Status under America Invents Act
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Acknowledgement of Election
In response to the restriction requirement of January 7, 2026 applicant elected without traverse the invention identified as Group 1 including claims 1-32. Claims 33-37 directed to a non-elected invention have been withdrawn from further consideration at this time.
Rejection based on 35 U.S.C. 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, 3-17, and 19-32 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 determining patent subject matter eligibility under 35 U.S.C. 101 the U.S. Patent Office issued guidance on January 7, 2019 that was then updated in October 2019. That guidance has since been incorporated into the Ninth Edition, Revision R-07.2022 of the Manual of Patent Examination Procedure (MPEP), particularly Sections 2103 through 2106.07(c). The Step 1, Step 2A Prong One, Step 2A Prong Two, and Step 2B determinations set forth in the Patent Office guidance and MPEP are addressed below.
35 U.S.C. 101 – Step 1 – Determination as to whether claims are directed to a statutory category specified in 35 U.S.C. 101 (MPEP 2106.03) -
Claims 1-13 and 17-29 are directed to a “method to manufacture a customized dental implant” and consequently interpreted as generally falling within the statutory category of a “useful process.”
Claims 14-16 and 30-32 directed to “a computer program stored or storable on a non-transitory processor-readable memory as executable instructions” when given their broadest reasonable interpretation includes a program comprised of a transitory signal(s) that are not stored in a tangible physical memory, but rather simply capable of being stored (“storable”) in a physical memory. A computer program in the form of a transitory signal that is included within the scope of the present claims does not fall within any of the four statutory categories defined by 35 U.S.C. 101. Accordingly, claims 14-16 and 30-32 do not meet the step 1 requirement in the 35 U.S.C. 101 statutory analysis.
35 U.S.C. 101 – Step 2A Prong One - Determination as to whether the claims recite a Judicial Exception including an abstract idea, law of nature, or natural phenomenon (MPEP 2106.04). Claims 1, 3-17, 19-32, as a whole, are directed to the Judicial Exception (MPEP 2106.04) of an abstract idea (MPEP 2106.04(a)). The claimed invention is directed to a mental process – concepts that are capable of being performed in the human mind – including observations, evaluations and judgements (MPEP 2106.04(a)(2)).
More particularly, with respect to “method of manufacture” claims 1 and 17, the steps of “obtaining a proposed specification of a dental implant”; “obtaining a trained shape model”; “obtaining a data set”; “forming an adapted shape model”; and “generating an updated specification” are all capable of being performed mentally. For example, a practitioner can mentally/visually/audibly obtain a proposed specification for a dental implant; mentally/visually/audibly obtain a trained shaped model; mentally/visually/audibly obtain a data set including visual representatives; form an adaptive shape model (with or without pencil and paper) based on at least a portion of the trained shaped model and then generate (with or without pencil and paper) an updated specification of the dental implant. The claimed method is set forth in a high level of generality with no limitations as to the degree of detail required, no limitations as to how the adapted shaped model is constructed or trained or the factors or calculations made in generating the updated specification. The broad general scope of the steps set forth in the claims supports the mental process determination.
In regard to “computer program” claims 14-16 and 30-32, to the limited extent that one arguably determines that the claims fall with one of the four statutory categories, then like claims 1 and 17, the program steps of “obtaining a proposed specification of a dental implant”; “obtaining a trained shape model”; “obtaining a data set”; “forming an adapted shape model”; and “generating an updated specification” are all capable of being performed mentally as described above.
35 U.S.C. 101 – Step 2A Prong Two requires a determination as to whether the claims as a whole integrate the Judicial Exception into a Practical Application of that exception (MPEP 2106.04(d)).
With regard to “method of manufacture” claims 1, 3-13, 17 and 19-29, the recited steps do not require that the method be implemented by a particular machine (see MPEP 2106.05(b)), nor do the claims require the method to particularly transform a particular article (see MPEP2106.05(c)). At most, the claims require that data and an algorithm (‘trained shaped model”) be obtained and then used to form an adapted shape model and generate an updated specification of an implant. There is no requirement in the claims that the method even be performed on a computer processor. None of the recited steps link the claimed to method a physical object, and are little more than intangible ideas that fail to integrate the judicial exception into a practical application. In contrast dependent claims 2 and 18, which further limit the method to producing a physical dental implant serve to integrate the judicial exception into a practical application.
In regard to claims 14-16 and 30-32 directed to a “computer program” that may or may not be stored on a physical non-transitory computer memory device, as well as, “method of manufacture” claims 1, 3-13, 17 and 19-29, to the limited extent that any of these claims are interpreted as requiring (or implicitly requiring) some type of computer hardware, then they still fail to integrate the Judicial Exception into a Practical Application of the exception (see MPEP 2106.04(a)(2)(III)(C)). There is no disclosure that the computer program steps improve the manner in which the computer/computer operates (see MPEP 2106.04(d)(1)). The claims do not go beyond generally linking the judicial exception to a computer environment. The claims do not require that the method be implemented by a particular machine (see MPEP 2106.05(b)), nor do the claims require the method to particularly transform a particular article (see MPEP2106.05(c)). The claims as whole fail to integrate the abstract idea (the “judicial exception”) into a practical application of that abstract idea.
