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 .
Specification
The disclosure is objected to because of the following informalities: each figure must be described separately in the Brief Description of the Drawings, wherein Figures 1A-2B, 13-14 and 17A-17B are not. 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 15 and 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.
Regarding claim 15, the use of the term “optionally” in line 3 is indefinite. It is not understood if the term is used as an “and” term, or as an “and/or” choice. For examination purposes, the term will be interpreted as an “and/or” choice, in which the “or” option will be used.
Claim 18 recites the limitation " upper and lower blocks" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation " lower blocks" in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim Objections
Claims 21-23 are objected to because of the following informalities: The claims use the term “at least one stage” in line 1. Even when the Office understands that the term refers to the “sequential treatment stages” described in claim 1. It is suggested to maintain the same nomenclature across the claims. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: In line 1 indicated that it is received or generated “a digital skeletal representation”. The Office understands that said step refers to the step described in line 3 of claim 1. To avoid confusion, it is suggested to change the recitation to “the[a] digital skeletal representation”. Appropriate correction is required.
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.
Claims 1-7, 18-20 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nishimuta et al. (WO 2022256792 A1).
PNG
media_image1.png
396
584
media_image1.png
Greyscale
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Upper blocks)][AltContent: textbox (Upper appliance)][AltContent: arrow][AltContent: ][AltContent: textbox (Reft tooth engagement region)][AltContent: ][AltContent: textbox (Left tooth engagement region)]
PNG
media_image2.png
324
380
media_image2.png
Greyscale
[AltContent: textbox (Lower appliance)]
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Lower blocks)][AltContent: textbox (Reft tooth engagement region)][AltContent: ][AltContent: textbox (Left tooth engagement region)][AltContent: ][AltContent: arrow]
PNG
media_image3.png
296
370
media_image3.png
Greyscale
PNG
media_image4.png
328
378
media_image4.png
Greyscale
Regarding claim 1, Nishimuta et al. discloses a method of generating a skeletal treatment plan for multi-dimensional skeletal correction of a patient, including:
receiving or generating a digital skeletal representation of at least an upper jaw and a lower jaw of a patient (3110) (see Fig. 31 above and [0188] - [0189] and [0241] – “receiving a digital model of a patient’s teeth”);
determining, based on the digital representation, if the patient has at least one of: an oral skeletal condition or an airway condition (see [0050] – where method generates appliances for “treating class II malocclusions, class III malocclusions, and sleep apnea correction”, therefore, the digital representation of the patient can have any of an oral skeletal condition or an airway condition);
determining an amount of multi-dimensional skeletal correction between an initial skeletal arrangement and a target skeletal arrangement to treat the at least one condition (see [0185] – [0186], and [0241] – “generating a treatment plan based on the scan of a patent’s teeth to move the patient’s teeth from a first position towards a second position and to advance a mandible of the patient”);
determining, based on the determined amount of multi-dimensional skeletal correction to treat the at least one condition, a skeletal treatment plan including determining sequential treatment stages to provide the multi-dimensional skeletal correction (see [0185] – “the patient’s teeth can be progressively repositioned from an initial tooth arrangement to a target tooth arrangement by placing a series of incremental position adjustment appliances over the patient’s teeth. For example, the tooth repositioning system 2901 can include a first appliance 2903 A corresponding to an initial tooth arrangement, one or more intermediate appliances 2903B corresponding to one or more intermediate arrangements, and a final appliance 2903C corresponding to a target arrangement. A target tooth arrangement can be a planned final tooth arrangement selected for the patient’s teeth at the end of all planned orthodontic treatment”),
wherein the sequential treatment stages comprise a series of wearable pairs of an upper appliance and a lower appliance, that when sequentially worn by the patient, provide the multi-dimensional skeletal correction (3120) (see Fig. 31 above, [0044], [0048] – “a plurality of appliances can be sequentially placed for tooth movement at different incremental sequential stages of treatment and for mandibular relocation either in combination with tooth movement stages or separate stages for mandibular relocation”, [0202] – “an orthodontic treatment system comprising: a plurality of sets orthodontic aligners”); and
outputting instructions to fabricate the series of wearable pairs of upper appliances and lower appliances (3130) (see Fig. 31 above and [0241] – “generate one or more digital models of orthodontic aligners for carrying out one or more stages of the treatment plan; and output instructions for fabricating one or more orthodontic aligners based on the one or more digital models”).
