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 .
Priority
Acknowledgment is made of applicant’s claim for domestic priority to U.S. Provisional Patent Application No. 63/591,401.
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.
Claim(s) 8 and 15 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.
Claim 8 recites “less precise” and “more broad”; wherein the terms “less” and “more” are unclear as to what they are in reference to.
Claim 15 recites the limitation "the first manifold" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim nor claim 13 upon which it is dependent on. For continued examination, the examiner interprets claim 15 to be dependent on claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 19 – 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruedisueli et al. (US 2022/0027526 A1).
Regarding claim 19, Ruedisueli et al. discloses a system (see Fig. 2B), comprising: a processor (262 Fig. 2B; paragraph 0054)) configured to: receive a treatment plan associated with a user (paragraph 0059); design a plurality of oral inserts based on the treatment plan associated with the user, wherein the plurality of oral inserts include a corresponding plurality of fluid nozzles, wherein a corresponding location of one, some, or all of a first plurality of fluid nozzles associated with a first oral insert of the plurality of oral inserts is different than a corresponding location of one, some, or all of a second plurality of fluid nozzles associated with a second oral insert of the plurality of oral inserts; and generate the plurality of oral inserts (paragraphs 0035, 0039, 0071, 0073, 0078, and 0094); and a memory (264 Fig. 2B) coupled to the processor and configured to provide the processor with instructions (paragraph 0055; the memory (264) may store instructions to cause the processor (262) to execute modules, processes, and/or functions associated with the computing system (250), such as identification, generation, modification, optimization, storage, output, analysis, notification, communication, authentication, user settings, combinations thereof, and the like).
Regarding claim 20, Ruedisueli et al. discloses a computer program product embodied in a non-transitory computer readable medium and comprising computer instructions for (paragraph 0056 – 0058; the disclosed invention may be performed by software (a computer program)): receiving a treatment plan associated with a user; designing a plurality of oral inserts based on the treatment plan associated with the user, wherein the plurality of oral inserts include a corresponding plurality of fluid nozzles, wherein a corresponding location of one, some, or all of a first plurality of fluid nozzles associated with a first oral insert of the plurality of oral inserts is different than a corresponding location of one, some, or all of a second plurality of fluid nozzles associated with a second oral insert of the plurality of oral inserts; and generating the plurality of oral inserts (paragraphs 0035, 0039, 0071, 0073, 0078, and 0094; these process as disclosed may be performed by software ( a computer program)).
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 – 8 and 10 – 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruedisueli et al. (US 2022/0027526 A1) in view of Zegarelli et al. (US 2022/0395361 A1).
Regarding claim 1, Ruedisueli et al. discloses a method comprising: receiving a treatment plan associated with a user (paragraph 0086; the scanned patient oral data or oral scan data or optical anatomy data or a combined plurality of oral scan data modalities can all be components of a treatment plan that can be incorporated into the disclosed method – scan data represents a treatment plan since it shows the teeth and tooth surfaces that needs to be treated/cleaned); designing a plurality of oral inserts based on the treatment plan associated with the user (paragraph 0045, 0070, and 0086; oral inserts are generated based on the oral data associated with the user), wherein the plurality of oral inserts include a corresponding plurality of fluid nozzles (340 Figs. 3A – D; paragraphs 0008 and 0039), wherein a corresponding location of one, some, or all of a first plurality of fluid nozzles associated with a first oral insert (top oral insert, annotated Fig. 3D) of the plurality of oral inserts is different than a corresponding location of one, some, or all of a second plurality of fluid nozzles associated with a second oral insert (bottom oral insert, annotated Fig. 3D) of the plurality of oral inserts (see annotated Fig. 3D below; paragraphs 0071, 0073 and 0078; combination of the top and bottom oral inserts); and generating the plurality of oral inserts (paragraph 0035
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and 0045).
