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 .
Drawings
The drawings were received on October 9, 2024 and December 17, 2024. These drawings are accepted and entered.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the claimed alinger configured to align teeth with the claimed basic shape and tongue anchor point in combination with the claimed shield having protrusions (claim 36) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. It is noted that the aligner with the basic shape and tongue anchor point is illustrated in figs. 1-2 and the claimed shield with protrusions is illustrated in figure 5, however, the two combined together is not illustrated.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Acknowledgement of the substitute specification submitted on October 9, 2024. It is noted that the amendments have been accepted and entered.
The disclosure is objected to because of the following informalities: The renumbering of the paragraphs in the substitute specification is improper. See section 714, B. of the MPEP which covers amendments to the specification. Specifically:
Where paragraph numbering has been included in an application as provided in 37CFR 152(b)(6), applicants can easily refer to a specific paragraph by number when presenting an amendment. If a numbered paragraph is to be replaced by a single paragraph, the added replacement paragraph should be numbered with the same number of the paragraph being replaced. Where more than one paragraph is to replace a single original paragraph, the added paragraphs should be numbered using the number of the original paragraph for the first replacement paragraph, followed by increasing decimal numbers for the second and subsequent added paragraphs, e.g., original paragraph [0071] has been replaced with paragraphs [0071], [0071.1], and [0071.2]. If a numbered paragraph is deleted, the numbering of the subsequent paragraphs should remain unchanged
Appropriate correction is required.
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 20-38 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
With respect to claim 20, the applicant claims “an aligner” comprises “a basic shape specifying a preferred tooth position” and further claims the basic shape has “a U-shape”. It is unclear if the applicant is trying to claim the “basic shape” as a shape of the aligner, such that it is basic shape, which would be unclear since the shape of a basic shape is not a known shape, or if the applicant is trying to claim that the alinger has a specific structure that is the claimed basic shape, such as a body. It is noted that for examination purposes, the limitation is being interpreted as structure that is being claimed, and not a shape. Such as the claimed “a basic shape” is being interested as a body type structure, however, the applicant should amend the claim to clarify what is being claimed.
Further it is unclear what the applicant is trying to claim with respect to the limitation of the basic shape “specifying a preferred tooth position”. It is not clear if the applicant is trying to claim that the basic shape is a shape that is a preferred tooth/teeth position of the teeth, such that it is of a shape that is to move the teeth into the desired arrangement or if that applicant is trying to claim that the claimed basic shape is a structure, such as a body, that has a shape that is of a preferred tooth/teeth position. It is noted that for examination purposes, the limitation is being interpreted as the claimed basic shape is a structure, such as a body, that has a shape that is of a preferred tooth/teeth position, however, the applicant should amend the claim to clarify what is being claimed.
With respect to claim 23, the claims “with at least partially buccal overlapping areas of individual teeth of a row of teeth of the set of teeth” is unclear as to what structure the applicant is trying to claim. It is noted that claim 23 depends from claims 21-22 in which the applicant has claimed an inner and outer wall, the outer wall is configured to cover the labial surface of the teeth. It is unclear if the claimed “at least partially buccal overlapping area” is functional, such as the basic has is configured to at least partially overlap buccal areas of the teeth or if the basic shape as a structure, related to the inner and outer walls, that is an overlapping area. It is further unclear if the claimed limitation is a structure, what is it is overlapping. It is noted that for examination purposes, the limitation is being interpreted as structure, such that adjacent tooth contours have overlapping portions, such as interproximal spaces when placed on the dental arch. It is noted that the claimed buccal overlapping areas would be a portion of the outer wall, however, the applicant should amend the claim to clarify what is being claimed.
With respect to claim 24, it is unclear how the tongue anchor is a protrusion which protrudes “from the inner wall” and then also “in the direction of the inner wall”. It is noted that for examination purposes, the limitation is being interpreted as the tongue anchor point protrudes from a portion of the inner wall towards another/different portion of the inner wall, however, the applicant should amend the claim to clarify what is being claimed.
With respect to claim 25, it is noted that the limitations of the bridging piece extending from the first or second leg “of the U-shape” is unclear. It is noted that the applicant has not claimed a specific “U-shaped” structure, but rather, as interpreted in detail above, a basic shape structure which has a u-shape. Therefore, it is noted that for examination purposes, the claimed limitations are being interpreted as the bridging piece extending from a first leg of the u-shaped basic shape and a second leg of the u-shaped basic structure, however, the applicant should amend the claim to clarify what is being claimed.
With respect to claim 27, it is unclear what structure that applicant is trying to claim with respect to the limitation of “the aligner”. It is noted that the applicant has claimed that the alinger includes the basic shape and the tongue anchor point (see claim 20). Therefore, the tongue anchor point is part of the alinger as claimed. It is noted that for examination purposes, the claimed area of the alinger is being interpreted as the claimed basic shape, however, the applicant should amend the claims to clarify what is being claimed.
Claim 29 recites the limitation "the protrusion" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the bridging piece" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
With respect to claim 34, the claimed “a different class of material” is unclear. It is unclear if the applicant is just trying to claim a material is different of if “a class” is a specific property or category that is different. It is noted that for examination purposes, the limitation is being interpreted as the claimed material different in any way, however, the applicant should amend the claim to clarify.
