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 .
Priority
Applicant’s claim for the benefit of prior-filed application(s) U.S. Patent Application No. 17/829,3339, filed May 31, 2022, which is a continuation of U.S. Patent Application No. 17/003,85/, filed August 26, 2020, which is a continuation of U.S. Patent Application No. 15/839,730, filed December 12, 2017, which claims the benefit of U.S. Provisional Application No. 62/449,982, filed January 24, 2017, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e), 120 and 365(c) as follows:
For all listed prior applications, claim 21 is not supported. The corrective actions listed in Table 4 include interproximal reduction, adding an attachment and tooth extraction, but do not include palatal expansion. Palatal expansion is only mentioned in reference to the clinical signs (refer to Table 2).
For the purpose of examination, the priority date for claims 1-20 is 01/24/2017.
For the purpose of examination, the priority date for claim 21 is 12/21/2023.
Claim Objections
Claims 1, 4 19, and 20 are objected to because of the following informalities:
For claim 4, “dental of the patient arch” should be “dental arch of the patient”.
For claims 1, 19 and 20, Examiner recommends modifying the last limitation to remove, “wherein the one or more orthodontic aligners are manufactured based on one or more virtual three-dimensional (3D) models corresponding to the updated treatment plan”. This portion of the claim is redundant with the beginning of the claim, which already states, “causing one or more orthodontic aligners associated with the updated orthodontic treatment plan to be manufactured”.
For claims 19, lines 6-15, and claim 20, lines 4-9, Examiner recommends amending the variations of “dental arch” and “patient’s dental arch” to “dental arch of the patient” for consistency.
For claim 20, Examiner recommends modifying the language of the last limitation from, "causing one or more orthodontic aligners associated with the updated orthodontic treatment plan to be manufactured “manufacturing one or more orthodontic aligners associated with the updated orthodontic treatment plan .
Appropriate correction is required.
Claim Rejections - 35 USC § 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.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The corrective actions listed in Table 4 include
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.
Claim(s) 1-2, 8, 14-17, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kitching et al. (US 20140335466 A1), herein referred to as Kitching.
Regarding claim 1, Kitching discloses a system (700) comprising:
a computing device (computer of 700) comprising a memory (708) and a processor (702), the computing device configured to (refer to Paragraphs [0071], [0073]; a data processing system including one or more computers includes a processor (702) and memory subsystem (708) is used to execute the methods and processes described):
receive scan data of an actual condition of a of a patient at a stage of an orthodontic treatment plan (600) (refer to Paragraph [0051]; current jaw data representing an actual arrangement of the patient’s teeth is received);
make a comparison of the actual condition of the of the patient as depicted in the scan data to a planned condition of the of the patient for the stage of the orthodontic treatment plan (606) (refer to Paragraphs [0052], [0053]; the previously segmented model and current teeth image are compared, wherein the previously segmented model is a digital model of the patient’s teeth at a planned successive tooth arrangement);
determine, based on a result of the comparison, that a planned final position for one or more teeth of the of the patient is unachievable without corrective action (refer to Paragraphs [0060], [0070], Fig. 9C; if the patient’s teeth are determined off track, the original treatment plan will be suspended, wherein the original treatment plan includes an initial final arrangement; the suspension of the original plan demonstrates that the initial final arrangement is not achievable or too difficult to achieve without modifying the treatment plan, which equates to corrective action);
determine a new final position for the one or more teeth of the of the patient (622) (refer to Paragraph [0070] and Fig. 9C; a revised treatment plan includes generating a new final arrangement of teeth); [[and]]
update the orthodontic treatment plan to replace the planned final position for the one or more teeth of the of the patient with the new final position for the one or more teeth of the of the patient (622) (refer to Paragraph [0060] and Fig. 9C; a modified or revised treatment plan will be generated, with the revised treatment plan including the new final arrangement of teeth); and
cause one or more orthodontic aligners associated with the updated orthodontic treatment plan to be manufactured, wherein the one or more orthodontic aligners are manufactured based on one or more virtual three-dimensional (3D) models corresponding to the updated treatment plan (Refer to Paragraphs [0041], [0046], [0074]; dental appliances are fabricated based on data set from a treatment plan, which includes the modified or revised treatment plans; the data set includes models of the teeth generated by 3-dimensional treatment planning software).
