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 .
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. EP21184167.1, filed on 07/07/2021.
For the purpose of examination, the priority date for claims 1-14 is 07/07/2021.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
- "45" as shown in Fig. 4A
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
-Page 6, line 15, "second chop" should be "second chip".
-Page 9, line 6, "One RFID tags" should be "One RFID tag".
Appropriate correction is required.
The amendment filed 01/05/2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application PCT/EP2022/068502 and of the foreign application EP21184167.1 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 07/05/2022, see MPEP 1893.03(b). Therefore the specification amendment of 01/05/2024 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claims 1, 5, and 7 are objected to because of the following informalities:
Claim 1, lines 1-2 state, "... wherein the support structure has a shape which fits to the teeth of the user and has a deformable region...". Examiner recommends amending the claim language to, "…wherein the support structure has a shape which is configured to fit
Claim 5, lines 1-2 state, “…wherein the support structure comprises a guard that fits over the teeth of one jaw…”. Examiner recommends amending the claim language to, “…wherein the support structure comprises a guard that is configured to fit
Claim 7, line 2 states, “..on RFID tag…”. Examiner recommends amending the claim language to, “…one RFID tag…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim recites a computer program and the specification supports this computer program code as being transitory (refer to page 11, lines 14-17). Products that do not have a physical or tangible form are not directed to any of the statutory categories.
Step 1 – Determination as to whether the claims are directed to a statutory category as specified in 35 U.S.C. 101 (MPEP 2106.03)
The claim(s) recite(s) a method of detecting is an orthodontic aligner is currently being worn, which falls under the category of a process.
Step 2A Prong 1 – Determination as to whether the claims recite a Judicial Exception including an abstract idea, law of nature, or natural phenomenon (MPEP 2106.04)
Regarding claim 11, the steps of analyzing the reflected response signal and determining if the aligner is being worn are abstract ideas, steps capable of being performed in the human mind. Analyzing a reflected response to determine how the RFID tag has been modified is a mental evaluation that can be performed without a computer.
Regarding claims 12-13, the steps of determining a level of fit and tooth position based on the received reflected response are mental evaluations for determining how the modification of the RFID tag describes the aligner’s deformation.
Step 2A, Prong Two – Determination as to whether the claims as a whole integrate the judicial exception into a practical application
This judicial exception is not integrated into a practical application because:
Regarding claims 11-13, the claimed invention does not recite additional elements that integrate the judicial exception into practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea(s) to a particular technological environment or field of use (MPEP 2106.04(d)). The use of a controller to perform these steps is insignificant extra solution activity and does not amount to an inventive concept, particularly when the activity is well-understood and conventional. The steps of generating and receiving a signal are conventional steps to any process that relies on RFID tags for data transmission. For at least these reasons and as claims 11-13 do not recite additional elements which integrate the judicial exception into a practical application, the abstract mental processes and mathematical concepts identified for claims 11-13 are not integrated into a practical application.
Step 2B – Determination as to whether the claims amount to significantly more than the judicial exception (MPEP 2106.05)
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
Regarding claims 11-13, as set forth above with respect to Step 2A Prong One, the claimed method steps are all capable of being performed mentally and represent nothing more than concepts related to performing observations, evaluations, and judgements, which fall within the judicial exception. The claimed steps of analyzing the reflected response signal, determining if the aligner is being worn, determining a level of fit and tooth position require nothing more than a generic computer processor. The disclosure does not describe additional features to suggest these devices are beyond a generic component for the apparatus. Additionally, the design method is not disclosed as improving the manner in which the apparatus operates. Mere recitation of generic conventional processing used in a conventional manner to perform conventional computer functions that are well understood and routine does not amount to “significantly more” than the judicial exception. The claims do not go beyond inputting data (“ receiving”) and processing data ( “detecting”, “determining”, “analyzing”) with a standard computer.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. The claims set forth do not require that the method be implemented by a particular machine and they do not require that the method particularly transforms a particular article. When viewed as a combination, the identified additional elements set forth a process of analyzing information of specific content and are not directed to any particularly asserted inventive technology for performing these functions. The disclosure and claims do not require anything beyond a generic computer to obtain and analyze the data according to mathematical algorithms. Therefore, the claimed method falls within the judicial exception to patent eligible subject matter of an abstract idea without significantly more.