Regarding claim 1, Ruedisueli et al. did not explicitly disclose the method comprising: receiving a treatment plan associated with a user. The method as disclosed by Ruedisueli et al. describes the steps of generating a model of an oral insert that is configured to provide personal irrigation and cleaning of oral tissue/teeth (paragraphs 0011 and 0036). The claimed invention of application 18/908,607 is directed towards the generation of a plurality of oral inserts adapted to a treatment plan to improve cleaning of the teeth and/or gums (Paragraphs 0015 -0016) while implanting the treatment plan which could include the use of aligners or braces or wires (which can include aligners or devices for moving the teeth). However, Zegarelli et al. teaches an analogous method of making and using an oral appliance, comprising: receiving a treatment plan associated with a user (paragraph 0091; the oral appliances are based on treatment plans as the oral appliances can be provided with different treatment plans). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Ruedisueli et al. to be adapted to a treatment plan for a user, as taught by Zegarelli et al. One of ordinary skill in the art would have been motivated to make this modification in order to create a method for creating adaptable oral inserts that can be adapted to treatment plans to promote oral hygiene without compromising or stopping adherence to the treatment plan, as suggested by Zegarelli et al.
Regarding claim 2, Ruedisueli et al./ Zegarelli et al discloses the claimed invention substantially as set forth in claim 1 above including the designing of personalized oral inserts. In the case of Ruedisueli et al., the oral inserts are for the purpose of oral irrigation. Ruedisueli et al. is silent regarding claim 2 wherein the treatment plan associated with the user indicates at least one of the following: a series of steps for one, some, or all of the user’s teeth; and a corresponding amount of movement associated with one, some, or all of the user’s teeth.
Zegarelli et al further teaches an analogous method wherein the treatment plan associated with the user indicates at least one of the following: a series of steps for one, some, or all of the user’s teeth; and a corresponding amount of movement associated with one, some, or all of the user’s teeth (Paragraph 0092; the oral inserts generated can be used to adjunctively assist orthodontic aligners which are part of a treatment plan, and the orthodontic aligners are for incremented/corrective teeth movement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ruedisueli et al. to include a treatment plan comprising a series of steps for one, some or all the user’s teeth; and a corresponding amount of movement associated with one, some or all of the user’s teeth, as taught by Zegarelli et al. One of ordinary skill in the art would have been motivated to make this modification in order to provide personalized inserts for a patient’s teeth as they move during treatment. As set forth by Zegarelli et al, the movement of a patient’s teeth during treatment is known by those of ordinary skill in the art. One of ordinary skill in the art would be motivated to make this modification in order to create a method for oral appliance that is adaptable to the varying teeth movements associated with a user’s treatment plan.
Regarding claim 3, Ruedisueli et al./ Zegarelli et al discloses the claimed invention substantially as set forth in claim 2 above. Zegarelli et al further teaches the method wherein the corresponding amount of movement associated with the one, some, or all of the user’s teeth includes linear movement, angular movement, rotational movement, a removal of teeth, and/or a change in number of teeth (Paragraph 0092; orthodontic aligner appliances of the treatment plan are designed to move teeth. While the type of movement is not explicitly disclosed, it is known in the field that orthodontic aligners would cause rotational, translational, or intrusion movements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Ruedisueli et al./ Zegarelli et al. to include a step wherein the corresponding amount of movement associated with the user’s teeth includes linear movement, angular movement, rotational movement, a removal of teeth, and/or change in number of teeth, as taught by Wen. One of ordinary skill in the art would have been motivated to make this modification using the rational set forth in claim 2 above.
Regarding claim 4, Ruedisueli et al./ Zegarelli et al discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein the first oral insert of the plurality of oral inserts is designed for a subset of a plurality of steps of the treatment plan associated with the user (paragraph 0078; top oral insert (top tray) designed for the maxillary teeth is a subset of a plurality of steps of the treatment plan that potentially comprise both the maxillary and the mandibular teeth).
