DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “means for probing” in claim 191. In light of the disclosure, it appears that the “means for probing” is a “force probe”.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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) 171-176, 179, 181, 183-184, 189, 192-193 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani et al. (US 2019/0231477 A1), in view of Kopelman et al. (US2019/0099129A1), Liu et al. (NPL, (2020); Application of FRET Biosensors in Mechanobiology and Mechanopharmacological Screening; Frontiers in Bioengineering and Biotechnology; Vol. 8. DOI=10.3389/fbioe.2020.595497), and Swager et al. (US8,158,437 B2), and further as evidenced by Hamner et al. (US 2004/0091695).
Regarding claim 171, Shanjani et al. teaches an orthodontic appliance (abstract) comprising:
A shell comprising a polymeric material ([0038]), wherein the shell comprises a plurality of tooth receiving cavities (see Figures); and
a force probe incorporated into the polymeric material for detecting a force applied to the orthodontic appliance ([0077], [0105-0106]); the appliance may have sensors that can measure force, stress/strain or other parameters of force to determine the state of the appliance and sensors are positioned within the appliance).
Shanjani et al. teaches the sensor may be an optical sensor, such as sensor 1008, that may be used to detect movement and/or position of one or more regions of the apparatus relative to other regions ([0106]) and it may include an emitter and a detector ([0124]).
Shanjani et al. is silent to wherein the force probe: when in an unstrained configuration comprises a first emission spectrum; and when in a strained configuration comprises a second emission spectrum, wherein the first emission spectrum and the second emission spectrum are distinct from one another, wherein a transition between the unstrained configuration and the strained configuration occurs when the force is applied to the orthodontic appliance.
Kopelman et al. teaches a device in the same field of endeavor of orthodontic appliances (abstract). Kopelman teaches the device may be an orthodontic appliance ([0083]) and may be made from a polymeric material ([0121]). The appliance has a biosensor (107) that may be formed with or connected integrally with the appliance ([0056]) and may be an optical sensor such as a florescence sensor such as FRET ([0014]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani to include a FRET force probe, such that it is a type of optical sensing technique that can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces.
Liu et al. teaches force probes such as FRET probes are commonly used for mechanical testing of strain in mechanobiology (Mechanical force-based FRET biosensors pp. 5). FRET biosensors function by having a donor and an acceptor connected by a flexible linker and the distance between the donor and acceptor is analyzed to directly quantify and detect the force-induced effects (Mechanical force-based FRET biosensors pp. 5). In other words, two fluorophores are coupled, one a donor that emits energy the other an acceptor that absorbs the energy emitted by the first fluorophore, and the spectral overlap between the emission spectrum of the donor and the excitation spectrum of the acceptor is observed, such that the distance between the two fluorophores is calculated and analyzed to reflect dynamic behavior due to the applied forces (FRET, pp. 2).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani and Kopelman to have the FRET force probe similar to Luiu’s, such that it can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces. Having a FRET biosensor in an orthodontic mouthpiece, such as the aligner of Shanjani, would include two fluorophores, each having an emission spectrum, one being emitted and one being absorbed as the forces are applied on the teeth, and the distance between the two analyzed.
Shanjani does not specifically teach the force probe comprises a molecule coupled to the polymeric material via electrostatic interaction or hydrogen bonding.
Swager et al. teaches devices and methods in the analogous art of polymeric materials and modulating properties of a polymeric material using optics (abstract). Swager teaches the method involves using fluorescence resonance energy transfer or FRET, which refers to the transfer of excitation energy from an excited State species (i.e., FRET donor) to an acceptor species (i.e., FRET acceptor), wherein an emission is observed from the acceptor species (Col. 5 l. 14-19). Swager teaches the interaction between the polymer and the analyte may comprise, for example, electrostatic interactions, binding interactions, redox reactions (e.g., reduction, oxidation), other chemical reactions, and the like. In some cases, the analyte may be an electron acceptor and the luminescent polymer may be an electron donor (Col. 3 l. 61-67).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have interaction between the polymer and the force probe be an electrostatic interaction, as taught by Swager, such that electrostatic interactions are one of known types of interactions between a polymeric material and a sensor/probe that may be used in a FRET system.