Claim Rejections - 35 USC § 102
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) 1-3, and 5-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alauddin et al. (US 20170056131 A1).
Regarding claim 1, Alauddin et al. discloses an orthodontic aligner (10), comprising:
a support structure (10) for placing in the mouth of a user, wherein the support structure (10) has a shape which fits to the teeth of the user and has a deformable region (refer to Paragraph [0039]; the aligner (10) is configured to fit onto a set of teeth (12) and press firmly against the set of teeth; the entire aligner (10) is therefore deformable); and
at least one passive RFID tag (18) (refer to Paragraph [0053]; a NFC chip can be connected to the bottom electrode (26), top electrode (38) or both, to enable NFC, wherein NFC is a subset, or species, of RFID; per MPEP 2131.02(I), a species (NFC) anticipates the genus (RFID); further, no battery is attached, making the sensor (18) a passive device) mounted to the support structure, comprising first (20+26) and second portions (38+44) coupled to the deformable region (refer Paragraph [0039], Fig. 3 below; each sensor (18) is disposed in the aligner (10), with the entire aligner (10) being deformable), wherein the first (20+26) and second portions (38+44) each comprise a respective antenna portion (26, 38), which together define the antenna for the RFID tag (18) (refer to Paragraphs [0040], [0042], Fig. 5 below; an RFID antenna is defined as a looped strip of conductive material; the top (38) and bottom (26) electrode are comprised of loops of conductive material, thereby each being individual antennas, which together form the antenna portion of the RFID tag (18)), wherein a relative position between the first (20+26) and second portions (38+44) is adjustable by deformation of the deformable region (10) between at least a first relative position when the orthodontic aligner (10) is worn by the user and a second relative position when the orthodontic aligner (10) is not being worn (refer to Paragraphs [0039], [0047], [0048], Figs. 6A-6B; as pressure is applied to the RFID tag (18) by the aligner (10) pressing to the teeth (12), the first (20+26) and second portions (38+44) move towards each other, compressing the deformable RFID tag material (32) between them as shown in Fig. 6B; when the aligner (10) is not worn, the first (20+26) and second portions (38+44) are not pressed towards each other as shown in Fig. 6A), wherein a response of the RFID tag to an external interrogation signal is dependent on the relative position between the first and second portions (refer to Paragraphs [0047], [0048], Figs. 6A-6B; when the aligner (10) is not worn, and the RFID tag first (22+26) and second (38+44) portions are not deformed, a higher frequency is emitted; when the aligner is worn (10) and the first (22+26) and second (38+44) portions are deformed, a lower frequency is emitted).
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Regarding claim 2, Alauddin et al. discloses the aligner of claim 1, comprising a plurality of RFID tags (18), each comprising first (20+26) and second portions (38+44) coupled to the deformable region (refer Paragraph [0039], Fig. 3 above; a plurality of sensors (18) are aligned to correspond to a plurality of teeth (12) and disposed in the aligner (10), with the entire aligner (10) being deformable).
Regarding claim 3, Alauddin et al. discloses the aligner of claim 2, comprising a plurality of RFID tags (18) associated with one or more individual teeth (12A, 12B) to be monitored (refer Paragraph [0039], Fig. 3 above; each sensor (18) is aligned to correspond to a tooth (12) and disposed in the aligner (10), with the entire aligner (10) being deformable).
Regarding claim 5, Alauddin et al. discloses the aligner of claim 1, wherein the support structure (10) comprises a guard that fits over the teeth of one jaw (refer Paragraph [0039], Fig. 3 above; each sensor (18) is aligned to correspond to a tooth (12) of the upper jaw) .
Regarding claim 6, Alauddin et al. discloses the aligner of claim 5, wherein the deformable region (10) includes a surface which makes contact with occlusal tooth surfaces (refer to Fig. 6 below), and at least on RFID tag (18) comprises upper (38+44) and lower portions (20+26) which move together when the aligner (10) is worn (refer to Paragraphs [0048], [0049], Figs. 6A-6B; as pressure is applied to the RFID tag (18) by the aligner (10) pressing to the teeth (12), the upper (20+26) and lower portions (38+44) move towards each other, compressing the deformable RFID tag material (32) between them as shown in Fig. 6B).