Regarding claim 2, Nishimuta et al. discloses that the multi-dimensional skeletal correction includes an amount of lateral skeletal correction to an upper jaw, an amount of anterior-posterior (AP) skeletal correction of one or both of the patient's mandible or maxilla, and an amount of vertical skeletal correction between the mandible and the maxilla, or any combination of the lateral, skeletal and vertical skeletal corrections (see [0050] – including class II malocclusions, class III malocclusions, and sleep apnea correction; where the appliances includes occlusal blocks to promote mandibular relocation, such as by “promoting mandibular advancement, retraction, lateral correction, or a combination”).
Regarding claim 3, Nishimuta et al. discloses that the series of wearable pairs includes wearable pairs of a unitary upper application and a lower appliance (see Fig. 2A-2C above as an example and [0010], [0014-0016], [0058-0060]).
Regarding claim 4, Nishimuta et al. discloses that the at least one of the oral skeletal condition or the airway condition comprises obstructive sleep apnea (OSA), and/or one of a Class II bite or a Class III bite (see [0050]).
Regarding claim 5, Nishimuta et al. discloses that the outputting instructions to fabricate the series of wearable pairs of upper appliances and lower appliances includes fabricating the series of pairs of upper appliances and lower appliances ([0241] - “output instructions for fabricating one or more orthodontic aligners based on the one or more digital models”).
Regarding claim 6, Nishimuta et al. discloses that wherein fabricating includes using an additively manufacturing process to fabricate the upper appliances (see [0049], [0175] – “presently disclosed engagement structures and appliances are well suited for additive manufacturing. In some embodiments, the engagement structure and appliance can be directly manufactured with additive manufacturing as a single integrated component”).
Regarding claim 7, Nishimuta et al. discloses that wherein fabricating includes using a process that deposits an appliance material layer by layer and cures the appliance material. [0081] – “the first base 136a may be attached to a positive mold of a maxillary tooth through any suitable attachment structure or method, such as deposition manufacturing of the positive mold and first base together”).
[AltContent: ][AltContent: textbox (Plurality of cavities)][AltContent: textbox (Blocks)][AltContent: arrow][AltContent: arrow]
PNG
media_image5.png
636
320
media_image5.png
Greyscale
Regarding claim 18, Nishimuta et al. discloses that over the course of the treatment time for the pair, the interface between the upper and lower blocks further provides vertical skeletal expansion between the maxilla and the mandible (see Fig. 1 above and [0055]).
Regarding claim 19, Nishimuta et al. discloses that the upper and lower blocks each include occlusal blocks (see Fig. 1 above and [0055] and [0058] – where the block is located on the occlusal surface of the appliance).
Regarding claim 20, Nishimuta et al. discloses that the lower appliance (100b) includes a shell with a plurality of cavities each configured to receive therein a lower jaw tooth, wherein the lower blocks extend from an occlusal of the lower appliance (see Fig. 1 above, [0054] and [0058]).
Regarding claim 23, Nishimuta et al. discloses that the treatment plan includes at least stage with AP skeletal correction without lateral skeletal correction (see [0050] – appliances for class II malocclusions and class III malocclusions correction).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimuta et al. (WO 2022256792 A1) as applied to claim 1 above, and further in view of Greenberg (US 20120191421 A1).
Regarding claim 8, Nishimuta discloses the claimed invention substantially as claimed, as set forth above for claim 1, where Nishimuta discloses that the generation of the digital skeletal representation “can include surface topography data for the patient's intraoral cavity (including teeth, gingival tissues, etc.” (see [0189]).
Greenberg teaches an oral template for integrated CT and optical images for dental applications including orthodontic treatment of a patient with orthodontic aligners, where a scan is generated including accurate representation of tooth anatomy integrated with root anatomy and bony anatomy, in which it is generated a “3D model is put through a simulation process of tooth movement to simulate the orthodontic tooth movement to final tooth positions with knowledge of the tooth crown shape and orientation as well as the tooth root anatomy and relationship to other tooth roots and adjacent bony and anatomic anatomy such as nerves and sinus cavities” (see [0038]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the step of receiving or generating a digital skeletal representation of at least an upper jaw and a lower jaw of Nishimuta, with the generation and used of scanned images including tooth anatomy integrated with root anatomy and bony anatomy of Greenberg, in order to understands the movement of the teeth in the oral cavity and if said movement impact nerves and the airways at the sinus cavities.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimuta et al. (WO 2022256792 A1) as applied to claim 1 above, and further in view of Guo et al. (WO 2018153219 A1).
