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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No(s). EP21183816.4 and EP21183818.0, filed on 07/05/2021.
For the purpose of examination, the priority date for claims 1-6, 9 is 07/05/2021.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Claim 1
Lines 2-4 are missing the original claim language of “force measurement of the aligner on the teeth”. This language should be striked out for the amended claim.
Line 6 has a typo, “different of the teeth”. Examiner recommends changing this to “different teeth” in line with language of claim 5.
Claim 2
Line 8 has a typo, “sufficient of the forces to the teeth”.
Line 9, Examiner recommends modifying this line to, “determining based upon the monitoring of the forces”.
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 2 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.
In the last line of claim 2, Applicant recites the limitation of providing a new aligner. The specification does not detail providing or providing for a new aligner, rather only determining the time to change to a new aligner (refer to page 1, line 29 of the specification). Examiner understands that this limitation was added to clearly indicate that the aligner is part of the method claim. To maintain the aligner being apart of the method claim, Examiner recommends amending the claim language of lines 1-2 to state the following:
A method of force measurement of the aligner according to claim 1, comprising:
providing the aligner of claim 1
providing the force/displacement curves…
Information Disclosure Statement
The information disclosure statement filed 12/01/2025 has been considered; however, only the provided English abstracts of the foreign references have been considered (with the exception of WO2023280770 A1, and WO 2023280769 A1, for which the complete translations were provided).
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) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fok et al. (US 20230131264 A1), herein referred to as Fok.
Regarding claim 1, Fok discloses an aligner (10) for use in the treatment of malocclusions/misalignments based on measurement of forces exerted on the teeth by the aligner (refer to Paragraphs [0034], [0046]; based on the mechanical properties of the aligner (10), an orthodontic recommendation is made for the aligner (10); the evaluated mechanical properties include calculation of force using a computational model), said aligner having an initial state prior to application of forces due to wearing of the aligner (refer to Paragraphs [0030], [0036]; the orthodontic aligner (10) has an initial state captured in a first image of an aligner, prior to the user wearing the aligner (10))
at least two referencing features (12) are located on the aligner (10) in the initial state, the at least two referencing features (12) associated with different of the teeth (refer to Paragraphs [0030], [0035] and Fig. 1; Examiner understands this limitation as “associated with different teeth”; the orthodontic aligner (10) comprises a plurality of speckles on different parts of the aligner (10) corresponding to different teeth that are acquired in a first image, demonstrating the speckles (12) are present at an initial state) and configured for tracking a displacement between a first of the at least two referencing features (12) and a second of the at least two referencing features (12) during the application of the forces exerted on the teeth due to the wearing of the aligner (10) (refer to Paragraphs [0026], [0035], [0036] and Fig. 1; the speckles (12) are used to form a full-field displacement distribution by comparing different image sets of the same speckled segments to form displacement vectors; each displacement vector represents how the speckles (12) have shifted while the aligner is worn, relative to the initial surface distribution; therefore, the aligner (10) is capable of, and configured for tracking a displacement between the at least two referencing features (12));
said at least two referencing features (12) being discrete optical or topographical features (refer to Paragraph [0026]; the plurality of speckles (12) can have any optical characteristics suitable for digital image correlation);
wherein the displacement between the first of the at least two referencing features (12) and the second of the at least two referencing features (12) is used to calculate the forces exerted on the teeth by converting the displacement using force/displacement curves (refer to Paragraphs [0026], [0035], [0036] and Fig. 1; Examiner understands this limitation as function or intended use; when the cited prior art teaches all of the positively recited structure of the claimed apparatus (two referencing features, 12), it will be held that the prior art apparatus is capable of performing all of the claimed functional limitations of the claimed apparatus. The courts have held that: (1) "apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990), and (2) a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). MPEP § 2114.)
Fok does not disclose the size of the at least two referencing features (12) as being at least 10 micrometers in size; however, Fok does teach that the referencing features are configured to be detected by a camera of an intraoral imaging device (refer to Paragraph [0024]; the plurality of speckles are adapted for digital image correlation measurements) and can be large enough to be visible to the naked eye (paragraph 0026).