Regarding claim 2, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
generate the one or more virtual three-dimensional (3D) models associated with one or more new orthodontic aligners to be manufactured in accordance with the updated orthodontic treatment plan (refer to Paragraphs [0005], [0036], [0046] and Fig. 3; after revising or modifying a treatment plan, appliances can be generated, where the aligners are designed with 3-dimensional planning/design tools and each appliance configuration corresponds to a planned successive arrangement of teeth).
Regarding claim 8, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine one or more clinical signs of a deviation from the planned condition of the of the patient based on the comparison (refer to Paragraph [0059]; various clinical and/or positional parameters can be examined and compared for determination as to whether the patient’s teeth are deviating from an expected arrangement) wherein the one or more clinical signs comprise at least one of:
a new tooth having erupted;
a change in tooth geometry comprising at least one of a broken tooth, an unexpected crown, an unexpected filling, or a missing filling (refer to Paragraphs [0053], [0054]; in step 606, the previously segmented teeth model is compared to the current teeth model, mismatches which occur between the two models can result from a tooth filling); or
a tooth eruption being greater than planned.
Regarding claim 14, Kitching discloses the system (700) of claim 1, wherein the update to the orthodontic treatment plan comprises a modified staging of the orthodontic treatment plan (refer to Paragraph [0025] and Fig. 9C; a plurality of stages of teeth correction is shown as part of the revised treatment plan).
Regarding claim 15, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine one or more differences between the actual condition of the of the patient as depicted in the scan data and the planned condition of the of the patient for the stage of the orthodontic treatment plan based on the comparison (618) (refer to Paragraph [0059]; differences are determined between a current teeth image and planned teeth image), wherein the new final position for the one or more teeth of the of the patient is determined at least in part based on the one or more differences (refer to Paragraph [0060]; a modified or revised treatment plan, which includes a new final position, is generated as a result of the comparison in step 618).
Regarding claim 16, Kitching discloses the system (700) of claim 15, wherein the computing device (computer of 700) is further configured to:
output a graphical representation of the one or more differences between the actual condition of the of the patient and the planned condition of the of the patient (refer to Paragraph [0062] and Fig. 8; a graphical representation of the previously segmented model is overlaid on the current teeth image to demonstrate the differences between the two).
Regarding claim 17, Kitching discloses the system (700) of claim 1, wherein the scan data comprises at least one of a) one or more intraoral scans of the actual condition of the of the patient (refer to Paragraph [0039]; the scan of the patient’s teeth is acquired by direct contact scanning) or b) a virtual three- dimensional model generated from the one or more intraoral scans (refer to Paragraph [0040]; the digital data set includes surface models derived from the raw data).
Regarding claim 19, Kitching discloses a non-transitory computer readable medium (712) comprising instructions that, when executed by one or more processors (702), cause the one or more processors (702) to perform operations comprising (refer to Paragraphs [0071], [0073]; the memory subsystem (708) comprises a ROM (712) for storage of instructions during program execution, which is in communication with the processor (702) for executing the methods and processes described) :
receiving scan data of an actual condition of a of a patient at a stage of an orthodontic treatment plan (600) (refer to Paragraph [0051]; current jaw data representing an actual arrangement of the patient’s teeth is received);
making a comparison of the actual condition of the (606) (refer to Paragraphs [0052], [0053]; the previously segmented model and current teeth image are compared, wherein the previously segmented model is a digital model of the patient’s teeth at a planned successive tooth arrangement);
determining, based on a result of the comparison, that a planned final position for one or more teeth of the without corrective action (refer to Paragraphs [0060], [0070], Fig. 9C; if the patient’s teeth are determined off track, the original treatment plan will be suspended, wherein the original treatment plan includes an initial final arrangement; the suspension of the original plan demonstrates that the initial final arrangement is not achievable or too difficult to achieve without modifying the treatment plan, which equates to corrective action);
determining a new final position for the one or more teeth of the (refer to Paragraph [0070] and Fig. 9C; a revised treatment plan includes generating a new final arrangement of teeth; the generation of a new treatment plan demonstrates that the revised arrangement is achievable); [[and]]
updating the orthodontic treatment plan to replace the planned final position for the one or more teeth of the position for the one or more teeth of the (622) (refer to Paragraph [0060] and Fig. 9C; a modified or revised treatment plan will be generated, with the revised treatment plan including the new final arrangement of teeth);and
causing one or more orthodontic aligners associated with the updated orthodontic treatment plan to be manufactured, wherein the one or more orthodontic aligners are manufactured based on one or more virtual three-dimensional (3D) models corresponding to the updated treatment plan(refer to Paragraphs [0041], [0046], [0074]; dental appliances are fabricated based on data set from a treatment plan, which includes the modified or revised treatment plans; the data set includes models of the teeth generated by 3-dimensional treatment planning software).