Regarding claim 9-10, Nishimuta discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Nishimuta discloses “directly scanning the intraoral cavity using a suitable scanning device (e.g., a handheld scanner, desktop scanner, etc.)” for receiving or generating the digital skeletal representation of at least the upper jaw and the lower jaw of a patient (see [0189]), where the “scanner 3220 includes any means for obtaining a digital representation (e.g., images, surface topography data, etc.)” (see [0196]).
However, Nishimuta does not disclose that it is used cone- beam computed tomography (CBCT) scan (for claim 9); and receiving or generating the digital skeletal representation includes receiving or generating the digital representation from cone-beam computed tomography (CBCT) (for claim 10).
Guo et al. teaches a dental appliance for correcting malocclusion, that uses direct scanning of the patient’s dentition to obtain its original dental layout using tomography (CAT scan), digital tomography (CT), cone beam CT (CBCT), nuclear magnetic resonance imaging (MRI), intraoral optical scanning, and the like (page 6, lines 21-24).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the step of receiving or generating the digital skeletal representation of Nishimuta, with the cone beam CT (CBCT), as an alternative scanning means to obtain the digital image of the patient. Furthermore, it is well known in the art that CBCT provides better detailed images with less radiation than traditional CT scans.
Claims 11-17 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimuta et al. (WO 2022256792 A1) as applied to claim 1 above, and further in view of Kimura et al. (US 20160081769 A1).
Regarding claim 11 and 12, Nishimuta discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Nishimuta discloses that wherein, for each of the pairs, the upper appliance (100a) includes a left tooth engagement region, a right tooth engagement region (see Fig. 2A above), where auxiliary components can be added such as palatal expanders and palatal bars in combination with the upper appliance (see [0186]), and an upper block (110a) extending from the left or right tooth engagement region (see Fig. 2A above), and the lower appliance (100b) is configured to be removably worn over teeth in the patient's lower jaw (see Fig. 2B above), the lower appliance (100b) including a lower block (110b), and over the course of a treatment time for the pair, the upper appliance (100a) is sized and shaped to cause the interface between the upper and lower blocks provides anterior-posterior (AP) skeletal correction between a mandible and a maxilla of the patient (see Fig. 2A-2C above and [0050], [0052] and [0055] – the appliances correct class 2 and class 3 malocclusion in a patient) (for claim 11); and the interface between the upper and lower blocks (110a, 110b) provides AP skeletal correction between the mandible and the maxilla (see Fig. 2A-2C above, [0050], [0052] and [0055] – the appliances correct class 2 and class 3 malocclusion in a patient; and [0186] – where an auxiliary components can be added such as palatal expanders and palatal bars in conjunction with an orthodontic appliance) (for claim 12).
However, Nishimuta does not disclose that the upper appliance includes a palatal region between the left tooth engagement region and the right tooth engagement region (for claim 11); and that the upper appliance (100a) is sized and shaped to cause lateral skeletal expansion of the upper jaw (for claim 12).
[AltContent: arrow][AltContent: textbox (Palatal region)][AltContent: arrow][AltContent: textbox (Left tooth engagement region)][AltContent: arrow][AltContent: textbox (Right tooth engagement region)]
PNG
media_image6.png
418
536
media_image6.png
Greyscale
Kimura et al. teaches an upper dental appliance including a removable shell that includes between the left tooth engagement region and the right tooth engagement region a palatal region, in which the size and shape of the upper appliance is configured to cause lateral skeletal expansion of the upper jaw of the palatal plates (see, Fig. 9 above, Abstract, [0042]-[0046, [0049]-[0050]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the upper appliance of Nishimuta, with the palatal region between the left tooth engagement region and the right tooth engagement region of Kumura, in order to cause lateral skeletal expansion of the upper jaw by the separation of the palatal plates.
Regarding claim 13, Nishimuta/Kumura discloses the claimed invention substantially as claimed, as set forth above for claim 11, and where Nishimuta et al. discloses that the AP skeletal correction between the mandible and the maxilla includes anterior movement of the mandible relative to the maxilla (see [0050] – where it includes class 3 malocclusion treatment).