Further, Applicant’s disclosure does not disclose any benefit or advantage associated with the referencing features being of 10 µm, stating that the optical features can be of any size from 10 µm to 1000 µm (refer to page 2, lines 18-20 of the Specification). The courts have held the following: In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP § 2144.04-IV-A.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the size of the referencing features (12) to be 10 µm, to be accurately detected.
Claim(s) 2, 3, 5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fok et al. (US 20230131264 A1), herein referred to as Fok in view of Shojaei et al. (US 20210196429 A1), herein referred to as Shojaei.
Regarding claim 2, Fok discloses a method of force measurement of the aligner (10) according to claim 1 (100, 200), (refer to Paragraphs [0030], [0032], [0043]; two methods (100, 200) are disclosed for performing digital image correlation, with examples of performing the method including evaluation of the forces and moments on each tooth) comprising the steps of:
determining [[a]] the displacement of the at least two referencing features (12) from each other relative to the initial state due to the application of forces while the aligner (2) is being worn by the a patient using an image acquired by [[a]] the camera
calculating the forces acting on the teeth aligner (refer to Paragraph [0030]; the initial geometry of the aligner is known from the initial image in processing block 102);
monitoring the forces acting on the teeth for clinical treatment to determine an effectiveness of the aligner (10) to supply sufficient of the forces to the teeth (refer to Paragraph [0044]; the forces induced on the teeth are used to study the effectiveness of the aligner design in realizing the desired load performance);
determining based upon the monitoring the forces a time to change to a new aligner (10) (refer to Paragraph [0034], [0046]; based on the change in the calculated mechanical properties, which includes forces on the teeth, an orthodontic recommendation suggesting that the orthodontic aligner be replaced); and
Fok does not disclose being provided with the force/displacement curves providing for the new aligner.
Shojaei discloses a method of verifying the forces applied by the appliance to a patient’s teeth in the same field of endeavor (refer to Paragraph [0032]). The method comprises the steps of providing the force/displacement curves of the plastic of the aligner in an initial state (refer to Paragraphs [0023], [0057], [0063] and Fig. 6B; at block 1032, a 3D force-displacement model is provided for the polymer aligner at the 2nd stage prior to the aligner being manufactured and applied to the patient’s teeth, thereby being in an initial state; a 3D force-displacement model is equivalent to a force-displacement curve that is mapped in 3-dimensions; the 3D force-displacement model represents the plastic of the aligner, as it is obtained from a stiffness matrix of the aligner based on the aligner material properties and by definition a stiffness matrix links force to displacement for specific points of a structure) and calculating forces acting on a tooth by converting the determined displacement via the provided force/displacement curve (refer to Paragraphs [0057], [0064]-[0066], [0074] and Figs. 5, 6B; at block 1040, the displacement field generated at block 1020 is used with the resultant forces determined from the 3D force-displacement model in block 1033 to evaluate the magnitude and direction of force between the aligner and the patient’s teeth; alternative force validation method, 1300, also uses this method, further elaborating that the calculated forces are applied forces to the patient’s teeth by the aligner, used for comparison to threshold values of moving teeth, tooth damage, and excessive patient pain). Further, the appliance is provided for (refer to Paragraph [0058]; at block 940, the orthodontic appliance is directly fabricated).
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 calculating forces on a patient’s tooth as taught by Fok with the steps of providing force/displacement models and calculating the applied forces on the tooth from these models as taught by Shojaei, as this is a known method in the art of performing force measurement to determine if the forces applied to a patient’s teeth by an aligner will be sufficient for moving teeth, the objective of Applicant’s device (refer to Paragraphs [0073]-[0074]).