Regarding claim 20, Kitching discloses a method (Fig. 6) comprising:
receiving scan data of an actual condition of a of a patient at a stage of an orthodontic treatment plan (600) (refer to Paragraph [0051]; current jaw data representing an actual arrangement of the patient’s teeth is received);
making a comparison of the actual condition of the (606) (refer to Paragraphs [0052], [0053]; the previously segmented model and current teeth image are compared, wherein the previously segmented model is a digital model of the patient’s teeth at a planned successive tooth arrangement);
determining, based on a result of the comparison, that a planned final position for one or more teeth of the patient's dental arch is unachievable without corrective action (refer to Paragraphs [0060], [0070], Fig. 9C; if the patient’s teeth are determined off track, the original treatment plan will be suspended, wherein the original treatment plan includes an initial final arrangement; the suspension of the original plan demonstrates that the initial final arrangement is not achievable or too difficult to achieve without modifying the treatment plan, which equates to corrective action);
determining a new final position for the one or more teeth of the (refer to Paragraph [0070] and Fig. 9C; a revised treatment plan includes generating a new final arrangement of teeth; the generation of a new treatment plan demonstrates that the revised arrangement is achievable); [[and]]
updating the orthodontic treatment plan to replace the planned final position for the one or more teeth of the patient's dental arch with the new final position for the one or more teeth of the patient's dental arch (622) (refer to Paragraph [0060] and Fig. 9C; a modified or revised treatment plan will be generated, with the revised treatment plan including the new final arrangement of teeth); and
causing one or more orthodontic aligners associated with the updated orthodontic treatment plan to be manufactured, wherein the one or more orthodontic aligners are manufactured based on one or more virtual three-dimensional (3D) models corresponding to the updated treatment plan(refer to Paragraphs [0041], [0046], [0074]; dental appliances are fabricated based on data set from a treatment plan, which includes the modified or revised treatment plans; the data set includes models of the teeth generated by 3-dimensional treatment planning software).
Claim Rejections - 35 USC § 103
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.
Claim(s) 3 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching et al. (US 20140335466 A1), herein referred to as Kitching, in view of Sachdeva et al. (US 20040197727 A1), herein referred to as Sachdeva’1.
Regarding claim 3, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine one or more clinical signs of a deviation from the planned condition of the patient's dental arch (refer to Paragraph [0059]; various clinical and/or positional parameters can be examined and compared for determination as to whether the patient’s teeth are deviating from an expected arrangement); however, Kitching does not further disclose the clinical signs being related to occlusion via unplanned contact or unplanned vertical space between upper and lower teeth.
Sachdeva’1 discloses a system (100) configured for making a comparison of the actual condition of a patient’s dental arch to a planned condition in the same field of endeavor (refer to Paragraphs [0049], [0053], [0226], [0228]; treatment evaluation of a treatment set-up against the patient’s response state is performed, wherein the response state is the current representation of the patient’s orthodontic state during treatment; the system (100) is configured for performing this evaluation via a processor (12)). A computing device (10) evaluates clinical signs related to occlusion wherein the one or more clinical signs comprise an unplanned contact between one or more upper teeth and one or more lower teeth of the one or more teeth, an unplanned vertical space between one or more upper teeth and one or more lower teeth of the one or more teeth (refer to Paragraph [0317]; contacts between an upper arch and lower arch where collision would occur are in red, whereas points of no collision but a defined vertical space are in a separate color). This feature allows a user to evaluate the occlusion of the actual state of the patient dentition.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the clinical signs of a deviation of Kitching (refer to Paragraph [0059]) with occlusal clinical signs (refer to Paragraph [0317]) as taught by Sachdeva’1, in order to allow a user to evaluate the occlusion of the actual state of the patient dentition.
(New)
Regarding claim 21, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to cause a display device (718) to display one or more of the corrective actions (refer to Paragraphs [0049], [0072]; the system generates new/revised treatment options or plans; the user interface output is configured with a display that is capable of displaying the new/revised treatment options) but is silent to wherein the corrective action comprises at least one of interproximal reduction, palatal expansion, addition of an attachment to a tooth, or tooth extraction.