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Regarding claim 5, Ruedisueli et al. discloses the claimed invention substantially as set forth in claim 4 above. Ruedisueli et al. further discloses the method wherein the first oral insert of the plurality of oral inserts is designed for a flexible keying feature (352 Figs. 3A – B and annotated 3D; paragraph 0076; the top oral insert (first oral insert) is designed in such a configuration to accommodate a keying feature, 352).
Ruedisueli et al. is silent regarding claim 5 wherein the subset of the plurality of steps of the treatment plan associated with the user comprises a set of movement steps associated with one, some, or all of the user’s teeth.
Zegarelli et al. teaches an analogous method wherein the subset of the plurality of steps of the treatment plan associated with the user comprises a set of movement steps associated with one, some, or all of the user’s teeth (paragraph 0092; “In some embodiments, the present oral appliance can be utilized to adjunctively assist those orthodontic aligner appliances which are designed to move teeth and to treat the teeth and/or soft tissue area of the oral cavity with medicament disposed at discrete regions of the oral appliance without affecting the tooth movements those orthodontic aligner appliances effect. Therefore, a plurality of oral appliances can be configured to fit the inflamed soft tissues in the different positions as the teeth are moved”. Orthodontic aligner appliances of the treatment plan are designed to move teeth. While the movement is not explicitly disclosed as being a set of movement steps, it is known in the field that orthodontic aligners causes incremental movement steps for correcting malocclusion or for orthodontic treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ruedisueli et al. to include a treatment plan comprising a subset of the plurality of steps of the treatment plan associated with the user comprises a set of movement steps associated with one, some, or all of the user’s teeth (paragraph 0092; the tooth/teeth movement effected by the orthodontic aligners associated with treatment plan), as taught by Zegarelli et al. One of ordinary skill in the art would have been motivated to make this modification as set forth in the motivation in claim 2 above.
Regarding claim 6, Ruedisueli et al./ Zegarelli et al. discloses the claimed invention substantially as set forth in claim 5 above. Ruedisueli et al. further discloses the method wherein the flexible keying feature comprises at least one of the following: a keying tray (350 Fig. 3A); a compliant keying material; and a keying absence (paragraph 0076; one or more alignment features (352) may be located within the tray (350) to help seat the teeth within the tray (350)).
Regarding claim 7, Ruedisueli et al. discloses the claimed invention substantially as set forth in claim 4 above. Ruedisueli et al. further discloses the method wherein the first oral insert of the plurality of oral inserts is designed for a flexible fluid nozzle (340 Figs. 3A and annotated Fig. 3D; paragraph 0075; note that flexible fluid nozzle is not positively claimed). Ruedisueli et al. is silent regarding claim 7 wherein the subset of the plurality of steps of the treatment plan associated with the user comprises a set of movement steps associated with one, some, or all of the user’s teeth.
Zegarelli et al teaches an analogous method wherein the subset of the plurality of steps of the treatment plan associated with the user comprises a set of movement steps associated with one, some, or all of the user’s teeth (paragraph 0092; “In some embodiments, the present oral appliance can be utilized to adjunctively assist those orthodontic aligner appliances which are designed to move teeth and to treat the teeth and/or soft tissue area of the oral cavity with medicament disposed at discrete regions of the oral appliance without affecting the tooth movements those orthodontic aligner appliances effect. Therefore, a plurality of oral appliances can be configured to fit the inflamed soft tissues in the different positions as the teeth are moved”. Orthodontic aligner appliances of the treatment plan are designed to move teeth. While the movement is not explicitly disclosed as being a set of movement steps, it is known in the field that orthodontic aligners causes incremental movement steps for correcting malocclusion or for orthodontic treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ruedisueli et al. to include a treatment plan comprising a subset of the plurality of steps of the treatment plan associated with the user comprises a set of movement steps associated with one, some, or all of the user’s teeth (paragraph 0092; the tooth/teeth movement effected by the orthodontic aligners associated with treatment plan), as taught by Zegarelli et al. One of ordinary skill in the art would have been motivated to make this modification as set forth in the motivation in claim 2 above.