Regarding claim 3, Fok discloses the method of claim 2, further comprising the step of:
determining the displacement of the at least two referencing features (12) from each other due to the application of the forces from a mouth of the patient using a second image acquired by the camera (refer to Paragraphs [0030], [0035], [0036], [0038], [0039]; a digital image of the aligner is taken prior to being worn in processing block 102, and compared to a digital image of the aligner after being worn for a period of time in processing block 106, wherein that second image includes a freestanding image of the aligner (IMF); per Applicant’s Specification, the displacement is the measurement of how the referencing features shift on the aligner surface during force application (refer to page 4, lines 26-27); the digital image correlation performed in processing block 106, is equivalent to Applicant’s process of determining displacement, as this method creates a full-field displacement distribution where each displacement vector represents how each speckle (12) shifts on the aligner (10) surface relative to the initial surface distribution);
Regarding claim 4, Fok discloses a
determining the displacement of the at least two referencing features (12) from each other relative to the initial state due to the application of forces while the aligner (2) is being worn by the a patient using an image acquired by [[a]]the camera or other means (108) (refer to Paragraphs [0030], [0035], [0036], [0038], [0039]; a digital image of the aligner is taken prior to being worn in processing block 102, and compared to a digital image of the aligner after being worn for a period of time in processing block 106, wherein that second image includes an image of the aligner while being worn by the patient (IMP); per Applicant’s Specification, the displacement is the measurement of how the referencing features shift on the aligner surface during force application (refer to page 4, lines 26-27); the digital image correlation performed in processing block 106, is equivalent to Applicant’s process of determining displacement, as this method creates a full-field displacement distribution where each displacement vector represents how each speckle (12) shifts on the aligner (10) surface relative to the initial surface distribution);
calculating the forces acting on the teeth aligner (refer to Paragraph [0030]; the initial geometry of the aligner is known from the initial image in processing block 102);
monitoring the forces acting on the teeth for clinical treatment to determine an effectiveness of the aligner (10) to supply sufficient of the forces to the teeth (refer to Paragraph [0044]; the forces induced on the teeth are used to study the effectiveness of the aligner design in realizing the desired load performance);
determining based upon the monitoring the forces a time to change to a new aligner (10) (refer to Paragraph [0034], [0046]; based on the change in the calculated mechanical properties, which includes forces on the teeth, an orthodontic recommendation suggesting that the orthodontic aligner be replaced); and
Fok does not disclose a computer readable storage medium for performing the method steps of claim 2.
Shojaei discloses a computer-assisted intraoral imaging device (1500) in the same field of endeavor for executing force validation of an aligner (refer to Paragraphs [0032], [0034], [0048], [0084], [0089], Fig. 12; based on Applicant’s specification, the computer-assisted intraoral imaging device comprises both a camera and computer, wherein the computer executes the program (refer to page 5, lines 16-20); the camera (1525) is disclosed as part of the treatment plan gathering device (132) that obtains images of the intraoral cavity and further disclosed as part of the computer-based intraoral imaging device (1500), which is a computer; forces applied by the aligner appliance are verified as part of the design of the force system, with the data processing system (1500) executing this method of force validation). The force-validation steps include determining a displacement field, similar to the field computed by Fok (refer to Paragraph [0073] and Fig. 3) and calculating the forces acting on the tooth, also similar to the method of Fok et al. (refer to Paragraph [0074]). Both of these steps are performed by instructions on a computer-readable storage medium (refer to Paragraphs [0089], [0091], [0093] and Fig. 12; memory subsystem (1508) comprises computer readable memory for storage of fixed instruction in executing the disclosed methods and processes during program execution by the computer (1500)). Computer-readable storage mediums are beneficial for automating steps that may traditionally be performed manually.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have implemented the method steps of Fok on a computer readable storage medium as taught by Shojaei to automate the process of force calculation.
Further, Fok et al. does not disclose of being provided with the force/displacement curves providing for the new aligner on a computer storage medium.