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Regarding claim 7, Alauddin et al. discloses the aligner of claim 5, wherein the deformable region (10) includes a surface which faces the labial tooth surfaces (refer to Fig. 6 below), and at least on RFID tag (18) comprises inner (32) and outer portions (20+26, 38+44) which move together when the aligner (10) is worn (refer to Paragraphs [0048], [0049], Figs. 6A-6B; as pressure is applied to the RFID tag (18) by the aligner (10) pressing to the teeth (12), the outer (20+26, 38+44) regions move together, compressing the deformable inner RFID tag material (32) between them as shown in Fig. 6B).
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Regarding claim 8, Alauddin et al. discloses an aligner system (57; refer to Paragraph [0014], Fig. 8; a system (57) for quantifying the amount of pressure exerted on a tooth of a patient by the aligner (10) is disclosed), comprising:
the aligner (10) of claim 1;
an RFID interrogator unit (72) for interrogating the one or more RFID tags and receiving a reflected response (refer to Paragraph [0072]; a smartphone or personal computing device (72) uses a software application to generate input signals (52) and collect output signals (54)); and
a controller for determining whether the aligner is worn from the reflected response (refer to Paragraphs [0014], [0048], [0055], Figs. 6A-6B; the processor (78) includes micro-controllers configured to receive the amount of pressure from the detection instrument; as shown is Figs. 6A-6B, when the aligner (10) is not worn, a higher frequency reading is collected, correlating to lower pressure; when the aligner (10) is worn, a pressure is exerted on the sensor (18), such that a higher pressure reading is collected; therefore, the controller of the processor (78) is functionally capable of determining whether the aligner (10) is being worn from the frequency outputs (54)).
Regarding claim 9, Alauddin et al. discloses the system of claim 8, wherein the controller (micro-controller of processor (78)) is adapted to determine a level of fit of the aligner (10) to the user from the received reflected response (54) (refer to Paragraphs [0007], [0061]-]0063]; aligner (10) pressure readings below a set threshold indicate the patient is ready to be fit for a new aligner, meaning the current aligner, equivalent to the aligner fitting loosely; pressure readings above a set threshold indicate the patient’s teeth need immediate evaluation to avoid root resorption, equivalent to the aligner (10) fitting too tightly).
Regarding claim 10, Alauddin et al. discloses the system of claim 8, wherein the controller (micro-controller of processor (78)) is adapted to determine tooth position information from the received reflected response (54) (refer to Paragraph [0061]; the interface (63) indicates the position of the tooth in the patient’s mouth).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alauddin et al. (US 20170056131 A1) in view of Ao et al. (CN 108577993 B); refer to the provided translation for Ao et al.
Regarding claim 4, Alauddin et al. discloses the aligner (10) of claim 1, wherein the relative position between the first (20+26) and second portions (38+44) is adjustable between a first state and a second state (refer to Paragraphs [0039], [0047], [0048], Figs. 6A-6B; when the aligner (10) is not worn, the first (20+26) and second portions (38+44) are not pressed towards each other as shown in Fig. 6A, a first state; as pressure is applied to the RFID tag (18) by the aligner (10) pressing to the teeth (12), the first (20+26) and second portions (38+44) move towards each other, compressing the deformable RFID tag material (32) between them as shown in Fig. 6B, a second state); however, Alauddin et al. does not disclose these relative positions affecting the functionality of the RFID tag to respond to interrogation signals.
Ao et al. discloses an orthodontic aligner (10) comprising an RFID tag (20) in the same field of endeavor (refer to Paragraphs 10, 25, Fig. 1). The RFID tag (20) comprises a switch device (25) along with first (252) and second portions (256), wherein the relative position between the first (252) and second portions (256) is adjustable between a first state in which the RFID tag (20) is non-functional and will not respond to an interrogation signal (refer to Paragraphs 29-30, Figs. 3A-3B; when the elastic member (256) is in a natural state, the second rigid member (252) is separated from the elastic member (256), which is equivalent to the switch (25) being disconnected) and a second state in which RFID tag (20) is functional and will respond to an interrogation signal (refer to Paragraphs 29-30, Figs. 4A-4B; when the elastic member (256) is in a compressed state, the second rigid member (252) is connected to the elastic member (256), which is equivalent to the switch (25) being connected and capable of responding to an interrogation signal). The switch (25) allows the user to determine the wearing time of the aligner (10) by only responding to signals after the aligner is put on (refer to Paragraph 10).