Regarding claim 8, Ruedisueli et al./Zegarelli et al. discloses the claimed invention substantially as set forth in claim 7 above. Ruedisueli et al. further discloses the method wherein the flexible fluid nozzle comprises at least one of the following: a less precise nozzle shape; a more broad nozzle spray (paragraphs 0073 and 0100; the nozzle shape can be modified as desired to control one or more of a pressure, shape, and direction of fluid flow); a nozzle absence in an event that the subset of the plurality of steps of the treatment plan associated with the user comprises a tooth removal; and a nozzle (340 Figs. 3A – D) addition in an event that the subset of the plurality of steps of the treatment plan associated with the user comprises a tooth emergence (see element 340 which is a nozzle addition which may be incorporated to the treatment plan; note that flexible fluid nozzle is not positively claimed and that device is only claimed as designed for (use) with one).
Regarding claim 10, Ruedisueli et al./ Zegarelli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein the treatment plan associated with the user indicates a rinse adjustment comprising at least one of the following: a treatment rinse solution, an after-treatment rinse solution, a rinse duration setting, a rinse intensity setting, and a rinse pulsation setting (paragraph 0048 and 0072; the manifold switch (234) allows for the control of fluid flow rates which the examiner interprets to be a rinse intensity setting).
Regarding claim 11, Ruedisueli et al./ Zegarelli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein the first oral insert of the plurality of oral inserts is designed for a sub-step of a plurality of steps of the treatment plan associated with the user (paragraph 0078; top oral insert (top tray) designed for the dental treatment of the maxillary teeth which is a sub-step of a plurality of steps of the treatment plan that potentially comprise both the treatments of the maxillary and the mandibular teeth).
Regarding claim 12, Ruedisueli et al./ Zegarelli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein at least one of the corresponding plurality of fluid nozzles is at least one of the following: directed downwards towards a gingival margin, an interproximal space between the user’s teeth, an incisal edge, or contours of occlusal, facial, lingual, mesial, and distal surfaces of the user’s teeth; directed upwards towards a gingival margin, an interproximal space between the user’s teeth, an incisal edge, or contours of occlusal, facial, lingual, mesial, and distal surfaces of the user’s teeth; directed towards a gingival margin, an interproximal space between the user’s teeth, an incisal edge, or contours of occlusal, facial, lingual, mesial, and distal surfaces of the user’s teeth at a polar angle between 0° and 180°; and directed towards a gingival margin, an interproximal space between the user’s teeth, an incisal edge, or contours of occlusal, facial, lingual, mesial, and distal surfaces of the user’s teeth at an azimuthal angle between 0° and 180° (paragraphs 0096 – 0098; describes the spatial relationships (an aspect of an object’s geometry) of the plurality of fluid nozzles can be based on the patient’s oral geometry which was described in paragraph 0096 comprises the interproximal, facial interproximal, facial side, lingual interproximal point. Thus, the patient’s oral geometries are factors in determining the features and direction of the fluid nozzle. Fig. 9 illustrates a fluid nozzle (900) directed towards the contours of occlusion or distal or medial surfaces of a tooth (910) Fig. 13 illustrates fluid nozzles (1330) directed towards the interproximal space between the teeth).
Regarding claim 13, Ruedisueli et al./ Zegarelli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein at least one of the corresponding plurality of fluid nozzles is at least one of the following: directed downwards towards a bracket, wire, or attachment associated with a tooth of the user; directed upwards towards a bracket, wire, or attachment associated with a tooth of the user; directed towards a bracket, wire, or attachment associated with the user at a polar angle between 0° and 180°; and directed towards a bracket, wire, or attachment associated with the user at an azimuthal polar angle between 0° and 180° (paragraphs 0096 – 0098; Figs. 9 and 13; the fluid nozzles as disclosed can be directed downwards or upwards as desired by the user as best illustrated in Figs. 9 and 13. Thus, if a user have a wire or bracket or an attachment associated with a tooth, the fluid nozzle can be directed to the same since these additions would be affixed or on the teeth of the user).
