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 .
DETAILED ACTION
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites the limitation “wherein a first of the plurality of stages are associated”, but should read “wherein a first of the plurality of stage is associated”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with the “2019 Revised Patent Subject Matter Eligibility Guidance,” issued January 7, 2019 the pending claims are analyzed as follows —
Step 1 - In regard to claims 1-4 and 6-21 are directed to a process of generating data of an orthodontic treatment plan including, designing digital bite adjustment structures and adjusting the structures for a second stage of treatment, and outputting digital models which is intended to operate on a generic computing device. The various dependent claims all add only additional purely digital information to the locations of parts of the digital model. The method is within the 35 U.S.C. 101 statutory category of a “process” (MPEP 2106.03), but falls into the judicial exception (MPEP 2106.04).
Step 2A —In regard to claims 1-4 and 6-21, the claimed inventions are directed to an abstract idea(MPEP 2106.04(a)) without reciting additional elements that amount to significantly more than the judicial exception (MPEP 2106.05). The claimed inventions are directed to a mental process — concepts that are capable of being performed in the human mind or with paper and pencil— including observations, evaluations and judgements. More particularly the generating of treatment plans and digital models that have some desired digital elements and digital parts and outputting/providing of those digital models is capable of being done mentally (a dentist views a patient’s dentition envisioning a 3D image of the appliances with particular shapes and the structures being positioned for different treatment appliances that would output as a mental model to be eventually used to made a physical appliance).
It is further noted that orthodontists have long practiced their trade/art of determining mentally what prosthetic restorations and treatment plans are needed for a patient and how they are to be shaped and designed—well before the advent of computers — and are most certainly capable of envisioning and mentally determining the treatment plans stages and appliances along with shapes and arrangements of dental restorations necessary to accomplish a desired model of jaws to be used in fabrication of aligners.
Step 2B — In regard to claims 1-4 and 6-21, the claimed method steps are capable of being performed mentally and represent nothing more than concepts related to performing mental modeling steps which fall within the judicial exception. Implicit in the claimed invention is the intended use of a computing or data processing device, however, there is no disclosure in the written description that the processing unit is anything more than a generic component, nor is there any disclosure that the method of modeling and outputting models improves the manner in which the processing unit operates. The mere recitation in the claims of the intention to operate a generic conventional processing unit that is used in a conventional manner to perform conventional computer functions that are well understood and routine does not amount to "significantly more" than the judicial exception. The claims do not go beyond generating and adjusting data, and “providing” based on mathematical algorithms with a standard generic computer.
The analysis of data in a particular field and the stating those functions in general terms, without limiting them to technical means for performing the functions is an abstract idea and does not meet the requirements of 35 U.S.C. 101. The claims do not require that the method be implemented by a particular machine and they do not require that the method particularly transform a particular article. The claims set forth instructions of analyzing information of a specific content and are not directed to any particularly asserted inventive technology for performing those functions. Nothing in the claims or specification requires anything more than a conventional prior art computer for analyzing numbers according to a mathematical algorithm. The claimed method thus falls with the judicial exception to patent eligible subject matter of an abstract idea without significantly more. See Elec. Power Grp., LLC v. Alstom S.A., 119 USPQ2d 1739 (Fed. Cir. 2016) for further guidance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8, 10-18, 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (WO 2012140021) in view of Phan et al. (US 6,572,372).
