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 .
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 12-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception 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 12-19 which are directed to a process of designing an orthodontic appliance with the steps of receiving data model, adjusting the data of the model, generating a model for intermediate treatment positions, configuring the data of a shape profile of an orthodontic expander model to engage lingual sides of a patient palate, and outputting data of a palatal expander model which amounts to data generation and manipulation which would be intended to operate on a generic computing device. The various dependent claims all fail to add any additional steps beyond further defining the determining of the expander geometry or composition. 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 12-19, the claimed invention is 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 or by using a computer as a tool to perform the mental process - including observations, evaluations and judgements. More particularly the steps of receiving data, generating a model data, determining shape profiles of the model to engage lingual surfaces, determining different palatal region configurations, are capable of being done mentally (a dentist views a patient's dentition envisioning treatment to move teeth by a force and can determine a force needed to move the teeth based on their experience and envisions the shape of a device to produce the force and generates instructions within their mind or by use of pencil and paper or the use of a computer as a tool to perform the mental processes and the outputting could be done via paper and pencil, or by writing out a descriptive arrangement).
It is further noted that orthodontists have long practiced their trade/art of mentally determining the movement paths, forces for treatment, and geometries of appliances to move teeth on the paths and instructions, the mental trade of information with a patient by talking and drawing - well before the advent of computers - and are most certainly capable of envisioning and mentally generating movement paths, force systems, appliance geometries, appliance compositions, and instructions.
Step 2B - In regard to claims 12-19, 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 receiving data, generating model, determining an expander configurations, determining a structure rigidity and thickness to provide the determined force 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 general data manipulation based on mathematical algorithms with mental image generation and comparisons. 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 which a person would use in a digital manner of paper and pencil. 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 § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-6 and 8-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McSurdy et al. (US 2007/0178421 A1).
Regarding claims 1 and 12, McSurdy discloses a method of designing and producing a series of palatal expanders comprising a plurality of palatal expanders configured to be sequentially worn by a patient to expand the patient's palate (paragraph [0010] all disclosing a method of generating and thus designing, a from an initial model a series of expanders to expand the jaw, paragraph [0011] all disclosing all expanders are produced), the method comprising:
receiving a digital model of a patient's oral cavity in an initial position (paragraph [0010] lines 7-9 disclosing an initial electronic thus digital model of the patient’s initial position);
adjusting the digital model from the initial position to a final position in which a palate is expanded by morphing the digital model to reflect an orthopedic expansion of the patient's midline suture (paragraph [0010] lines 7-15 disclosing the initial model is used to generate a morphing to a final selected desired breadth);
generating a palatal expander model corresponding to each intermediate position of a plurality of intermediate positions of the digital model between the initial position and the final position ( paragraph [0010] lines 7-15 further disclosing the intermediate positions of electronic models are made via a series of intermediate expander geometries),
each palatal expander model including a left tooth engagement region configured to be removably worn over the patient’s teeth in a left maxillary portion of the patient’s upper jaw (Fig. 3 element LMac/LMbc being left upper molars engagement regions),
a right tooth engagement regions configured to be removably worn over the patient’s teeth in a right maxillary portion of the patient’s upper jaw (Fig. 3 element RMac/RMbc being right upper molars engagement regions),
, and
a palatal region between the left tooth engagement region and the right tooth engagement region that is configured to contact a lingual side of the patient’s palate when worn (Fig. 5 showing the lingual contact of a portion of the palatal region between the and right tooth engagement regions); and
outputting the palatal expander model corresponding to each intermediate position of the plurality of intermediate positions (paragraph [0026] all disclosing the outputting of the model such a for a computer controlled sculpting device to form templates for the expander appliances),
and wherein for each successive palatal expander in the series of palatal expanders after a first palatal expander in the sequence, the palatal region is progressively expanded relative to a mid-sagittal plane through the first palatal expander (paragraph [0017] lines 1-10).
Regarding claim 2, McSurdy further discloses wherein the palatal region is configured to add anti-tipping torque to at least one tooth to control tipping of a crown of the at least one tooth during palatal expansion by applying a lateral force on the lingual side of the palate where the palatal region contacts the lingual side of the palate (paragraph [0023] lines 8-12 disclosing that buccal tipping it limited by the teeth regions, Fig. 5 the buccal regions would transfer torque to the lingual sides of the jaw, further the lingual sides of the palate would be part of the contact region for pressure).
Regarding claims 3, 13, and 14, McSurdy further discloses wherein the palatal region model and subsequent expander is configured to add anti-tipping torque by applying the lateral force to buccally rotate the root of the at least one tooth to control tipping of the crown of the at least one tooth during palatal expansion by applying a lingual force on the lingual side of the palate (paragraph [0023] lines 8-12 disclosing that buccal tipping it limited by the teeth regions, Fig. 5 the buccal regions would transfer torque to the lingual sides of the jaw and thus some buccal rotation force to the roots, further the lingual sides of the palate would be part of the contact region for pressure and by the buccal regions of the shell over the teeth being held against tipping the lingual portion of the shell would be pressed into the lingual surfaces as well).