Moreover, the probe/sensor of the prior art must be bonded to another structure for the force to be applied to the donor and the acceptor of the FRET sensor in order for it to be pulled away, since FRET reflects proximity of two structures/ends/molecules. The claimed types of bonds and interactions are well known bonds.
Hamner teaches a polymeric material may be a part of a system that undergoes fluorescence resonance energy transfer (FRET) ([0008], [0021]) and may include probes in its chain to measure deformation when subject to pressure ([0008]) and the photoreactive FRET system is copolymerized with the polymer during polymer synthesis such that the elastomeric properties can be reflected by the FRET when the pressure is increased or lowered ([0025]). In FRET, the intermolecular distances required for FRET are in the order of 20 to 60 A, which is advantageous for probing movements of macro molecules. The energy transfer in FRET takes place without the emission and reabsorption of photons, and is solely the result of dipole-dipole interactions between donors and acceptors ([0021]). This reference provides one example of a FRET probe incorporated in a polymeric material. Both the acceptor and donor of the FRET must be bonded to the polymeric material in order to reflect behavior due to a load on the material. Therefore, it would further be obvious that the modified device includes molecules between the polymer and the probe that yield said electrostatic interaction, since each structure comprises molecules such that when bonded, they will result in the interaction reaction.
Regarding claim 172, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 171 (see rejection above). Shanjani et al. teaches wherein the force comprises a mechanical force comprising application of the orthodontic appliance to a patient's teeth (the device is an aligner for moving teeth orthodontically to correct tooth positions and so the force being applied on the tooth/teeth is a mechanical force).
Regarding claim 173, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 171 (see rejection above). Liu et al. teaches wherein the molecule comprises a detectable fluorophore having an emission spectrum (FRET, pp. 2; the force probe is a FRET biosensor comprising a first donor fluorophore that emits fluorescent energy).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani to include a FRET force probe, such that it is a type of optical sensing technique that can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces. Having a FRET biosensor in an orthodontic mouthpiece, such as the aligner of Shanjani, would include two fluorophores, each having an emission spectrum, one being emitted and one being absorbed as the forces are applied on the teeth, and the distance between the two analyzed.
Regarding claim 174, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 173 (see rejection above). Liu et al. teaches each fluorophore responds to an energy emission (Mechanical force-based FRET biosensors pp. 5). The combination teaches wherein the detectable fluorophore has a first detectable emission responsive to a first contact force, and a second detectable emission responsive to a second contact force since the emission would be a result of each corresponding force applied.
It would have been obvious to one having ordinary skill in the art that the fluorophore reacts to an initial force applied by the device by emitting energy as a first emission and a second emission corresponding to a second force applied by the device.
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani to include a FRET force probe, such that it is a type of optical sensing technique that can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces. Having a FRET biosensor in an orthodontic mouthpiece, such as the aligner of Shanjani, would include two fluorophores, each having an emission spectrum, one being emitted and one being absorbed as the forces are applied on the teeth, and the distance between the two analyzed.
Regarding claim 175, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 174 (see rejection above). The combination teaches wherein a transition between the first detectable emission and the second detectable emission occurs when a mechanical force is applied to the orthodontic appliance (the distance between the two fluorophore emissions is what is analyzed and those fluorophores emit the energy in response to the forces applied, which in this case would be forces applied to the orthodontic appliance).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani to include a FRET force probe, such that it is a type of optical sensing technique that can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces. Having a FRET biosensor in an orthodontic mouthpiece, such as the aligner of Shanjani, would include two fluorophores, each having an emission spectrum, one being emitted and one being absorbed as the forces are applied on the teeth, and the distance between the two analyzed.