Sachdeva’1 discloses a system (100) configured for dental treatment plan modifications in the same field of endeavor (refer to Paragraph [0015]). The dental treatment plan modifications (corrective actions) include interproximal reduction, palatal expansion, or tooth extraction (refer to Paragraphs [0157]-[0158]; in developing a treatment plan for aligning the teeth, correction of space is accomplished by interproximal reduction, extraction and expansion of the jaw). The addition of these therapeutic strategies drives effective treatment planning (refer to Paragraph [0012]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the corrective actions of Kitching (refer to Paragraphs [0060], [0070], Fig. 9C) to include interproximal reduction, palatal expansion, or tooth extraction (refer to Paragraphs [0157]-[0158]) as taught by Sachdeva’1, in order to drive effective treatment planning (refer to Paragraph [0012]).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching et al. (US 20140335466 A1), herein referred to as Kitching, in view of Kuo (US 20070129991 A1).
Regarding claims 4-5, Kitching discloses the system (700) of claim 1, but is silent to determining the probable root causes that the planned final position of the of the patient arch being unachievable and determining the new final position for the one or more teeth of the of the patient based at least in part on the one or more probable root causes
Kuo discloses a system for performing data processing of indexing orthodontic profiles for a treatment plan in the same field of endeavor (refer to Paragraphs [0009], [0344]). The process of indexing orthodontic profile comprises the steps of receiving scan data of an actual condition of a patient dentition (refer to Paragraph [0246]), receiving a treatment goal (2930), wherein the treatment goal (2930) includes the planned final position of the one or more teeth of the patient's dental arch (refer to Paragraph [0249]; predefined treatment goals includes the tooth alignment goal of final arrangement), and is further configured to determine one or more probable root causes that contribute to the treatment goal being unachievable determine the new final position for the one or more teeth of the of the patient based at least in part on the one or more probable root causes (refer to Paragraphs [0250], [0255]; based on the modification to claim 4, the treatment plan, which includes a final arrangement of teeth, is modified based on varying individual parameters, wherein the individual parameters are equivalent to root causes for the patient’s planned treatment goal being difficult to achieve). The association of a difficulty score with specific patient parameters allows for better selection and/or modification of an appropriate treatment plan by variation of individual parameters (refer to Paragraph [0250]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method executed by the computing device (computer of 700) of Kitching with root cause identification and difficulty assignment as taught by Kuo in order to allow for better selection of an appropriate treatment plan by variation of individual parameters (refer to Paragraph [0250]).
Claim(s) 6 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching et al. (US 20140335466 A1), herein referred to as Kitching, in view of Sachdeva et al. (US 20140329194 A1), herein referred to as Sachdeva’2.
Regarding claim 6, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine one or more clinical signs of a deviation from the planned condition of the of the patient for the one or more teeth of the of the patient (refer to Paragraph [0059]; various clinical and/or positional parameters can be examined and compared for determination as to whether the patient’s teeth are deviating from an expected arrangement); however, Kitching does not further disclose wherein the clinical signs are related to root positions, and the one or more clinical signs comprise at least one of: a distance between roots of adjacent teeth being less than a threshold; a distance between a root of a tooth and an unerupted tooth being less than a threshold; or a distance between a root of a tooth and a bone boundary being less than a threshold.
Sachdeva’2. discloses a system (100) configured for planning orthodontic treatment in the same field of endeavor (refer to Paragraphs [0003], [0080]-[0082]). The computing device (10) evaluates clinical signs related to root positions for planning the orthodontic treatment (refer to Paragraph [0013]), wherein the one or more clinical signs comprise a distance between roots of adjacent teeth being less than a threshold (refer to Paragraphs [0302], [0304], [0306]; the treatment planning software identifies a tooth root abnormality such as tooth-roots entangled with each other; in the case of tooth roots being entangled, the distance between the roots of the adjacent teeth is less than a threshold of 0mm). The clinical identification of root entanglement allows for treatment plan creation or modification to correct this abnormality (refer to Paragraph [0306]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the clinical signs of a deviation of Kitching (refer to Paragraph [0059]) with root position clinical signs as taught by Sachdeva’2 (refer to Paragraphs [0013], [0302], [0304], [0306]) in order to allow a user to correct the treatment plan for root entanglement (refer to Paragraph [0306]).
Regarding claim 12, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine that the planned final position for the one or more teeth of the of the patient is unachievable at least in part due to the comparison of the current and planned position, wherein that comparison includes an evaluation of various clinical and positional parameters (refer to Paragraphs [0059], [0060], [0070], Fig. 9C; if the patient’s teeth are determined off track, the original treatment plan will be suspended, wherein the original treatment plan includes an initial final arrangement; the suspension of the original plan demonstrates that the initial final arrangement is not achievable or too difficult to achieve); however, Kitching is silent to that clinical parameter being the roots of the one or more teeth preventing the planned tooth movement, and/or determining that the roots of the one or more teeth preventing the planned tooth movement.
