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.
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 1-20 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-01.2024 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 1-20 are directed to a “method of designing a palatal expander for a patient” and a “method of designing a series of palatal expanders for treating a patient” and are interpreted as falling within the “new and useful process” statutory class of 35 U.S.C. 101.
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 1-20, 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 independent claims 1 and 13, the method steps of “forming a digital model of the palatal expander based on a scan of the patient’s dental arch” may be performed mentally (or with paper and pencil)(e.g. an orthodontist upon viewing a scan of a patient’s upper arch envisions or draws a model of a palatal expander for the patient); the additional step of “forming the palatal region such that . . . the palatal expander is configured to apply a lateral force” may be performed mentally (e.g. an orthodontist envisions or draws the palatal expander model to apply a lateral force across the patient’s palate); the additional step of forming attachment regions on the buccal sides of the model may be performed mentally (e.g. an orthodontist envisions or draws attachment regions on a buccal side of a model of a palatal expander for the patient); and the “forming at least on breach region of the digital model” may be performed mentally (e.g. an orthodontist envisions or draws a breach region in a model of a palatal expander for the patient). Likewise with respect to claim 13, the additional requirement of performing the method for a series of palatal expander digital models could be performed mentally as described above. Dependent claims 3-12, 14-17, 19 and 20, likewise fail to provide for any method step limitations in the design of a palatal expander that could not be determined mentally (with or without paper and pencil) by an orthodontist in the practice of orthodontics.
35 U.S.C. 101 – Step 2A Prong Two requires a determination as to whether the claims as a whole integrates the Judicial Exception into a Practical Application of that exception (MPEP 2106.04(d)). The limitation of claims 1-20 requiring the formation of a “digital model” suggests the use of a computer system. To the limited extent that the “digital model” limitation is interpreted as requiring a computer system, then it is noted that the “computer system” amounts to an “additional element” beyond the abstract idea, however, the performance of a mental process on a generic computer/computer readable medium fails 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 method steps/computer instructions improve the manner in which the computer (or computer readable medium) 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 are directed solely to a digital virtual environment where data is input (“accessing”) and processed (“determining”; “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 methods of designing a palatal expander 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. The “digital model” limitation requires at most a generic general purpose computer system. There is no disclosure in the written description that the implied computer device is anything more than a generic component, 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 that is 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 inputting and processing 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.
Moreover, it is noted that the method claims are written at a high level of generality. The claims do set forth any requirements regarding the accuracy or tolerance of the “digital model.” The method claims do not set forth how any of the determinations that are made for generating the structure of the digital palatal expander (e.g. is a basic digital model used which is then modified to fit a particular patient?). The method claims do not set forth what factors that are considered in the generation of the digital model, what computations or determinations are made in the “forming” of a digital model; what computations and determinations are considered in “forming” the palatal region and “forming” of the attachment regions; or what determinations are used in “forming” the breach region. But instead the claims are quite broad in encompassing any manner of making such “forming” steps which further supports the abstract idea determination.
Rejection based on 35 U.S.C. 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The written description fails to provide an adequate basis to enable on skilled in the art to make and use the claimed invention without undue experimentation. More particularly, the written description fails to set forth how any of the determinations are made for generating the structure of the digital palatal expander (e.g. is a basic digital model used which is then modified to fit a particular patient?). The specification does not set forth what factors that are considered in the claimed generation of the digital model, what computations or determinations are made in the claimed “forming” of a digital model; what computations and determinations are considered in claimed “forming” the palatal region and the claimed “forming” of the attachment regions; or what determinations are used in the claimed “forming” of the breach region. The written description provides several statements that a digital process may be used (e.g. paragraph [0134] “[i]t may be particularly advantageous to provide a digital planning process in which a digital model of the patients upper jaw (e.g., teeth, palate and gingiva), and in some cases the subject’s lower jaw (e.g., teeth and/or gingiva) may be modified to plan the series of expanders”), but it never adequately sets forth how any of the “forming” steps of the currently claimed invention are performed.
MPEP 2164.01(a) sets forth factors to be considered in determining the compliance with the enablement requirement those factors include –
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In the present application, the claims are very broad having little to no limits or direction on how each of the “forming” steps is to be performed, nor is any direction provided in the written description, other than general assertions that the disclosed device could be formed from a digital model. The person of ordinary skill in the art, an orthodontist or computer programmer, would require a significant amount of experimentation and work in determining what factors and determinations are to be made in “forming a digital model” which includes the “forming the palatal region”, “forming attachment regions” and “forming at least one breach region.” The lengthy description provides no examples of how such “forming” steps are digitaly performed.
Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over
Claims 1-20 of U.S. Patent No. 12,097,085.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims of 12,097,085 set forth a palatal expander having all of the structural elements of the presently claimed “digital model of the palatal expander” – (e.g. patented claim 1 sets forth a “palatal region”, an “attachment region”, and a “breach region corresponding to a thinned region of the palatal expander that extends anteriorly to posteriorly in the palatal region or an occlusal portion”). Merely, setting forth a broadly claimed method of “forming a digital model” of the previously patented palatal expander so that the palatal expander may be readily manufactured in a prior art 3D printing process would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Examiner Comment
The prior art of record does not disclose or reasonably teach to one of ordinary skill in the art the claimed invention of a digital model of a palatal expander having a palatal region, attachment regions and a breach region corresponding to a thinned region of the palatal expander that extends anteriorly to posteriorly as specifically set forth in the present claims and as specifically set forth with respect to the other claimed elements.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712