Regarding claim 176, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 172 (see rejection above). Shanjani et al. teaches wherein the orthodontic appliance comprises a localized region (see Figs. 5A-8; the region where the sensor is located), the localized region comprising: the force probe (see Figs. 5A-8); at least some of the polymeric material (the material of the appliance in that region); and an area less than 100 nm in any direction from the force probe (the regions directly touching and around the force probe/sensor).
Regarding claim 179, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 173 (see rejection above). Liu et al. teaches wherein the molecule further comprises a photon absorber (Mechanical force-based FRET biosensors pp. 5 and FRET, pp. 2; the acceptor/receptor fluorophore is a photon absorber as it absorbs photons from the emitted energy).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani to include a FRET force probe, such that it is a type of optical sensing technique that can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces. Having a FRET biosensor in an orthodontic mouthpiece, such as the aligner of Shanjani, would include two fluorophores, each having an emission spectrum, one being emitted and one being absorbed as the forces are applied on the teeth, and the distance between the two analyzed.
Regarding claim 181, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 179 (see rejection above). Liu et al. wherein the photon absorber is the second fluorophore (Mechanical force-based FRET biosensors pp. 5 and FRET, pp. 2; the acceptor/receptor fluophore is a photon absorber as it absorbs photons from the emitted energy) having an absorption spectrum that overlaps with an emission spectrum of the detectable fluorophore (the emission spectrum of the two may overlap if the same force is applied).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani to include a FRET force probe, such that it is a type of optical sensing technique that can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces. Having a FRET biosensor in an orthodontic mouthpiece, such as the aligner of Shanjani, would include two fluorophores, each having an emission spectrum, one being emitted and one being absorbed as the forces are applied on the teeth, and the distance between the two analyzed.
Regarding claim 183, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 173 (see rejection above). Liu et al. teaches wherein the photon absorber is coupled to the detectable fluorophore (Mechanical Force-based FRET biosensors, pp. 5; the two are connected by a flexible linker).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani to include a FRET force probe, such that it is a type of optical sensing technique that can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces. Having a FRET biosensor in an orthodontic mouthpiece, such as the aligner of Shanjani, would include two fluorophores, each having an emission spectrum, one being emitted and one being absorbed as the forces are applied on the teeth, and the distance between the two analyzed.
Regarding claim 184, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 183 (see rejection above). Liu et al. teaches wherein the photon absorber and the detectable fluorophore are each coupled to the flexible tether (Mechanical Force-based FRET biosensors, pp. 5; the two are connected by a flexible linker).
Regarding claim 189, Shanjani et al. in view of Liu et al. teaches the orthodontic appliance of claim 171 (see rejection above). Shanjani teaches wherein the polymeric material comprises a plurality of additively formed layers ([0080-0081]).
Regarding claim 192, Shanjani in view of Kopelman, Lui and Swager teaches the orthodontic appliance of claim 171 (see rejection above). Shanjani teaches the force probe may be printed/formed with the appliance ([0101]). Applicant does not specify any criticality to the claimed value being exclusively 0.01-5 wt% or having any unexpected advantage or result over other values and mentions other possibilities within a greater range (see Specification para. ([0067]). It would have been obvious to one having ordinary skill in the art before the effective date of the invention that the sensor is some weight percent, greater than zero, of the appliance, since it is formed as part of it. It would have also been obvious to modify the sensor and select it having have some weight that is a small percentage of the appliance as it would perform as required without being too heavy or bulky and affecting the overall performance of the appliance or causing unwanted deformation.
Regarding claim 193, Shanjani in view of Kopelman, Lui and Swager teaches the orthodontic appliance of claim 171 (see rejection above). Kopelman teaches wherein the force probe comprises a Forster-based molecule ([0014]) or a mechanophore.