Shojaei et al. discloses a computer-assisted intraoral imaging device (1500) in the same field of endeavor for executing force validation of an aligner (refer to Paragraphs [0032], [0034], [0048], [0084], [0089], Fig. 12; based on Applicant’s specification, the computer-assisted intraoral imaging device comprises both a camera and computer, wherein the computer executes the program (refer to page 5, lines 16-20); the camera (1525) is disclosed as part of the treatment plan gathering device (132) that obtains images of the intraoral cavity and further disclosed as part of the computer-based intraoral imaging device (1500), which is a computer; forces applied by the aligner appliance are verified as part of the design of the force system, with the data processing system (1500) executing this method of force validation). The method comprises the steps of providing the force/displacement curves of the plastic of the aligner in an initial state (refer to Paragraphs [0023], [0057], [0063] and Fig. 6B; at block 1032, a 3D force-displacement model is provided for the polymer aligner at the 2nd stage prior to the aligner being manufactured and applied to the patient’s teeth, thereby being in an initial state; a 3D force-displacement model is equivalent to a force-displacement curve that is mapped in 3-dimensions; the 3D force-displacement model represents the plastic of the aligner, as it is obtained from a stiffness matrix of the aligner based on the aligner material properties and by definition a stiffness matrix links force to displacement for specific points of a structure) and calculating forces acting on a tooth by converting the determined displacement via the provided force/displacement curve (refer to Paragraphs [0057], [0064]-[0066], [0074] and Figs. 5, 6B; at block 1040, the displacement field generated at block 1020 is used with the resultant forces determined from the 3D force-displacement model in block 1033 to evaluate the magnitude and direction of force between the aligner and the patient’s teeth; alternative force validation method, 1300, also uses this method, further elaborating that the calculated forces are applied forces to the patient’s teeth by the aligner, used for comparison to threshold values of moving teeth, tooth damage, and excessive patient pain). The computer-assisted intraoral imaging device (1500) comprises a non-transitory computer-readable storage medium (1508) storing a program, comprising instructions which, when executed by a computer-assisted intraoral imaging device (1520), causes the computer-assisted intraoral imaging device (1500) to perform the force validation method as described above (refer to Paragraph [0091] and Fig. 12; memory subsystem (1508) comprises computer readable memory for storage of fixed instruction during program execution by the computer (1500)). Further, the appliance is provided for (refer to Paragraph [0058]; at block 940, the orthodontic appliance is directly fabricated via provided instructions).
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 calculating forces as taught by Fok to include the steps of providing force/displacement models and calculating the applied forces on the tooth from these models via instructions on a computer-readable storage medium as taught by Shojaei, as implementing these method steps by a computer storage medium is known in the art (refer to Paragraphs [0073]-[0074]).
Regarding claim 5, Fok discloses a system for force measurement
an aligner (10) including at least two referencing features (12) located on the aligner in an initial state prior to application of forces due to wearing of the aligner (refer to Paragraphs [0030], [0035] and Fig. 1; the orthodontic aligner (10) comprises a plurality of speckles that are acquired in a first image, demonstrating the speckles (12) are present at an initial state), wherein the at least two references features (12) are associated with different teeth (refer to Fig.1; the plurality of speckles are shown on different parts of the aligner (10) corresponding to different teeth), wherein the at least two referencing features (12) are discrete optical or topographical features (refer to Paragraph [0026]; the plurality of speckles (12) can have any optical characteristics suitable for digital image correlation);
a processor (refer to Paragraphs [0041]-[0042]; StrainMaster by LaVision Inc. is used for the digital image correlation process; it is inherent that a device used for processing image data comprises a processor for performing the method); and
a camera (refer to Paragraphs [0041]-[0042]; StrainMaster by LaVision Inc. is used for the digital image correlation process, which includes acquiring images; it is inherent that a device used for acquiring digital images of an aligner in the mouth of a patient also comprises a camera capable of obtaining an intraoral image);
wherein the processor is configured to (refer to Paragraphs [0041]-[0042]; StrainMaster by LaVision Inc., which contains a processor, performs the disclosed method of digital image correlation):
determine a displacement of the at least two referencing features (12) from each other relative to the initial state due to the application of forces while the aligner (2) is being worn by the a patient using an image acquired by [[a]] the camera or other means (108) (refer to Paragraphs [0030], [0035], [0036], [0038], [0039]; a digital image of the aligner is taken prior to being worn in processing block 102, and compared to a digital image of the aligner after being worn for a period of time in processing block 106, wherein that second image includes an image of the aligner while being worn by the patient (IMP); per Applicant’s Specification, the displacement is the measurement of how the referencing features shift on the aligner surface during force application (refer to page 4, lines 26-27); the digital image correlation performed in processing block 106, is equivalent to Applicant’s process of determining displacement, as this method creates a full-field displacement distribution where each displacement vector represents how each speckle (12) shifts on the aligner (10) surface relative to the initial surface distribution);and
calculating forces acting on the teeth via the known geometry of the aligner
Fok does not disclose the size of the at least two referencing features (12) as being at least 10 micrometers in size; however, Fok does teach that the referencing features are configured to be detected by a camera of an intraoral imaging device (refer to Paragraph [0024]; the plurality of speckles are adapted for digital image correlation measurements) and can be large enough to be visible to the naked eye (paragraph 0026).
