms the gap, pars. 50, 91, 142, 144) and further with respect to claim 6, wherein the buccal extension is configured to flex to release the first palatal expander from the patient’s teeth when a force is applied to pull the buccal side away from the patient’s teeth or gums. It is noted that Hong teaches the appliance being made of a material having elasticity (par. 124) such that when a force is applied to the extension, it would flex. Therefore, Hong teaches the extension as claimed. It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kimura with the extension taught by Hong in order to assist in removing the device.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (2016/0081769) as applied to claim 1 above, and further in view of Shivapuja et al. (2016/0256240).
Kimura teaches the invention as substantially claimed and discussed above including the palatal region is integrally formed with the tooth engagement regions (pars. 72, 109, 135). With respect to claim 10, the limitation “by three-dimensional (3D) printing” is being treated as a product by process limitation; that is, that the expander is made by three-dimensional printing. As set forth in MPEP 2113, product by process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. It is noted that the expander taught by Kimura appears would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made by three-dimensional printing (see pars. 105 and 113). Kimura teaches the invention as substantially claimed and discussed above, however, does not specifically teach the palatal region comprises a biocompatible nylon material.
Shivapuja teaches a dental appliance which comprises a biocompatible nylon material (par. 112). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the material of Kimura to be a nylon taught by Shivapuja since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (see MPEP 2144.07). It is noted that the nylon is biocompatible since it is for use in a dental alinger in the mouth of a patient.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (2016/0081769) as applied to claim 1 above, and further in view of Truax et al. (5,242,304).
Kimura teaches with respect to claim 12 the invention as substantially claimed and discussed above, including wherein at least one the left and right tooth engagement regions includes an occlusal side that is thinner than the palatal region (see fig. 5, such that the palatal region 508 has both layers of material and is therefore thicker than the occlusal region of the shell having only the single layer) and a buccal side, however, does not specifically teach the buccal side is thinner than the occlusal side and a transition region between the occlusal side and the buccal side that decreases in thickness from the occlusal side to the buccal side and the buccal side of the at least one of the left and right tooth engagement regions includes an attachment region configured to couple to an attachment bonded to the patient teeth
With respect to claim 12, Truax teaches a dental device comprising a left tooth engagement region and a right tooth engagement region and a palatal region extending between the left and right tooth engagement regions (see figs. 5, 7-8), the tooth engagement regions including an occlusal side and a buccal side that is thinner than the occlusal side and a transition region between the occlusal side and the buccal side that decreases in thickness form the occlusal side to the buccal side (see annotated figure below).
PNG
media_image6.png
385
527
media_image6.png
Greyscale
With respect to claim 13, Truax further teaches wherein the buccal side of the at least one of the left and right tooth engagement regions includes an attachment region 54 configured to couple to an attachment 12 bonded to the patient teeth (see figs. 7-8).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Kimura with the buccal side and attachment region taught by Truax in order to provide better retention of the appliance and allow for the buccal regions to easily flex to accept the attachments (see abstract, col. 4, ll. 66-67, col. 5, ll. 1-2, claim 1).
Allowable Subject Matter
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
It is noted that a different embodiment and interpretation of the prior art of Kimura was used in the above rejection to teach the newly claimed limitations, therefore, the arguments with respect to the embodiment and interpretation previously used are moot in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEIDI MARIE EIDE whose telephone number is (571)270-3081. The examiner can normally be reached Mon-Fri 9:00-4:00.
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, Edelmira Bosques can be reached on 571-270-5614. 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.
/HEIDI M EIDE/Primary Examiner, Art Unit 3772 3/5/2026