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani to include a FRET force probe, such that it is a type of optical sensing technique that can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces. Having a FRET biosensor in an orthodontic mouthpiece, such as the aligner of Shanjani, would include two fluorophores, each having an emission spectrum, one being emitted and one being absorbed as the forces are applied on the teeth, and the distance between the two analyzed.
Claim(s) 178 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani et al. (US 2019/0231477 A1), in view of Kopelman et al. (US2019/0099129A1), Liu et al. (NPL, (2020); Application of FRET Biosensors in Mechanobiology and Mechanopharmacological Screening; Frontiers in Bioengineering and Biotechnology; Vol. 8. DOI=10.3389/fbioe.2020.595497), and Swager et al. (US8,1858,437 B2), and further in view of Milczewski et al. (NPL, (2007). Orthodontic forces sensing with polymer PCF doi: http://dx.doi.org/10.1117/12.738594).
Regarding claim 178, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 176 (see rejection above), but is silent to wherein the mechanical force comprises a force greater than 1 pN applied to the localized region.
Milczewski et al. teaches a device in the same field of endeavor of sensing orthodontic forces (abstract). Milczewski teaches a force sensor is placed between an orthodontic appliance and a tooth and loads ranging from 0.09 to 4.7 N are measured and that forces required for dental movement typically range from 0 to 0.6 N (abstract).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to have the force on the tooth range from 0.09 to 407 N, as taught by Milczewski et al., since such forces are compatible with forces required for orthodontic dental movement.
Claim(s) 180 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani et al. (US 2019/0231477 A1), in view of Kopelman et al. (US2019/0099129A1), Liu et al. (NPL, (2020); Application of FRET Biosensors in Mechanobiology and Mechanopharmacological Screening; Frontiers in Bioengineering and Biotechnology; Vol. 8. DOI=10.3389/fbioe.2020.595497), and Swager et al. (US8,1858,437 B2), and further in view of Ajoula et al. (US 2007/0202498 A1) and Happe et al. (US 2006/0292592 A1).
Regarding claim 180, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 179 (see rejection above), but is silent to wherein the photon absorber is a quencher, wherein the quencher comprises 4-(dimethylaminoazo) benzene-4-carboxylic acid, a DDQ quencher, a BHQ quencher, a QSY quencher, a derivative thereof, or a combination thereof.
Ajoula et al. teaches a light emitting probe in the analogous art of fluorescent probes. Ajoula teaches fluorescent quenching is used to measure the distance between a fluorophore and a quencher when attached to a peptide linker ([0006]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the photon absorber to be a quencher, such that it would reduce the amount of light emitted when an interaction exists to avoid overheating of the force probe to preserve the mechanical properties of the device due to light and heat emission.
Happe et al. teaches a probe in the analogous art of fluorescent detection probes (Abstract). Happe teaches different probe compositions wherein a fluorophore and a quencher are used and they are selected to be an interactive fluorophore-quencher or FRET pair ([0019]. The quencher may be a BHQ quencher ([0019]) and the fluorophore may comprise a xanthene or naphthalene derivative ([0102]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to select the quencher to be comprise a BHQ derivative, as taught by Happe et al. as it is may be a suitable type of quencher for the selected fluorophore, such that the two can properly interact.
Claim(s) 182 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani et al. (US 2019/0231477 A1), in view of Kopelman et al. (US2019/0099129A1), Liu et al. (NPL, (2020); Application of FRET Biosensors in Mechanobiology and Mechanopharmacological Screening; Frontiers in Bioengineering and Biotechnology; Vol. 8. DOI=10.3389/fbioe.2020.595497), and Swager et al. (US8,1858,437 B2), and further in view of Happe et al. (US 2006/0292592 A1).
Regarding claim 182, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 181 (see rejection above), but is silent to wherein the second fluorophore comprises a xanthene derivative, a cyanine derivative, a squaraine derivative, a naphthalene derivative, a coumarin derivative, an oxadiazole derivative, an anthracene derivative, a pyrene derivative, an oxazine derivative, an acridine derivative, an arylmethine derivative, a tetrapyrrole derivative, or a combination thereof.