Further, Applicant’s disclosure does not disclose any benefit or advantage associated with the referencing features being of (10 µm), stating that the optical features can be of any size from 10 µm to 1000 µm (refer to page 2, lines 18-20 of the Specification). The courts have held the following: In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP § 2144.04-IV-A.
Fok does not disclose a processor configured to be provided with a force/displacement curve or convert the determined displacement via the provided force/displacement curve.
Shojaei et al. discloses a processor (1502) configured to perform a method of verifying the forces applied by the appliance to a patient’s teeth in the same field of endeavor (refer to Paragraphs [0032], [0089]; the processor (1502) is part of the data processing system (1500), used for executing the disclosed methods and processes). The method comprises the steps of providing the force/displacement curves of the plastic of the aligner in an initial state (refer to Paragraphs [0023], [0057], [0063] and Fig. 6B; at block 1032, a 3D force-displacement model is provided for the polymer aligner at the 2nd stage prior to the aligner being manufactured and applied to the patient’s teeth, thereby being in an initial state; a 3D force-displacement model is equivalent to a force-displacement curve that is mapped in 3-dimensions; the 3D force-displacement model represents the plastic of the aligner, as it is obtained from a stiffness matrix of the aligner based on the aligner material properties and by definition a stiffness matrix links force to displacement for specific points of a structure) and calculating forces acting on a tooth by converting the determined displacement via the provided force/displacement curve (refer to Paragraphs [0057], [0064]-[0066], [0074] and Figs. 5, 6B; at block 1040, the displacement field generated at block 1020 is used with the resultant forces determined from the 3D force-displacement model in block 1033 to evaluate the magnitude and direction of force between the aligner and the patient’s teeth; alternative force validation method, 1300, also uses this method, further elaborating that the calculated forces are applied forces to the patient’s teeth by the aligner, used for comparison to threshold values of moving teeth, tooth damage, and excessive patient pain).
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 processing system of calculating forces on a patient’s tooth as taught by Fok with the steps of providing force/displacement models and calculating the applied forces on the tooth from these models as taught by Shojaei as this is a known method in the art of performing force measurement to determine if the forces applied to a patient’s teeth by an aligner will be sufficient for moving teeth, the objective of Applicant’s device (refer to Paragraphs [0073]-[0074]).
(New) Regarding claim 9, Fok and Shojaei disclose the system according to claim 5, wherein the camera is a component of an intraoral imaging device (refer to Paragraphs [0041]-[0042]; StrainMaster by LaVision Inc. is used for the digital image correlation process and acquiring the digital images used in the process; it is inherent that a device used for acquiring digital images of an aligner in the mouth of a patient also comprises a camera capable of obtaining an intraoral image); Fok is silent to the system including an associated display.
Shojaei further discloses wherein a camera (1525) is a component of a system (1500) that includes an associated display (1518) to view the associated processes (refer to Paragraphs [0089], [0090], Fig. 15; the user interface input/output devices (1518) include displays).
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 Fok with a display (1518) as taught by Shojaei in order to easily display the methods and processes performed (refer to Paragraph [0089]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fok et al. (US 20230131264 A1), herein referred to as Fok, and Shojaei et al. (US 20210196429 A1), herein referred to as Shojaei, as applied to claim 5 above, and further in view of Kounga et al. (US 20210259806 A1), herein referred to as Kounga .
Regarding claim 6, the combination of Fok and Shojaei discloses the system according to claim 5, further comprising:
a software application (refer to Paragraphs [0041]-[0042]; StrainMaster by LaVision Inc., which contains a processor, performs the disclosed method of digital image correlation; it is inherent that a processor performing analysis of images requires software to do so).
Fok et al. does not disclose the system further comprising a mobile phone having the camera, a display and a software application configured for visualization of results data from the processor on the display.