Sachdeva’2 discloses a system (100) configured for planning orthodontic treatment (refer to Paragraphs [0003], [0080]-[0082]) in the same field of endeavor. The computing device (10) includes the roots of the one or more teeth preventing the planned tooth movement in their orthodontic treatment plan (refer to Paragraphs [0302] [0306]), and further determine that roots of one or more teeth of the of the patient prevent a planned tooth movement (refer to Paragraphs [0302], [0304], [0306]; the determination that a root prevents planned tooth movement is equivalent to a determination by the computing unit that roots have collided, thereby obstructing further tooth movement; the treatment planning software identifies a tooth root abnormality such as tooth-roots entangled with each other).The clinical identification of root entanglement allows for treatment plan creation or modification to correct this abnormality (refer to Paragraph [0306]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining clinical parameters as taught by Kitching (refer to Paragraphs [0059], [0060], [0070], Fig. 9C) to include the roots of the one or more teeth preventing the planned tooth movement, and determining that the roots of the one or more teeth are preventing the planned tooth movement as taught by Sachdeva’2 (refer to Paragraphs [0302], [0304], [0306]) in order to allow a user to adjust the treatment plan to correct the root abnormality (refer to Paragraph [0306]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching et al. (US 20140335466 A1), herein referred to as Kitching, in view of Sachdeva et al. (US 20040197727 A1), herein referred to as Sachdeva’3.
Regarding claim 7, Kitching discloses the system (700) of claim 1, wherein the of the patient is a first one of an upper dental arch or a lower dental arch (refer to Paragraph [0031]; the patient’s upper (100) and lower jaw (101) are associated with the treatment plan) and wherein the computing device (computer of 700) is further configured to:
determine one or more clinical signs of a deviation from the planned condition of the of the patient based on the comparison (refer to Paragraph [0059]; various clinical and/or positional parameters can be examined and compared for determination as to whether the patient’s teeth are deviating from an expected arrangement); however, Kitching does not further disclose wherein the one or more clinical signs indicate that tooth movement of one or more teeth on the first one of the upper dental arch or the lower dental arch is blocked by one or more teeth on a second one of the upper dental arch or the lower dental arch.
Sachdeva’3 discloses a system (100) configured for making a comparison of the actual condition of a patient’s dental arch to a planned condition in the same field of endeavor (refer to Paragraphs [0049], [0053], [0226], [0228]; treatment evaluation of a treatment set-up against the patient’s response state is performed, wherein the response state is the current representation of the patient’s orthodontic state during treatment; the system (100) is configured for performing this evaluation via a processor (12)). Tools of a computing device (10) to evaluate clinical signs related to teeth colliding are described, wherein the one or more clinical signs indicate that tooth movement of one or more teeth on the first one of the upper dental arch or the lower dental arch is blocked by one or more teeth on a second one of the upper dental arch or the lower dental arch (refer to Paragraph [0317]; contacts between an upper arch and lower arch where collision would occur are in designated in red; the collision of two teeth, one on the upper arch and the second on a lower arch is equivalent to contact wherein the further movement by either tooth is blocked by the other tooth, due to the collision). This feature allows a user to evaluate collisions that prevent progression to a final tooth arrangement.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining clinical parameters of Kitching (refer to Paragraph [0059]) with clinical signs of arch collision as taught by Sachdeva’3 (refer to Paragraph [0317]) in order to allow a user to evaluate collisions that prevent progression to a final tooth arrangement.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching et al. (US 20140335466 A1), herein referred to as Kitching, in view of Imgrund et al. (US 20020150859 A1), herein referred to as Imgrund.
Regarding claim 9, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine one or more clinical signs of a deviation from the planned condition of the of the patient based on the comparison (refer to Paragraph [0059]; various clinical and/or positional parameters can be examined and compared for determination as to whether the patient’s teeth are deviating from an expected arrangement); however, Kitching does not further disclose a clinical sign including recession of gingival tissue.