Regarding claims 1-5 and 12-15, Barthe discloses a method for use in orthodontic treatment (title and abstract disclosing digital method) with step of:
generating an orthodontic treatment plan comprising a plurality of stages wherein a first of the plurality of stages is associated with providing disocclusion of arches of a patient to (page 43 lines 17-27 disclosing generating of a treatment plan based on a malocclusion with a number of treatment steps/stages, page 106 lines 17-26 disclosing a stage made with a bar to prevent opposing jaws form closing together and thus providing a disocclusion), for the first of the plurality of stages of the orthodontic treatment plan providing disocclusion:
positioning a plurality of digital bite adjustment structures at on occlusal surface so that the structures extend beyond the occlusal plane of molar teeth (page 22 lines 23-26 disclosing the DBAS as a occlusion guiding surface that is arranged on a lingual side of the teeth) on a corresponding plurality of digital tooth receiving cavities of a digital model of an appliance for a first jaw at a first stage of a treatment plan (Fig. 28 digital bite adjustment structure element 1806 solid line occlusal surface paced on the shell 2800 with digital tooth receiving cavities, Fig. 30 DBAS element 3000/3002, page 1 lines 3-5 disclosing the appliance and its part being virtual and thus digital);
designing the digital bite adjustment structures to extend from a lingual surface of the corresponding plurality of digital tooth receiving cavities (Fig. 26b-c showing the digital bite adjustment structure 2610 is on the posterior/molar teeth) configured to provide posterior disocclusion (page 106 lines 17-26 the digital structure on the molars would prevent the jaws from touching by being between the molar teeth and thus provide posterior disocclusion)
and have a first surface shape and location specific to the first stage of a treatment plan to provide a disocclusion between the first jaw and the second jaw (page 22 lines 23-26 disclosing the first occlusion guiding surface being on the lingual surface and page 11 lines 11-17 disclosing that the first occlusion guiding surface is configured to contact and guide the teeth between the upper and lower jaws thus causing a disocclusion from a patient’s natural occlusion), the first surface shape being an external surface shape designed to interface with teeth of a second jaw (Figs. 28 and 30 showing a first external surface designed to interface with teeth of second jaw, page 43 lines 18-27 disclosing the method being applied to a series of successive tooth arrangement and the use of successive stages of appliances, page 37 lines 20-21 disclosing the iterative manner of correcting occlusion in stages, page 38 lines 1-3 disclosing iterative appliances) and ;
adjusting the digital bite adjustment structures on the corresponding plurality of posterior digital teeth of the digital model of the first jaw at a second stage of the treatment plan according to changes to the digital model of the first jaw between he first stage of the treatment plan and the second stage of the treatment plan by changing the position of the plurality of digital bite adjustment structures on the corresponding plurality of digital tooth receiving cavities of the digital model of the appliance of the first jaw at a second stage of the treatment plan to create a digital model of the appliance for the first jaw for a second stage (page 43 lines 25-30 disclosing the treatment includes a number of steps with each step being a different appliance that provides the different occlusion at each step and thus for the first jaw at a first stage and second stage at least as required by a number of steps),
the digital model of the appliance for the first jaw for the second stage having the first surface shape (Fig. 28 showing examples of the changing in the DBAS 2812 for different stages of 2811” and each step would have an individual appliance digital model page 43 lines 25-30) ; and
providing the digital model of the first jaw for fabrication of physical models corresponding to the fist jaw at the first stage and the second stages of the treatment plan for formation of appliances thereover such that the surfaces of the appliances would inherit a surface geometry of the plurality of the digital bite adjustment structures (page 12 lines 21-26 outputting of a digital model of the appliance) of the first jaw for the first stage and the digital model of the appliance for the second stage for fabrication of physical appliances of the first jaw at the first and the second stages of the treatment plan wherein the physical appliances are fabricated based on the digital model of the appliance of the first jaw for the first stage and the second stages of the treatment plan(page 44 lines 12-18 disclosing “each step of the treatment plan requires a specific orthodontic appliance. Each specific orthodontic appliance may be manufactured from a virtual orthodontic appliance generated with the method according to the present invention”, page 4 lines 17-24 disclosing the thermoforming of the appliances would be thermoformed over a dental model).
Barthe discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the disocclusion is for allowing for tooth extrusion.
