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 .
Applicant’s amendment
Applicant’s amendment filed 12/4/2023 has been received and entered. Claims 1-15 have been amended.
Claims 1-15 are pending.
Priority
This application filed 12/4/2023 is a 371 national stage filing of PCT/ES2022/070301 filed 5/17/2022 and claims benefit to foreign application EP21382508.6 filed 6/7/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. See paper entered 12/4/2023.
Examiner note, while the file is labeled as the certified copy, it appears inconsistent in size and lacks drawings that are present in the instant application. It is note clear that the file provided is the proper or complete file as 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 1-15 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. Specifically claim 1 contains the trademark/trade name ‘CAD’. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a specific type of computer program applied for the analysis steps and, accordingly, the identification/description is indefinite.
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 1-15 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.
Claim analysis
Claim 1 has been amended and is generally directed to a method of designing an intraoral device using CAD software. More specifically, the claim requires providing a scan in the form of a mesh or piece of at least one arch and steps of design comprising segmenting the mesh into dental pieces and assigning a heat point to the dental pieces through thermal simulation, defining local vectors or centroids to each piece for defining a support curve of the device. Dependent claims provide for modifying the contour and thickness to affect a prosthetic for treatment needs, and steps for designing and establishing the thickness for the resulting prosthetic. While generic to any treatment and any prosthetic device or orthodontic systems, given the guidance of the specification the process can result in the design such as that described and provided in Figures 7 or 9 for example.
For step 1 of the 101 analysis, the claims are found to be directed to a statutory category of a process.
For step 2A of the 101 analysis, the judicial exception of the claims are the steps of taking a mesh image representing a form of intraoral device and assessing or simulating the possible various pieces that are represented based on possible heat distribution or thermal simulation between the pieces. Dependent claims provide for more detailed steps and modification of the device features such as thickness or placement of holes. In review of the specification, the claims provide generically for the use of CAD and do not have any specific definition or rules which are applied in the thermal simulation or in the assessment of support curves or contours in designing a intraoral device. The steps of assessing one image and designing a device around that image as provided are considered instructional steps. While the claims recite the use of CAD and thermal simulation, no specific requirements are set forth in the claims nor required by definition in the specification and appear to be instructions to use computer programs in the 3D representation of a patients oral arch and designing around it any desired dental piece. The judicial exception is a set of instructions for analysis of images representing at least one arch of a patient and assessing so that the dental pieces are considered separate, and appear to fall into the category of Mental Processes, that is concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Here, while the claims broadly recite the use of CAD, there is no specific application and the claims broadly encompass assessing mesh images and possible fit of an intraoral device. The breadth of “segmenting” and “defining” encompasses non-transformative visual assessment of an individual oral image and general instructions for assessing thickness and height of a dental intraoral device. This breadth does not impose a meaningful limit on the claim scope beyond using CAD to represent the image(s) for visual assessment during design. Although the claims recite “through the use of CAD”, the courts have also identified limitations that did not integrate a judicial exception into a practical application; for example, merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f). Computing, constructing images and using CAD image models was well understood, conventional, and routinely performed in the art at the time the application was filed. Furthermore, the limitation of using CAD during the assessment does not change the steps to be performed with respect to design and appears to only be a tool for visual assessment. See MPEP § 2106.05(g) for a discussion on adding insignificant extra-solution (both pre-solution and post-solution) activity to the judicial exception. See also MPEP § 2106.05(h) for a discussion on generally linking the use of a judicial exception to a particular technological environment or field of use. The claims appear to fall into the category of mental processes, as concepts performed in the human mind (including an observation, evaluation, judgment, opinion) because there is no apparent complexity to or amount of data that is collected and analyzed as presently claimed.
Recent guidance from the office requires that the judicial exception be evaluated under a second prong to determine whether the judicial exception is practically applied. In the instant case, the claims do not have an additional element beyond using CAD in the design of a device. This judicial exception requires steps recited at high level of generality and are only practiced using a computer program that renders 3D images, and is not found to be a practical application of the judicial exception as broadly set forth.
For step 2B of the 101 analysis, none of the independent claims recites additional elements beyond the use of a computer, and with respect to computer image data are found to be the steps of obtaining image data. As such, the claims do not provide for any additional element to consider under step 2B to which the design steps are applied. Given the art of record, it appears that the steps provided are steps that were previously done without CAD, and also performed without the application of thermal simulation with the design of oral devices (see IDS and Align Technology, CN 115884727 for example). It is noted that in explaining the Alice framework, the Court wrote that "[i]n cases involving software innovations, [the step one] inquiry often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool." The Court further noted that "[s]ince Alice, we have found software inventions to be patent-eligible where they have made non-abstract improvements to existing technological processes and computer technology." Moreover, these improvements must be specific -- "[a]n improved result, without more stated in the claim, is not enough to confer eligibility to an otherwise abstract idea . . . [t]o be patent-eligible, the claims must recite a specific means or method that solves a problem in an existing technological process." As indicated in the summary of the judicial exception above and in view of the teachings of the specification, the steps are drawn to analysis of image data. While the instructions of a CAD program are stored on a medium and would be implemented on a computer, together the steps do not appear to result in significantly more than a means to compare or assess image data in the design of an oral device. The judicial exception of the method as claimed can be performed by hand and in light of the teaching of the cited art and specification on a computer with image software. In review of the instant specification the methods do not appear to require a special type of processor and can be performed on a general purpose computer. Dependent claims set forth additional steps which are more specifically define the considerations and steps of calculating, and comparing, and do not add additional elements which result in significantly more to the claimed method for the analysis. No additional steps are recited in the instantly claimed invention that would amount to significantly more than the judicial exception. Without additional limitations, a process that employs CAD algorithms to manipulate existing information represented as mesh images to generate additional information is not patent eligible. In other words, patenting abstract idea (designing probes to a target sequence) cannot be circumvented by attempting to limit the use to a particular technological environment or purpose and desired result.
One way to overcome a rejection for non-patent-eligible subject matter is to persuasively argue that the claimed subject matter is not directed to a judicial exception. Another way for the applicants to overcome the rejection is to persuasively argue that the claims contain elements in addition to the judicial exception that either individually or as an ordered combination are not well understood, routine, or conventional. Another way for the applicants to overcome the rejection is to persuasively argue that the claims as a whole result in an improvement to a technology. Persuasive evidence for an improvement to a technology could be a comparison of results of the claimed subject matter with results of the prior art, or arguments based on scientific reasoning that the claimed subject matter inherently results an improvement over the prior art. The applicants should show why the claims require the improvement in all embodiments.
Conclusion
No claim is allowed.
The art of record teaches that CAD tools can be used to model 2D and 3D images, and that it is a computer program used in dental design (see US 2018/0303581 A1-of record). While certain CAD programs have the function and ability to provide for thermal analysis of a design, not all do. Importantly for the claimed invention, while CAD was known and used in dental designs, there was no motivation to apply heat points to portions of a design and apply thermal simulations for segmenting the mesh representation in CAD. In a search of the relevant art, the closest art found was Align Technology, CN 115884727 which provides for design and analysis of dental arches and suggests representation of the snap-fit as ‘a thermal schematic’, it fails to provide the application of heat points or more generally the thermal analysis using a CAD tool.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph T Woitach whose telephone number is (571)272-0739. The examiner can normally be reached Mon-Fri; 8:00-4:00.
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/Joseph Woitach/Primary Examiner, Art Unit 1687
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