Imgrund discloses a system (50) wherein the computing device (58) is configured for executing a method of evaluating a patient’s dentition for planning orthodontic treatment in the same field of endeavor (refer to Paragraphs [0003], [0059]). The computing device (58) is configured to evaluate clinical signs of a patient’s dentition at different points in time, comparing the tooth models to determine one or more clinical signs of deviation (refer to Paragraph [0076]; an initial patient scan is compared to a second scan and the tooth models are compared), wherein the one or more clinical signs comprise an observation that recession of gingival tissue has occurred (refer to Paragraph [0078]; the process of comparison includes gingival recession). This clinical sign is beneficial for diagnosing erosion from tooth brushing (refer to Paragraph [0078]) .
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining clinical parameters of Kitching (refer to Paragraph [0059]) to include gingival clinical signs as taught by Imgrund (refer to Paragraph [0078]) in order to allow a user to evaluate the occlusion of the actual state of the patient dentition.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching et al. (US 20140335466 A1), herein referred to as Kitching, in view of Chen (TW 201517883 A). All references to Chen refer to the provided translation.
Regarding claim 10, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine one or more clinical signs of a deviation from the planned condition of the of the patient (refer to Paragraph [0059]; various clinical and/or positional parameters can be examined and compared for determination as to whether the patient’s teeth are deviating from an expected arrangement); however, Kitching does not further disclose the clinical signs comprising an indication that a midline is not aligned with a face of the patient.
Chen discloses an orthodontic correction evaluation system in the same field of endeavor (refer to Abstract). After receiving a 3D model of the patient’s dentition (refer to paragraph 19) the orthodontic evaluation system evaluates multiple clinical signs (refer to paragraph 12), wherein the one or more clinical signs comprise an indication that a midline is not aligned with a face of the patient (refer to paragraph 22; the midline deviation calculation unit (100) is configured to obtain output a negative or positive value indicating which direction the facial midline is not aligned). The midline alignment assists in treatment planning (refer to paragraph 9).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining clinical parameters as taught by Kitching (refer to Paragraph [0059]) with an indication that a midline is not aligned with a patient’s face as taught by Chen (refer to paragraph 22) in order to allow a user to better plan an orthodontic treatment(refer to paragraph 9).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching et al. (US 20140335466 A1), herein referred to as Kitching, in view of Sporbert et al. (US 20050271996 A1), herein referred to as Sporbert.
Regarding claim 11, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine that the planned final position for the one or more teeth of the of the patient is unachievable at least in part due to the comparison of the current and planned position, wherein that comparison includes an evaluation of various clinical and positional parameters (refer to Paragraphs [0059], [0060], [0070], Fig. 9C; if the patient’s teeth are determined off track, the original treatment plan will be suspended, wherein the original treatment plan includes an initial final arrangement; the suspension of the original plan demonstrates that the initial final arrangement is not achievable or too difficult to achieve); however, Kitching is silent to that clinical parameter being interproximal reduction (IPR) that was not performed, and is further silent to the computing device being configured to determine interproximal reduction (IPR) that was not performed.
Sporbert discloses a system (100) for evaluation of treatment progress tracking in the same field of endeavor (refer to Paragraphs [0003], [0105], [0106]). The system (100) comprises a computing device (10), wherein the computing device (10) is configured to determine that the orthodontic treatment plan called for an amount of interproximal reduction (IPR),a clinical parameter, that was not performed (refer to Paragraphs [0326], [0327]; the determination that IPR was not performed is equivalent to a determination by the computing unit that the teeth are crowded, meaning the interproximal contact measurement is less than a desired value; the evaluation of the treatment plan includes measuring interproximal contacts and assigning a score based on that value, wherein that score equates to the acceptability of the interproximal distance). This evaluation criteria can be used for periodically monitoring the patient to plan corrective actions for the treatment (refer to Paragraph [0334]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining clinical parameters as taught by Kitching (refer to Paragraph [0059) with criteria for determining that IPR was not performed, and determining IPR was not performed as taught by Sporbert (refer to Paragraphs [0326], [0327]) in order to plan corrective actions for the treatment (refer to Paragraph [0334])..
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching et al. (US 20140335466 A1), herein referred to as Kitching, in view of Sachdeva et al. (US 6851949 B1), herein referred to as Sachdeva’4.
Regarding claim 13, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine that the planned final position for the one or more teeth of the of the patient is unachievable at least in part due to the comparison of the current and planned position, wherein that comparison includes an evaluation of various clinical and positional parameters (refer to Paragraphs [0059], [0060], [0070], Fig. 9C; if the patient’s teeth are determined off track, the original treatment plan will be suspended, wherein the original treatment plan includes an initial final arrangement; the suspension of the original plan demonstrates that the initial final arrangement is not achievable or too difficult to achieve); however, Kitching is silent to that clinical parameter being tooth extraction that was not performed, and is further silent to the computing device being configured to determine that tooth extraction was not performed.