Happe et al. teaches a probe in the analogous art of fluorescent detection probes (Abstract). Happe teaches different probe compositions wherein a fluorophore and a quencher are used and they are selected to be an interactive fluorophore-quencher or FRET pair ([0019]. The quencher may be a BHQ quencher ([0019]) and the fluorophore may comprise a xanthene or naphthalene derivative ([0102]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to select the fluorophore to comprise a xanthene or naphthalene derivative, as taught by Happe et al. as it is may be a suitable fluorophore composition for the selected quencher.
Claim(s) 185 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani et al. (US 2019/0231477 A1), in view of Kopelman et al. (US2019/0099129A1), Liu et al. (NPL, (2020); Application of FRET Biosensors in Mechanobiology and Mechanopharmacological Screening; Frontiers in Bioengineering and Biotechnology; Vol. 8. DOI=10.3389/fbioe.2020.595497), and Swager et al. (US8,158,437 B2), and further in view of Ajoula et al. (US 2007/0202498 A1).
Regarding claim 185, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 184 (see rejection above), but is silent to wherein the flexible tether comprises a polymer chain or a peptide chain.
Ajoula et al. teaches a light emitting probe in the analogous art of fluorescent probes. Ajoula teaches fluorescent quenching is used to measure the distance between a fluorophore and a quencher when attached to a peptide linker ([0006]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to select a peptide linker as the tether that connects the two fluorophores, as it is a suitable type of linker for a FRET biosensor.
Claim(s) 186 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani et al. (US 2019/0231477 A1), in view of Kopelman et al. (US2019/0099129A1), Liu et al. (NPL, (2020); Application of FRET Biosensors in Mechanobiology and Mechanopharmacological Screening; Frontiers in Bioengineering and Biotechnology; Vol. 8. DOI=10.3389/fbioe.2020.595497), and Swager et al. (US8,1858,437 B2), and further in view of Patel et al. (US 2013/0340188 A1).
Regarding claim 186, Shanjani in view of Kopelman, Liu and Swager teaches the orthodontic appliance of claim 173 (see rejection above), but is silent to wherein the detectable fluorophore is selected from the group consisting of a spiropyran, an aromatic disulfide, a nitroxyl, a stilbene and a dye.
Patel et al. teaches a device in the same field of endeavor of dental devices with force sensing capabilities (abstract). Patel et al. teaches the force sensor may be a mechanophore within the polymeric material of the device and may comprise a spiropyran molecule (Col. 2 ll. 39-44).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to select a single-molecule force probe, such as a mechanophore, as a force probe for the orthodontic device of Shanjani, such that it would be a suitable type of probe to detect force in a dental application.
Claim(s) 190 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani et al. (US 2019/0231477 A1), in view of Kopelman et al. (US2019/0099129A1), Liu et al. (NPL, (2020); Application of FRET Biosensors in Mechanobiology and Mechanopharmacological Screening; Frontiers in Bioengineering and Biotechnology; Vol. 8. DOI=10.3389/fbioe.2020.595497), and Swager et al. (US8,1858,437 B2), and further in view of Li et al. (US2017/0007367A1).
Regarding claim 190, Shanjani et al. in view of Liu et al. teaches the orthodontic appliance of claim 171 (see rejection above), but is silent to wherein the polymeric material comprises a thermoset material.
Li et al. teaches a device in the same field of orthodontic appliances (abstract). Li teaches the orthodontic appliance is made from a polymer material and may be a thermoset material such that it may be selected for direct fabrication (([0070], [0096]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to select the material of the appliance to be a thermoset polymer, as taught by Li et al., such that it would be suitable for an orthodontic appliance that is directly fabricated.