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 RFID tag as taught by Alauddin et al. with a switch device (25) as taught by Ao et al. in order to allow the user to determine the wearing time of the aligner (refer to Paragraph 10).
Claim(s) 4, and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alauddin et al. (US 20170056131 A1).
Regarding claim 11, Alauddin et al. discloses a method of detecting pressure of an orthodontic aligner (refer to Paragraphs [0012]-[0013]; a method of sensing pressure of an aligner and quantifying the pressure is disclosed), comprising:
generating a control signal for controlling an RFID interrogator unit (72) to generate an RFID interrogation signal (52) for delivery to one or more passive RFID tags (18) (refer to Paragraph [0053]; a NFC chip can be connected to the bottom electrode (26), top electrode (38) or both, to enable NFC, wherein NFC is a subset, or species, of RFID; per MPEP 2131.02(I), a species (NFC) anticipates the genus (RFID); further, no battery is attached, making the sensor (18) a passive device) forming part of the aligner (10) (refer to Paragraph [0072]; a smartphone or personal computing device (72) uses a software application to generate input signals (52) to the sensors (18)); and
receiving a signal based on the reflected response from the passive RFID tag or tags (18) (refer to Paragraph [0072]; a smartphone or personal computing device (72) uses a software application to collect output signals (54) from the sensors (18)) and analyzing the reflected response signal (54) (refer to Paragraphs [0014], [0060]; based on the output signals (54) the system (57) quantifies the amount of pressure on a tooth of a patient by the aligner (10)), thereby to detect antenna characteristics of the RFID tag (18) which depend on a relative position between first (20+26) and second portions (38+44) of the RFID tag (18) (refer to Paragraph [0048], [0071], Figs. 6A-6B; the signal output (54) is a function of the distance between the antenna regions (26, 38); as pressure is applied to the RFID tag (18) by the aligner (10) pressing to the teeth (12), the first (20+26) and second portions (38+44) move towards each other, compressing the deformable RFID tag material (32) between them as shown in Fig. 6B; when the aligner (10) is not worn, the first (20+26) and second portions (38+44) are not pressed towards each other as shown in Fig. 6A).
Alauddin et al. does not explicitly disclose this method being used to detect if an orthodontic aligner (10) is being worn; however, Alauddin et al. discloses that the output signal (54) of the aligner (10) varies according to the pressure being applied, wherein a higher pressure is associated with the device being worn and applying force to the teeth and a lower pressure is associated with the device not being worn, as no force is not being applied to the teeth (refer to Paragraphs [0048], [0071], Figs. 6A-6B). Further, Alauddin et al. discloses that the interface may provide any other relevant data beneficial to the orthodontist based on the received pressure data (refer to Paragraph [0061]), and further indicates wear time, or whether the aligner is being worn, as relevant to the orthodontist (Paragraph [0009]).
Therefore, 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 Alauddin et al. to include determining if the orthodontic aligner is being worn based on the pressure sensor (18) data.
Regarding claim 12, Alauddin et al. discloses the method of claim 11, further comprising determining a level of fit of the aligner (10) to the user from the received reflected response (54) (refer to Paragraphs [0061]-[0063], [0071]; aligner (10) pressure readings below a set threshold indicate the patient is ready to be fit for a new aligner, meaning the current aligner, equivalent to the aligner fitting loosely; pressure readings above a set threshold indicate the patient’s teeth need immediate evaluation to avoid root resorption, equivalent to the aligner (10) fitting too tightly).
Regarding claim 13, Alauddin et al. discloses the method of claim 11, comprising determining tooth position information from the received reflected response (54) (refer to Paragraphs [0061], [0071]; the interface (63) indicates the position of the tooth in the patient’s mouth).
Regarding claim 14, Alauddin et al. discloses a computer program comprising computer program code which is adapted, when said program is run on a computer, to implement the method of claim 11 (refer to Paragraphs [0056]-[0057], [0075]-[0076]; computer code for executing the disclosed method is embodied as a software application (92) executed by the processor (78)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adriena J Webb Lyttle whose telephone number is (571)270-7639. The examiner can normally be reached Mon - Fri 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADRIENA J WEBB LYTTLE/Examiner, Art Unit 3772
/THOMAS C BARRETT/SPE, Art Unit 3799