Sachdeva’4 discloses a system (10) for generating a three-dimensional model of a desired orthodontic structure and analyzing the three-dimensional model to determine feasibility (refer to col. 3, lines 45-65 and Fig. 1). The system (10) further comprises a computing device (20) configured with a clinical parameter being tooth extraction that was not performed, and is further configured to determine that a tooth extraction was planned but was not performed (refer to col. 3 lines 39-40, col. 8, lines 30-37 and Figs. 5- 7; the determination that an extraction was not performed is equivalent to a determination that an extra tooth is present; an abnormal tooth is identified from a 3D model of the dentition and a determination is made as to whether the tooth is extra). A determination that an extra tooth is present allows for the computing device (20) to offer additional corrective treatment options and further determine if these treatments are acceptable (refer to col. 8, lines 52-64).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining clinical parameters as taught by Kitching (refer to Paragraph [0059]) with criteria for determining that tooth extraction was not performed as taught by Sachdeva’ 4 (refer to col. 3 lines 39-40, col. 8, lines 30-37 and Figs. 5- 7) in order to allow a user to plan corrective actions for the treatment (refer to col. 8, lines 52-64).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching et al. (US 20140335466 A1), herein referred to as Kitching, in view of Bergerson (US 20150342545 A1).
Regarding claim 18, Kitching discloses the system (700) of claim 1, wherein the computing device (computer of 700) is further configured to:
determine that the planned final position for the one or more teeth of the patient's dental arch is unachievable at least in part due to the comparison of the current and planned position, wherein that comparison includes an evaluation of various clinical and positional parameters (refer to Paragraphs [0059], [0060], [0070], Fig. 9C; if the patient’s teeth are determined off track, the original treatment plan will be suspended, wherein the original treatment plan includes an initial final arrangement; the suspension of the original plan demonstrates that the initial final arrangement is not achievable or too difficult to achieve); however, Kitching is silent to that clinical parameter being palatal expansion that was not performed, and is further silent to the computing device (computer of 700) being configured to determine that palatal expansion was not performed.
Bergersen discloses a system (10) for performing an orthodontic assessment of a patient in the same field of endeavor (refer to Paragraph [0001]). The system (10) comprises a computing device (20), wherein the computing device (20) is configured with a clinical parameter of palatal expansion that was not performed, and further configured to determine from a digital model of the patient’s dentition, that an amount of palatal expansion that was not performed (refer to Paragraphs [0222], [0226]; determination that palatal expansion has not been performed is equivalent to a determination by the computing unit (20) that a cross-bite exists, as cross-bite is a condition resolved by palatal expansion; the CPU (20) indicates the cross bite in the patient’s dentition for determining treatment ). Identification that palatal expansion is still required allows the computing unit (20) to plan corrective actions for treatment, such as specific appliances (refer to Paragraph [0237]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of determining clinical parameters as taught by Kitching (refer to Paragraph [0059]). with criteria for determining that palatal expansion was not performed as taught by Bergersen (refer to Paragraphs [0222], [0226]) in order to plan corrective actions for the treatment (refer to Paragraph [0237]).
.
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.
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Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11872102 B2 in view of Kitching et al. (US 20140335466 A1), herein referred to as Kitching. Any potential difference(s) between claims 1-2 of the instant application and the reference patent are obvious, as evidenced by Kitching. The differences between the claims are highlighted below by underlining all limitations that differ and will be addressed below, and italicizing additional limitations in the reference claims.
Instant Application 18393571
U.S. Patent 11872102 B2
1. A system comprising:
a computing device comprising a memory and a processor, the computing device configured to:
receive scan data of an actual condition of a of a patient at a stage of an orthodontic treatment plan;
make a comparison of the actual condition of the of the patient as depicted in the scan data to a planned condition of the of the patient for the stage of the orthodontic treatment plan;
determine, based on a result of the comparison, that a planned final position for one or more teeth of the of the patient is unachievable without corrective action;
determine a new final position for the one or more teeth of the of the patient; and
update the orthodontic treatment plan to replace the planned final position for the one or more teeth of the
cause one or more new orthodontic aligners associated with the updated orthodontic treatment plan to be manufactured, wherein the one or more new orthodontic aligners are manufactured based on one or more virtual three-dimensional (3D) models corresponding to the updated treatment plan.