Kounga discloses a process for assessing stress relaxation for a dental arch for monitoring orthodontic treatment (refer to Abstract and Paragraph [0001]). The system for monitoring the patient’s orthodontic treatment comprises an orthodontic appliance and mobile phone having a camera and a display (refer to Paragraphs [0001], [0023], [0027]; the orthodontic device is paired with a software app via a smartphone for monitoring treatment via image acquisition by the built in camera in the smartphone; by definition (Oxford Languages), a smartphone has a touchscreen interface or display) and a software application configured for visualization of results data from the processor on the display (refer to Paragraphs [0091], [0093]; the device driven by the computer program logic is a smartphone; the system's program logic, when executed by a processor, causes the device to display the results of the image comparison for monitoring an orthodontic treatment). It is advantageous to use a smartphone to provide mobile monitoring of the patient (refer to Paragraph [0023]).
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 Fok and Shojaei with a mobile phone as taught by Kounga in order to easily acquire images for measuring tooth displacement using an image comparison tool (refer to Paragraphs [0023], [0029], [0032]).
Response to Arguments
The outstanding drawing objections are withdrawn in view of the newly submitted replacement drawings.
The outstanding specification objections are withdrawn in view of the newly submitted specification.
The outstanding claim objections of claims 1-3, 5, and 8 are withdrawn in view of the newly submitted claim amendments.
The outstanding 35 U.S.C. 112(b) rejections of claims 1-6, 8 are withdrawn in view of the newly submitted claim amendments.
The outstanding 35 U.S.C. 101 rejection of claims 2-4 is withdrawn in view of the claim amendments, as such, the arguments are moot; however, Examiner notes the recommendation above of modifying the language of claim 2.
Regarding the arguments presented for amended claim 1 overcoming the current prior art of record:
The referencing features being associated with different teeth is met by Fok, as detailed in the above rejection, as the plurality of speckles (12) are distributed across the aligner (10), with the aligner (10) including multiple cavities corresponding to a user’s teeth (refer to Paragraphs [0030], [0035] and Fig. 1).
The topographical features (12) are also disclosed by Fok and are configured to be detected by a camera (refer to Paragraph [0026]), with the size of the topographical features also rejected under 35 U.S.C. 103, , Applicant’s disclosure does not disclose any benefit or advantage associated with the referencing features being of 10 µm (see MPEP § 2144.04-IV-A and rejection above).
The limitations added to claim 1 for the displacement measurement (“at least two referencing features…configured for tracking a displacement between a first of the at least two referencing features and a second of the at least two referencing features”; “wherein the displacement between the first of the at least two referencing features and the second of the at least two referencing features is used to calculate the forces…”) are functional limitations. As claim 1 is an apparatus claim, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Fok discloses “at least two referencing features associated with different [of the] teeth”, which is the required structure to perform the intended use.
The above reasoning follows for the limitation, “an aligner for use in the treatment of malocclusions/misalignments based on force measurement”. This limitation also describes the intended use of the aligner.
In response to the argument that Fok’s disclosure is not drawn to the same purpose of Applicant’s device, Fok explicitly discloses using a displacement distribution to measure strain and calculate forces exerted on each tooth (refer to Paragraphs [0035], [0046]), for orthodontic evaluation and treatment (refer to Paragraphs [0034], [0036]).
Of note, the use of the terminology “at least two” means that any number of referencing features greater than two can be used to perform the claimed method. Examiner recommends Applicant amend the claim language to limit the number and placement of the referencing features to clearly depict “the discrete, strategically positioned referencing features” (Remarks, page 9, last paragraph).
Regarding the arguments on the technical distinction between Fok and Applicant’s device(s) and method, the language of the claims does not assert this distinction. The claims are given their broadest reasonable interpretation in view of the specification; however, the specification is not read into the claims. Further, the purpose of Fok’s method, is the same purpose of Applicant’s device, evaluation of a dental aligner before and after use for orthodontic treatment recommendations based on force measurement (refer to Paragraphs [0034]-[0036], [0046]).
In response to the arguments against Shojaei, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, Applicant’s claims do not state that the force/displacement curves are a physical measurement system, which are the limitations referenced in the rejection by Shojaei.
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