Regarding claims 4 and 15 McSurdy further discloses, wherein the palatal region is configured to apply a lateral expansion force where it contacts the lingual side of the patient’s palate, the force based on a planned treatment stage that is part of a planned palatal expansion treatment for the patient (Fig. 5 showing the expander for a given stage of the planned treatment would contact and apply a pressure to the lingual side of the patient’s palate and thus apply lateral expansion force).
Regarding claims 5, and 18, McSurdy further discloses wherein a first palatal expander from a first model in the series is configured to be worn earlier in treatment and contact and apply a first expansion force on the lingual side of the palate and a second expander form a second model in the series is configured to contact and apply a second expansion force on the lingual side of the palate, the first force different than the second force due to the first and second palatal models having different configurations (Fig. 5 showing the expander for a given stage of the planned treatment would contact and apply a pressure to the lingual side of the patient’s palate and thus apply lateral expansion force, and that the amount of force that the first expander from the first model would apply would be more than the amount of force a second/subsequent modeled expander would apply in paragraph [0006] lines 10-17 disclosing that the amount of pressure for each adjustment step would be eased and thus different by the next expander adjustment being less than the previous expander thus having different configurations of different forces and widths).
Regarding claim 16 McSurdy further discloses wherein for the first and second of the palatal expander models, configuring the respective palatal regions such that palatal regions of first and second palatal expanders that correspond to the first and second palatal expander models contact a lingual side of the patient’s palate when worn (Fig. 5 showing the expander for a given stage of the planned treatment would contact and apply a pressure to the lingual side of the patient’s palate) , and wherein the palatal regions of the first and second palatal expander models have different configurations (paragraph [0032] lines 1-12 disclosing the configuration of the palatal regions would be different by the second configured to be at least 0.5mm wider than the first) .
Regarding claims 6 and 17, McSurdy further discloses wherein the first and second palatal expanders are designed and configured to achieve different expansion distances during respective stages during the planned palatal expansion treatment for the patient (paragraph [0032] all disclosing that the first/second expanders would each have different expansion distances, as the second expander would have an expansion distance greater than the previous expander until the final position was achieved).
Regarding claims 8 and 9, McSurdy further discloses wherein for the one or more palatal expanders in the series, an average thickness of the palatal region is different/greater than an average thickness of an occlusal region of the left and right tooth engagement regions (Fig. 5 showing a thickness of the center of the palatal portion is thicker that the occlusal regions), and an average thickness of a buccal region of the left and right tooth engagement regions is less than the average thickness of the occlusal region (Fig. 5 showing the thickness of the buccal regions being thinner than that of the occlusal regions).
Regarding claim 10, McSurdy further discloses where for the one or more palatal expanders in the series, the palatal expander comprises a buccal extension region configured to extend at least partially over the patient's gingiva when the palatal expander is worn by the patient (fig. 2 showing a portion of the buccal part of the expander extends over at least a portion of the gingiva).
Regarding claim 11, McSurdy further discloses where for the one or more palatal expanders in the series, the palatal expander includes a central region configured to create a gap between the patient’s palate and the palatal region (Fig. 5 showing that as the palatal suture would release and widen a central portion of the expander would no longer be in contact with the center of the palate a thus gap would form).
Further regarding claim 19, McSurdy further discloses where the first palatal expander is designed to be worn in a treatment stage that occurs earlier than a treatment stage during which the second palatal expander is designed to be worn, the treatment stages part of the planned palatal expansion treatment for the patient (paragraph [0033] lines 1-9 disclosing the first palatal expander is worn first and then is replaced by a number of intermediate expanders thus the next intermediate expander being the designed to be worn after the first).
Further regarding claim 20, McSurdy further discloses fabricating a series of monolithic palatal expanders from the palatal expander model corresponding to each intermediate position of the plurality of intermediate positions (paragraph [0011] all disclosing that all the expanders are produced and thus all the intermediate position expanders are fabricated).
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 (i.e., changing from AIA to pre-AIA ) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over McSurdy et al. (US 2007/0178421 A1) in view of Wen et al. (WO 2006/096558 A2).
Regarding claim 7, McSurdy discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the palatal expanders are configured to achieve different expansion distances or rates by having different stiffness.
However, Wen discloses a series of expanders to widen a palate (title and abstract, paragraph [0065 all disclosing expanding the upper palate), where the expander would have a palate region that would have different stiffness between expanders (paragraph [0041] lines 1-7 disclosing the different portions of the different appliances can have different hardness and thus stiffnesses)
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 use of different stiffness in appliances as taught by Wen into the series of appliances as taught by McSurdy for the purpose of providing for the ability to enhance performance of the appliances as taught by Wen (abstract disclosing the varying stiffness would enhance performance of dental aligners).
Double Patenting
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,109,090. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 12,109,090 is a species of current claim 1.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,109,090. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 12,109,090 is a species of current claim 2.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,109,090. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of U.S. Patent No. 12,109,090 is a species of current claim 3.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,109,090. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of U.S. Patent No. 12,109,090 is a species of current claim 8.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,109,090. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 of U.S. Patent No. 12,109,090 is a species of current claim 9.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,109,090. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 of U.S. Patent No. 12,109,090 is a species of current claim 10.
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 12/27/2025
/EDELMIRA BOSQUES/ Supervisory Patent Examiner, Art Unit 3772