With respect to claim 36, the claimed “shield” is unclear as to how it is related to the claimed basic shape and/or tongue anchor. It is noted that for examination purposes, the claimed shield is being interpreted as part of the basic shape, however, the applicant should amend the claim to clarify what is being claimed.
In view of the above deficiencies, the claims were interpreted as best understood.
Claim Rejections - 35 USC § 102
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.
Claim(s) 20-23, 26, 28-29, 35, and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang (CN 109420289).
With respect to claim 20, Huang discloses, as best understood, an aligner 201/203 configured to align teeth of a set of teeth (see par. 49 of translation, specifically “the cavity has a geometry that repositions the dental arch from a first locality to a predetermined second layout”), wherein the aligner comprises a basic shape 201 specifying a preferred tooth position (see par, 49), wherein the basic shape has a U-shape delimiting an arched inner space complementary to the U-shape (see figs. 1a-1b); and a tongue anchor point 203 directed from the basic shape in a direction of the arched inner space (see fig. 1a), wherein the tongue anchor point is configured for positioning in an intended state close to a roof of a palate of an oral cavity of the set of teeth (see par. 52 of translation, such that component 203 is pressed against the palate).
With respect to claim 21 Huang further discloses wherein the basic shape, has an inner wall configured to lingually cover a row of teeth of the set of teeth (see fig. 1a, such that the inner wall is the wall on the inner portion of the arch shape, see annaoted figure below).
With respect to claim 22, Huang further discloses wherein the basic shape, has an outer wall configured to labially cover the row of teeth of the set of teeth (see fig. 1a, the outer wall of element 201 that is on the outer portion of the arch, see annotated figure below).
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With respect to claim 23, Huang further discloses, as best understood, wherein the basic shape has individual tooth contours with a predefined tooth position (see fig. 1, such that the overall shape has tooth contours, par. 49 of translation regarding the tooth position) and with at least partially buccal overlapping areas of individual teeth of a row of teeth of the set of teeth (such that the tooth cavities has interproximal areas as interpreted as the overlapping areas).
With respect to claim 26, Huang further discloses, wherein the tongue anchor point has a round body (see fig. 1a, such that the end portion is rounded where reference number 203 is pointing to).
With respect to claim 28, Huang further discloses, wherein the tongue anchor point has a geometric figure protruding at least partially in relation to a connection region of a protrusion of the tongue anchor point or in relation to a connection region of a bridging piece of the tongue anchor point (see annotated figures below).
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With respect to claim 29, Huang further discloses, wherein at least the protrusion or the bridging piece is arranged detachably in relation to the basic shape (see annotated figures above regarding the structure that is the claimed protrusion or bridging piece, see figs. 1b-1c, par. 47 regarding the limitation of being detachable).
With respect to claim 35, Huang further discloses wherein the tongue anchor point has movable elements which are moveable by a tongue (see figs. 1a-1c, such that all the elements of 203 including the rounded end, arm and connected sensors are moveable by the tongue, see pars. 52, 56 of translation).
With respect to claim 37, Huang further discloses sensors configured to determine physical or a chemical variable in saliva or in an oral cavity (see pars. 52, 56, such that the pressure sensor determined a physical variable).
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) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 109420289) as applied to claim 20 above, and further in view of Pumphrey, Jr. (2021/0275345).
Huang teaches the invention as substantially claimed and discussed above, however, does not specifically teach the tongue anchor point is a protrusion protruding which protrudes from the inner wall and the tongue anchor point is part of a bridging piece extending from a first leg of the u-shape to a second leg of the u-shape and bridges the arched inner space.
Pumphrey teaches an alinger 12/14 configured to align teeth of a set of teeth, wherein the alinger comprises a basic shape 12 specifying a preferred tooth position (pars. 64, 131), wherein the basic shape has a u-shape delimiting an arches inner space complementary to the u-shape, and a tongue anchor point 14 directed from the basic shape in a direction of the arches inner space (see figs. 1A, 2D, 2E).
With respect to claim 24, Pumphrey further teaches wherein the tongue anchor point 14 is a protrusion protruding which protrudes form the inner wall in the direction of the inner wall (see fig. 2D, such that the tongue anchor point protrudes from a portion of the inner wall towards a different portion of the inner wall).
With respect to claim 25, Pumphrey further teaches the tongue anchor point 14 is part of a bridging piece extending from a first leg of the u-shape to a second leg of the u-shape and bridges the arched inner space (see fig. 2D).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the tongue anchor point taught by Huang that extends from the basic shape into the arch with the tongue anchor point taught by Pumphrey that extends across the arch in order to position the tongue as designed. Further it is noted that it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the tongue anchor point taught by Huang that extends from the basic shape into the arch with the tongue anchor point taught by Pumphrey that extends across the arch as a matter of obvious design choice. It is noted that Pumphrey teaches the same arrangement of the tongue anchor point as taught by Huang (see fig. 2E of Pumphrey) and therefore teaches that the two different arrangements are known equivalents.