Claim(s) 191 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani et al. (US 2019/0231477 A1), in view of Kopelman et al. (US2019/0099129A1), Liu et al. (NPL, (2020); Application of FRET Biosensors in Mechanobiology and Mechanopharmacological Screening; Frontiers in Bioengineering and Biotechnology; Vol. 8. DOI=10.3389/fbioe.2020.595497), and further in view of Hamner et al. (US 2004/0091695 A1).
Regarding claim 191, Shanjani et al. teaches an orthodontic appliance (abstract) comprising:
A shell comprising a polymeric material ([0038]), wherein the shell comprises a plurality of tooth receiving cavities (see Figures); and
a force probe ([0077], [0105-0106] and [0101]); the appliance may have sensors that can measure force, stress/strain or other parameters of force to determine the state of the appliance and the sensors may be embedded, formed within or printed with the material of the appliance).
Shanjani et al. teaches the sensor may be an optical sensor, such as sensor 1008, that may be used to detect movement and/or position of one or more regions of the apparatus relative to other regions ([0106]) and it may include an emitter and a detector ([0124]).
Kopelman et al. teaches a device in the same field of endeavor of orthodontic appliances (abstract). Kopelman teaches the device may be an orthodontic appliance ([0083]) and may be made from a polymeric material ([0121]). The appliance has a biosensor (107) that may be formed with or connected integrally with the appliance ([0056]) and may be an optical sensor such as a florescence sensor such as FRET ([0014]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani to include a FRET force probe, such that it is a type of optical sensing technique that can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces.
Shanjani et al. is silent to wherein means for probing an emission spectrum of the polymeric material, wherein: the means for probing comprises a first emission spectrum when in an unstrained configuration; and the means for probing comprises a second emission spectrum when in a strained configuration, wherein the first emission spectrum and the second emission spectrum are distinct from one another, wherein a transition between the unstrained configuration and the strained configuration occurs when a force is applied to the orthodontic appliance.
Liu et al. teaches force probes such as FRET probes are commonly used for mechanical testing of strain in mechanobiology (Mechanical force-based FRET biosensors pp. 5). FRET biosensors function by having a donor and an acceptor connected by a flexible linker and the distance between the donor and acceptor is analyzed to directly quantify and detect the force-induced effects (Mechanical force-based FRET biosensors pp. 5). In other words, two fluorophores are coupled, one a donor that emits energy the other an acceptor that absorbs the energy emitted by the first fluorophore, and the spectral overlap between the emission spectrum of the donor and the excitation spectrum of the acceptor is observed, such that the distance between the two fluorophores is calculated and analyzed to reflect dynamic behavior due to the applied forces (FRET, pp. 2).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the invention to modify the device of Shanjani and Kopelman to have the FRET force probe similar to Luiu’s, such that it can efficiently measure changes between two sites and reflect dynamic behavior according to applied forces. Having a FRET biosensor in an orthodontic mouthpiece, such as the aligner of Shanjani, would include two fluorophores, each having an emission spectrum, one being emitted and one being absorbed as the forces are applied on the teeth, and the distance between the two analyzed.
Shanjani further teaches the sensor may be embedded, encapsulated, printed, or formed with the appliance ([0101]) and the material for fabricating the appliance may be a metal, glass, carbon fiber composite, a reinforced composite, aluminum, biological materials or combinations of them and can be direct fabricated such as by 3D printing or additive manufacturing ([0081]) but does not explicitly teach wherein the orthodontic appliance is formed from a curable resin comprising the means for probing.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the orthodontic appliance be formed from a curable resin, such that it is a proper material well known in the art for additive manufacturing orthodontic appliances and may be selected out of the list of possible materials as to achieve desired properties.