The claims at most are directed solely to a digital virtual environment where data is obtained and then processed (“forming”, “generating”) – there are no additional elements integrating the judicial exception into a practical solution – the computer method is not used to operate a manufacturing device, the computer method is not used to improve the functioning of a computer, the computer method is not used to transform a particular article into a different state or thing – there is no meaningful limitation beyond generally linking the use of the judicial exception to a particular technological environment.
35 U.S.C. 101 – Step 2B requires a determination as to whether the claims amount to Significantly More than the Judicial Exception (MPEP 2106.05). As set forth above with respect to Step 2A Pong One the claimed computer steps of obtaining data, obtaining an algorithm, processing the data (“forming an adapted shape model”, “generating an updated specification”) as set forth in claims 1, 3-17, and 19-32 are all capable of being performed mentally and represent nothing more than concepts related to performing observations, evaluations and judgements which fall within the judicial exception. At most the claims require a generic general-purpose computer or memory. There is no disclosure in the written description that the computer and memory are anything more than generic components, nor is there any disclosure that the instructions improve the manner in which the computer device operates. The mere recitation in the claims of a generic conventional computer processor and memory that are intended to be 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 processing and displaying data 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 a process of presenting 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 system and method fall 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.
Additionally, it noted to the extent that the limitations directed to “obtaining a trained shape model” are interpreted as requiring the method step use artificial intelligence/machine learning, then applicant’s attention is directed to the recent Federal Circuit decision Recentive Analytics, Inc. v. Fox Corp (Fed Cir. 2025) where the court held that “Machine learning is a burgeoning and increasingly important field and may lead to patent-eligible improvements in technology. Today, we hold only that patents that do no more than claim the application of generic machine learning to new data environments, without disclosing improvements to the machine learning models to be applied, are patent ineligible under § 101.” The claimed generic use of a machine learning algorithm fails to integrate the Judicial Exception of an abstract idea into a practical application or amount to significantly more than the judicial exception.
Rejections based on Prior Art
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.
Claims 1-32 are rejected under 35 U.S.C. 103 as being unpatentable over Wismeijer (US 2018/0140392) in view of Vallabh et al (The morphology of the human mandible: A computational model study (cited by applicant)).
In regard to independent claims 1, 14, 17, and 30, Wismeijer discloses a method of manufacturing a customized dental implant wherein a proposed specification of a dental implant including a root portion and occlusal facing portion are obtained (paragraph [0043] the “optimum dimensions of the dental implant” are established from a 3D model of the scanned area – implies that the remaining specifications of the implant are merely “obtained”); obtaining a 3D model (paragraph [0043] – “virtual 3D model of the scanned area”); obtaining a data set including one or more virtual representations of one or more dental anatomy elements (paragraph [0043] – “virtual 3D model of the scanned area”); and generating an updated specification by updating the proposed specification of the dental implant (paragraph [0043] “on basis of this virtual 3D model the optimum dimensions of the dental implant can be calculated. This results in a virtual model of the designed implant”).
Wismeijer fails to specifically disclose (i) “obtaining a trained shape model, the trained shape model being descriptive of a statistical dental anatomy model, the statistical dental anatomy model including one or more statistical dental anatomy element shape models”; (ii) “forming an adapted shape model based on at least a portion of the trained shape model to fit one or more virtual representations”; and (iii) “generating the adapted specification based at least in part on the adapted shape model.” Wismeijer generates the adapted dimensions/specifications of the implant based on a non-statistical shape model – i.e. a “virtual 3D model of the scanned area” rather than a statistical shape model adapted to the patient’s anatomy. Patient adapted statistical shape models, however, are well known in the dental surgical planning as evidenced for example by Vallabh et al who teach that trained statistical shape models (SSMs) of partially edentulous mandibles can be used to generate complete three-dimensional models of mandibles. Vallabh et al teach that “[t]he capability to rapidly generate accurate patient specific shape predictive models of the mandible may useful for implant development and pre-operative planning” (abstract). One of ordinary skill in the art, before the effective filing date of the claimed invention would have found it obvious in view of the teachings by Vallabh et al to apply statistical shape models adapted to a particular person’s anatomy as a viable alternative to scanned 3D models and used to provide the geometric information needed to adjust the dimensions/specifications of dental implants. In regard to dependent claims 3-13, 15, 16, 19-29, 31 and 32 further defining the data sets that are obtained and used for updating the specifications of the dental implant, it would have been obvious to one of ordinary skill in the art to have used more detailed anatomical data in the method determining the implant dimensions/specifications.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ralph Lewis whose telephone number is (571)272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712
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