However, Phan discloses a method of orthodontic treatment (title ant abstract) including the placement of bite adjustment structures on posterior teeth to providing disocclusion to allow for tooth extrusion (column 4 line 64-column 5 line 12 disclosing the placing of protrusions on posterior teeth which would allow extrusion of teeth by having them be unopposed and to extrude).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the disocclusion to allow for tooth extraction by the disocclusion as taught by Phan into the disocclusion as taught by Barthe for the purpose of treating crossbites in a patient or beneficial vertical dental relationship altering as taught by Phan (column 5 lines 1-4).
Regarding claims 6 and16, Barthe further discloses where the adjusting further comprises: changing the surface shape of the plurality of digital bite adjustment structures on the corresponding plurality of digital tooth receiving cavities of the posterior digital model of the appliance of the first jaw (fig. 28 element 2812 has its surface shape changed, page 43 lines 16-28 disclosing the series of steps would be made for each step in a treatment plan).
Regarding claims 7 and 17, Barthe further discloses wherein the changing the location of the plurality of digital bite adjustment structures includes changing a vertical relationship between stages to correct for a deep bite (Fig. 28 showing different vertical relationships and thus locations, Fig. 30 having a selected vertical shape to the DBAS , page 48 lines 30-31 disclosing the adjustment for correction of overbite).
Regarding claims 8 and 18, Berthe further discloses wherein the adjusting further comprises: changing an orientation of the plurality of digital bite adjustment structures on the corresponding plurality of digital tooth receiving cavities of the digital model posterior teeth of the appliance of the first jaw (Fig. 28 element 2812 having its slope/orientation changed based on the series of teeth movements, page 109 line 22-page 110 line 8 the DBAS can be changed for different tooth positions).
Regarding claims 10 and 20, Barthe further discloses wherein the digital bite adjustment structures adjust an amount of disocclusion between the posterior and/or anterior teeth (page 48 lines 30-31 a disocclusion would be needed to allow for over-eruption of molars, Figs. 26a-e showing disocclusion by the appliance).
Regarding claims 11 and 21, Barthe/Phan as combined further discloses wherein changing the position of the plurality of digital bite adjustment structures is based on changes in intrusion or extrusion of the tooth (Fig. 28 showing movement of a tooth on the opposing jaw is used to change the location of the portions of the DBAS outer surface, as Barthe/Phan where combined to allow for the disocclusion to allow for extrusion of an erupting tooth the changes would be made to allow for the tooth to extrude by erupting until at the desired vertical relation as per Phan above).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Barthe et al. (WO 2012140021) in view of Phan et al. (US 6,572,372) as applied to claims and 12 above respectively and further in view of Kuo et al. (US 2010/0129763 A1).
Barthe/Phan discloses structure substantially identical to the instant application as discussed above including where Barthe discloses positioning a second plurality of digital bite adjustment structures on each of a plurality of posterior digital teeth of a digital model of a second jaw at a first stage of a treatment plan, the first plurality of bite adjustment structures having contours and the second plurality of digital bite adjustment structures having contours (Fig. 29 showing opposing first and second bite adjustment structures at 2901’ and 2902’ with cross-sectional contour shapes), but fails to explicitly disclose where the first structures are shaped to fit in contours of the second bite structures.
However, Kuo discloses a method of providing a sequential appliances for orthodontic treatment to reposition a patients teeth (abstract) including a first plurality of bite adjustment structures on a first appliance that are shaped to fit in contours of a second plurality of bite adjustment structures (Fig. 4a/4b showing interfiting of structures at 70).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the bite structures to have shapes that would allow them to fit into each other’s contours as taught by Kuo into the bites adjustment structures as taught by Barthe/Phan for the purpose of enhancing distribution of localized forces on the surrounding tissue and controlling lateral coupling of upper and lower teeth as taught by Kuo (paragraph [0036] lines 1-7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892.
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/M.P.S/ Examiner, Art Unit 3772 01/06/2026
/EDELMIRA BOSQUES/ Supervisory Patent Examiner, Art Unit 3772