Shanjani et al. does not teach the force probe incorporated into the backbone of the polymeric material. Hamner et al. teaches a polymeric material that is pressure sensitive (abstract). Hamner teaches the polymeric material may be a part of a system that undergoes fluorescence resonance energe transfer (FRET) ([0008], [0021]) and may include probes in its chain to measure deformation when subject to pressure ([0008]). Hamner teaches the photoreactive FRET system is copolymerized with the polymer during polymer synthesis such that the elastomeric properties can be reflected by the FRET when the pressure is increased or lowered ([0025]). Fluorescent distance probing molecules are copolymerized onto polymer chains during polymer synthesis and measure the nano-deformation of the polymeric material as it is placed under load and as the material compresses or expands, the polymer chains recognize themselves in response to the load and the probes report the movement as detected by the emission spectrum of the polymer ([0017]). Having the fluorescent monomers directly attached to the elastomer chains have the advantage of 1) no dyes are lost during sensor use due to vaporization, Sublimation, or migration to the environment, 2) aggregation of the dyes are prevented, and 3) the material properties together with the donor-acceptor ratio determine the sensitivity to pressure, and response of the luminescent pressure sensor ([0026]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the force probe be intermixed with the polymeric material, as taught by Hamner et al., such that it would provide an integral system that directly reflects the polymer’s sensitivity to pressure as well as avoiding the risks from the sensor interacting with the environment and therefore protection of the sensor is ensured.
Response to Arguments
Applicant's arguments filed 10/3/2025 have been fully considered but they are not persuasive.
Applicant argues that the references do not teach the claim as amended, now including the limitation of the force probe being for detecting a force applied to the orthodontic appliance. Applicant states that Shanjani discloses only a device-level sensor and not a molecular force probe as a shell of an orthodontic appliance having tooth receiving cavities for detecting force applied to the appliance. Applicant further states that Kopelman does not remedy the deficiencies of Shanjani as it teaches a FRET sensor for detecting analytes in tissue, blood, lymph or saliva, and not to detect a force applied to an orthodontic appliance. Applicant also argues that Liu, Swager, and Hamner provide no guidance or suggestion that would motivate one or ordinary skill in the art to use a polymeric material containing a FRET biosensor as a shell of an orthodontic appliance to detect a forced applied to the appliance.
However, these arguments are not persuasive because although Shanjani does not teach the force probe as a molecular force probe dispersed within the polymer, it teaches a force sensor used to determine a state of the orthodontic appliance, such that it can determine stress or strain, deformation, defects, position of one or more regions of the appliance relative to other regions of the appliance, in addition to other possibilities ([0077], [0106-0108]) and therefore teaches the concept of using a force sensor to determine forces or effects of forces on the polymeric orthodontic appliance itself. Kopelman teaches the concept of using a FRET biosensor integrated in an orthodontic appliance. Liu discloses the use of a FRET probe for mechanical testing of forces in mechanobiology and describes the mechanism of a FRET probe in such application. Furthermore, Swager discloses a FRET probe being bonded to a polymeric material using electrostatic interaction. Hamner discloses a FRET probe dispersed within the matrix of a polymeric material that is an elastomer. Kopelman is merely being relied on to show that a FRET sensor may be used with a polymeric appliance. Liu is merely being relied on to show that a FRET sensor is used to determine mechanical forces in biological applications. Swager and Hamner are merely being used to show that a FRET sensor may be dispersed within the matrix of an elastomeric polymer (fully capable of being used in an orthodontic appliance) and be bonded to the polymer by electrostatic interactions. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, the combination teaches the amended claims.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, although Lui does not specifically mention a dental or orthodontic application, it describes a biosensor that uses the same FRET technology as claimed and relates to solving the same problem as Shanjani (i.e. using a sensor for measuring biomechanics) and is used within the body. Therefore, it is considered analogous art. Hamner also describes a polymeric material that is pressure sensitive and using a FRET system to analyze its pressure dynamics. All FRET systems work in the same manner and since the system of Hamner is used to analyze the pressure/force behavior of a polymeric material, it pertains to the same problem and is therefore considered analogous art to Shanjani. Swager is considered to evidence that electrostatic interactions may be present between a polymer and a FRET sensor and therefore is prevalent to the modified appliance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/LINA FARAJ/ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
12/11/2025