Claim(s) 27, 30, and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 109420289) as applied to claim 20 above, and further in view of Shah (2019/0091060).
Huang teaches the invention as substantially claimed and discussed above however, does not specifically teach the tongue anchor point has a different surface texture compared to areas of the alinger adjacent to the tongue anchor point, wherein the tongue anchor point has a different surface haptic compared to neighboring area of a bridging piece of the tongue anchor point or a protrusion of the tongue anchor point and opening are arranged in an area of the tongue anchor point.
Shah teaches a dental device 10 comprising a basic shape 17, the basic shape has a u-shape and a tongue anchor point 12/14 directed from the basic shape in a direction of the arches inner space (see fig. 1).
Shah further teaches with respect to claim 27, wherein the tongue anchor point has a different surface texture compared to areas of the device adjacent to the tongue anchor point (see par. 83, such that the pad 12 is textured, it is noted that only the pad is taught as textured as the rest of the device would not be textured).
Shah further teaches with respect to claim 30, wherein the tongue anchor point 12 has a different surface haptic compared to neighboring area of a bridging piece 14 of the tongue anchor point or a protrusion 14 of the tongue anchor point (par. 42, 83, 104, such that only the tongue anchor point is textured which would provide a different surface haptic compared to the portions 14).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the tongue anchor point taught by Huang with the different textures and holes taught by Shah in order to allow circulation of saliva and as a matter of obvious design choice in order to provide the desired training outcome for the tongue. It is noted that Shah teaches the tongue anchor point for the same purpose as Huang and that the surface can be smooth or textures (see par. 83 regarding the different surfaces and pars. 62, 77, 82).
Claim(s) 31-32 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 109420289) as applied to claim 20 above, and further in view of Gerber (3,187,746).
Huang teaches the invention as substantially claimed and discussed above, however, does not specifically teach the tongue anchor point has a chemical compound that is at least partially soluble in saliva, wherein the tongue anchor point has a coating applied to a carrier material, and a material of a different chemical composition is arranged in an area of the tongue anchor point or the tongue anchor point consist of a different class of material than areas neighboring a protrusion of the tongue anchor point or neighboring a bridging piece of the tongue anchor point.
Gerber teaches a dental device (entire device) comprising a basic shape 2/28 having a u-shape (see fig. 3), and a tongue anchor point 20/21/26 directed from the basic shape in a direction of the arched inner space (see figs. 3, 5), wherein the tongue anchor point is configured for positioning in an intended state close to a roof of a palate of an oral cavity of the set of teeth (see fig. 1).
With respect to claim 31, Gerber further teaches teach the tongue anchor point has a chemical compound that is at least partially soluble in saliva (such that portion 26 is soluble in saliva, col. 2, ll. 43-45).
With respect to claim 32, Gerber further teaches wherein the tongue anchor point has a coating 26 applied to a carrier material 20/21 (see fig. 5).
With respect to claim 34, Gerber further teaches a material of a different chemical composition is arranged in an area of the tongue anchor point (such that the material of element 26 is different than the material of element 20/21) or the tongue anchor point consist of a different class of material than areas neighboring a protrusion of the tongue anchor point or neighboring a bridging piece of the tongue anchor point (such that material 26 is of a different class than the protrusion/bridging element 20/21).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Huang with the different material taught by Gerber in order to provide a flavorant to encourage exercising of the mouth.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 109420289) as applied to claim 20 above, and further in view of Farrell (2020/0215384).
Huang teaches the invention as substantially claimed and discussed above, however, does not specifically teach the aligner has a shield segment configured to cover certain areas a row of teeth of the set of teeth, wherein the shield segment has at least one protrusion configured for lip stimulation on a side facing away from the teeth.
Farrell teaches a dental device comprising a basic shape having a u-shape delimiting an arched inner space (see figs. 1, 5), and a tongue anchor point 44 directed from the basic shape in a direction of the arched inner space, wherein the tongue anchor point is configured for positioning in an intended state close to a roof of a plate of an oral cavity of the set of teeth (pars. 142-144).
Farrell further teaches with respect to claim 36, wherein the alinger has a shield segment (outer wall 22) configured to cover certain areas a row of teeth of the set of teeth, wherein the shield segment has at least one protrusion 38 configured for lip stimulation on a side facing away form the teeth (see fig. 1, par. 83). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the alinger taught by Huang to include protrusions in order to inhibit overactivity of the mentalis muscle.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN 109420289) as applied to claim 20 above, and further in view of Choo (2024/0066291).
Huang teaches the invention as substantially claimed and discussed above, however, does not specifically teach the alinger further comprises actuators configured to generate and transmit stimulus signals.
Choo teaches a dental device comprising a basic shape 22/26 having a u-shape delimiting an arched inner space and a tongue anchor point 24/25 directed from the basic shape in a direction of the arched inner space.
With respect to claim 38, Choo further teaches actuators 32 configure to generate and transmit stimulus signals (see abstract, pars. 40, 43, 49). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Huang to include the actuators taught by Choo in order to activate contractions, stimulate salivation or other desired outcomes for the desired treatment outcome for the myofunctional therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 2/3/2026