2. The system of claim 1, wherein the computing device is further configured to:
generate the one or more virtual three-dimensional (3D) models associated with the one or more new orthodontic aligners to be manufactured in accordance with the updated orthodontic treatment plan.
16. A system comprising:
an intraoral scanner to generate scan data of an actual condition of a patient's dental arch after an orthodontic treatment plan has begun; and
a computing device comprising a memory and a processor, the computing device to:
receive the scan data of the actual condition of the patient's dental arch at a stage of the orthodontic treatment plan;
make a comparison of the actual condition of the patient's dental arch as depicted in the scan data to a planned condition of the patient's dental arch for the stage of the orthodontic treatment plan;
determine an updated orthodontic treatment plan based on one or more differences between the actual condition of the patient's dental arch and the planned condition of the patient's dental arch determined from the comparison; and
generate one or more three-dimensional (3D) models for one or more new orthodontic aligners in accordance with the updated orthodontic treatment plan.
20. The system of claim 16, wherein the computing device is further to:
determine that a planned final condition of the patient's dental arch is not achievable based on a result of the comparison,
wherein the updated orthodontic treatment plan at least one of
a) enables achievement of the planned final condition of the patient's dental arch or
b) modifies the planned final position of the patient's dental arch.
Claim 1 differs from claim 20 of the reference patent in by the following:
Claim 20 of the reference patent does not recite the step of causing “one or more new orthodontic aligners associated with the updated orthodontic treatment plan to be manufactured, wherein the one or more new orthodontic aligners are manufactured based on one or more virtual three-dimensional (3D) models corresponding to the updated treatment plan”.
However, Kitching teaches a system (700) with a computing device (computer of 700) configured to cause one or more orthodontic aligners associated with the updated orthodontic treatment plan to be manufactured, wherein the one or more orthodontic aligners are manufactured based on one or more virtual three-dimensional (3D) models corresponding to the updated treatment plan(refer to Paragraphs [0041], [0046], [0074]; dental appliances are fabricated based on data set from a treatment plan, which includes the modified or revised treatment plans; the data set includes models of the teeth generated by 3-dimensional treatment planning software). Fabricating the updated aligners based on treatment tracking prevents the problem of continued treatment with previously designed, batch fabricated aligners that no longer fit (refer to Paragraphs [0006], [0035]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of claim 20 of the reference patent with the manufacturing of the updated aligner as taught by Kitching in order to prevent continued treatment with previously designed, batch fabricated aligners that no longer fit (refer to Paragraphs [0006], [0035]).
Claim 20 of the reference patent recites unachievable without corrective action, rather than difficult to achieve. However, “unachievable without corrective action” anticipates the term “difficult to achieve”; under the broadest reasonable interpretation, a dental practitioner can determine a case too difficult to achieve is not achievable without corrective action.
Claim 20 of the reference patent recites “modified the planned final position”, rather than “determine a new final position for the one or more teeth”. These terms are equivalent, as modification of a final tooth position includes a new final position for the teeth per Applicant’s specification (refer to page 4, lines 24-25).
Claim 20 of the reference patent recites “determine an updated orthodontic treatment plan based on one or more differences between the actual condition of the patient's dental arch and the planned condition of the patient's dental arch determined from the comparison”, rather than “update the orthodontic treatment plan to replace the planned final position for the one or more teeth of the of the patient with the new final position for the one or more teeth of the of the patient.” An updated treatment plan, per Applicant’s specification includes replacing the final position (refer to page 26, lines 3-6).
Claim 20 of the reference patent includes all the limitations of claim 2, while also reciting further limitations.
Response to Arguments
The outstanding drawing objection of Fig. 5 is withdrawn in view of the newly submitted drawing amendment.
The outstanding 35 USC 101 rejections are withdrawn in view of the newly submitted claim amendments. Examiner notes that although the rejection is withdrawn, the pending claim objections are drawn to clarifying the amended language in response to the 101 rejection.
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
In response to Applicant's arguments on the double patenting rejection, the amended claim language has been rejected using an obviousness NSDP rejection, as demonstrated above.
In response to Applicant’s arguments that the amended claims are not anticipated or obvious over the previously disclosed prior art, Examiner points to the above rejection of all claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ADRIENA J WEBB LYTTLE/ Examiner, Art Unit 3772
/EDELMIRA BOSQUES/ Supervisory Patent Examiner, Art Unit 3772