Regarding claim 14, Nishimuta/Kumura discloses the claimed invention substantially as claimed, as set forth above for claim 13, and where Nishimuta et al. discloses the anterior movement of the mandible treat a Class II bite (see [0186] – where auxiliary components can be added such as palatal expanders and palatal bars, and [0050] – where it includes class 2 malocclusion treatment; therefore, the appliance can expand laterally treat Class II malocclusion).
However, Nishimuta does not disclose the inclusion of lateral skeletal expansion.
Kimura et al. teaches that the upper dental appliance a palatal region, in which is configured to cause lateral skeletal expansion of the upper jaw of the palatal plates (see, Fig. 9 above, Abstract, [0042]-[0046, [0049]-[0050]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the upper appliance of Nishimuta, with the palatal region of Kumura, in order to cause lateral skeletal expansion of the upper jaw by the separation of the palatal plates.
Regarding claim 15, Nishimuta/Kumura discloses the claimed invention substantially as claimed, as set forth above for claim 11, and where Nishimuta et al. discloses that wherein AP skeletal correction between the mandible and the maxilla includes posterior movement of the mandible relative to the maxilla, to treat a Class III bite (see [0050] – where it includes Class 3 malocclusion treatment).
Regarding claim 16, Nishimuta/Kumura discloses the claimed invention substantially as claimed, as set forth above for claim 11, and where Nishimuta et al. discloses that the AP skeletal correction between the mandible and the maxilla includes anterior movement of the maxilla relative to the mandible (see [0050] – includes Class 3 malocclusion treatment).
Regarding claim 17, Nishimuta/Kumura discloses the claimed invention substantially as claimed, as set forth above for claim 11, and where Nishimuta et al. discloses that the AP skeletal correction between the mandible and the maxilla includes posterior movement of the maxilla relative to the mandible (see [0050] – includes Class 2 malocclusion treatment).
Regarding claim 21, Nishimuta discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Nishimuta discloses that the treatment plan includes at least one stage (see Fig. 31 above, [0044], [0048] – “a plurality of appliances can be sequentially placed for tooth movement at different incremental sequential stages of treatment and for mandibular relocation either in combination with tooth movement stages or separate stages for mandibular relocation”, [0202] – “an orthodontic treatment system comprising: a plurality of sets orthodontic aligners”).
However, Nishimuta does not disclose treatment plan includes at least one stage with simultaneous lateral skeletal correction of the upper jaw and AP skeletal correction.
Kimura et al. teaches an upper dental appliance including a removable shell that includes between the left tooth engagement region and the right tooth engagement region a palatal region, in which the size and shape of the upper appliance is configured to cause lateral skeletal expansion of the upper jaw of the palatal plates (see, Fig. 9 above, Abstract, [0042]-[0046, [0049]-[0050]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the upper appliance of Nishimuta, with the palatal region between the left tooth engagement region and the right tooth engagement region of Kimura, in order to cause lateral skeletal expansion of the upper jaw by the separation of the palatal plates.
Regarding claim 22, Nishimuta discloses the claimed invention substantially as claimed, as set forth above for claim 1, and where Nishimuta.
However, Nishimuta does not disclose that the treatment plan includes at least one stage with lateral skeletal correction without AP skeletal correction.
Kimura et al. teaches that there are some situations where the patient’s arch is too narrow, causing overcrowding of the patient’s teeth, impacted teeth, speech difficulty, breathing issues, etc. In such situations an arch expansion treatment is performed in an early stage of the plan to provide more room for the teeth to be arranged (see [0031]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Nishimuta, with the at least one stage in the early stage of the treatment plant with lateral skeletal correction of Kimura, in order when the arch of the patient’s teeth is too narrow to initially move the teeth in anterior-posterior direction, having lateral correction provide more room in the arch for the teeth, in this way they can be arranged in posterior stages of the treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIRAYDA ARLENE APONTE whose telephone number is (571)270-1933. The examiner can normally be reached M-F 8-5.
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, Eric Rosen can be reached at 571-270-7855. 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.
/MIRAYDA A APONTE/Examiner, Art Unit 3772
/NICHOLAS D LUCCHESI/Primary Examiner, Art Unit 3772
Prosecution Insights