Regarding claim 14, Ruedisueli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein he first oral insert (see annotated Fig. 3D) of the plurality of oral inserts includes a first manifold (see annotated Fig. 3D) having a first number of fluid nozzles (see annotated Fig. 3D) and the second oral insert of the plurality of oral inserts includes the first manifold (see annotated Fig. 3D) having a second number of fluid nozzles (see annotated Fig. 3D), wherein the first number of fluid nozzles is different than the second number of fluid nozzles (see annotated Fig. 3D; first
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number of fluid nozzles is different than the second number of fluid nozzles).
Regarding claim 15, Ruedisueli et al./ Zegarelli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein the first manifold (1320 Fig. 13) of the second oral insert includes one or more flow balancing ports (1328 Fig. 13; paragraph 0112).
Regarding claim 16, Ruedisueli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein a shape associated with the corresponding plurality of fluid nozzles (340 Fig. 3D) is the same (see Fig. 3D element 340 is depicted to have the same shape; paragraph 0096 – 0106; the shape and geometry of the fluid nozzles can be configured as desired).
Regarding claim 17, Ruedisueli et al./ Zegarelli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein a shape associated with at least one of the corresponding plurality of fluid nozzles is different than other fluid nozzles of the corresponding plurality of fluid nozzles (Paragraph 0089; the geometry of the fluid nozzles is based on the oral scan data of the jaw thus, it is interpreted by the examiner that the geometry fluid nozzles associated with the oral inserts for the mandibular would be different from the geometry of the fluid nozzles associated with the oral inserts for the maxilla given that the anatomy of the upper jaw is different from that of the lower jaw).
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Regarding claim 18, Ruedisueli et al./ Zegarelli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al. further discloses the method wherein a location of a first set of one or more keying features (352 Figs. 3A – C and annotated Fig. 3D) associated with the first oral insert (see annotated Fig. 3D) is different than at least one of one or more other oral inserts of the plurality of oral inserts (location of element 352 which is associated with the top oral insert is different from the bottom oral insert).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ruedisueli et al. (US 2022/0027526 A1) in view of Zegarelli et al. (US 2022/0395361 A1) and further in view Wen (US 2017/0100214 A1).
Regarding claim 9, Ruedisueli et al./Zegarelli et al. discloses the claimed invention substantially as set forth in claim 1 above. Ruedisueli et al./Zegarelli et al. is silent regarding the method wherein the treatment plan associated with the user indicates a corresponding amount of movement associated with relative alignment between an upper arch of the user and a lower arch of the user.
Wen teaches an analogous method wherein the treatment plan associated with the user indicates a corresponding amount of movement associated with relative alignment between an upper arch of the user and a lower arch of the user (paragraphs 0141 – 0143; describes a process that entails calculation of the lower arch and upper arch relationship which can include alignment and effective opening and closing process of the arch model. Once the alignment/relationship of the arch has been acquired, one or more treatments including movement of the user’s teeth, may be created and incorporated in the treatment plan. Furthermore, it is foundational knowledge in the field that any dental correction is dependent on the ideal alignment of the upper and lower arches in order to achieve perfect occlusion).
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Ruedisueli et al./Zegarelli et al. to include a step wherein the treatment plan associated with the user indicates a corresponding amount of movement associated with relative alignment between an upper arch of the user and a lower arch of the user, as taught by Wen. One of ordinary skill in the art would have been motivated to make this modification in order to create a method for generating oral inserts that accounts for all possible teeth movements relative to the alignment between an upper arch and a lower arch of the user. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHIEMERIE C AZUBUOGU whose telephone number is (571)272-0664. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:00PM.
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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.
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/C.A./ Patent Examiner, Art Unit 3772 /ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772