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 .
Specification
The use of the term “BLUETOOTH”, which is a trade name or a mark used in commerce, has been noted in this application in paragraphs [0008] and [0019]. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities: For consistency in readability of the “plans” in Claim 1, it is suggested to revise “a modified plan of orthodontic treatment” to be “a modified prescribed plan of orthodontic treatment.” Appropriate correction is required.
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 do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“read-write device” in claim 1 for “writing information”
The claim limitation is interpreted according to paragraph [0007] of Applicant’s Specification with “The memory can be divided into two parts— one read-only part for storing encrypted read-only information and one read-write part,” and “The read-write part of the chip is for storing the data, including sensor signals, additional information, and further information.”.
“Data collection unit” in claim 2 for “collecting data”
The claim limitation is interpreted according to paragraph [0061] with “ data collection unit further comprises a wireless receiver for wirelessly receiving data from the pressure-sensitive sensors” and [0060] “a data collection unit for collecting data from the pressure-sensitive sensors.”
“Data analysis unit” in claim 2 for “analyzing the collected data”
The claim limitation is interpreted according to paragraph [0060] “data analysis unit for analyzing the collected data to determine the effectiveness of the orthodontic treatment”; [0047] “Orthodontist analyzes the data and makes timely adjustments.” Based on the specification, it is possible that the “data analysis unit” is disclosed as an orthodontist. Alternatively, Figure 2 shows an output of a graph output “reporting” image on “remote device 103”. Looking to Paragraph [0061] “the data analysis unit is configured to generate reports indicating the progress of the orthodontic treatment” and [0010], “the remote device can be any computing device or system, such as a personal computer, laptop, tablet, mobile device, wearable device, etc.”
“Communication unit” in claim 2 for “transmitting the analyzed data”
The claim limitation is interpreted according to paragraph [0060] with “a communication unit for transmitting the analyzed data to a remote server” and [0008] “the data can be transmitted to a remote device through a wire or a wireless communication technology…the chip contains a wireless communication circuit and the data can be transmitted to a remote device through any existing wireless communication technologies including Wi-Fi, Bluetooth, WiMax, and cellular network. “
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the prescribed plan of orthodontic treatment" in line 25 - 26. There is insufficient antecedent basis for this limitation in the claim. There is no previously -recited “prescribed plan”. For the purposes of examination, the term "the prescribed plan of orthodontic treatment" is deemed to claim "a prescribed plan of orthodontic treatment". Claims 3 – 7 are similarly rejected due to their dependence on Claim 1.
The term “special conditions” in claim 1 is a relative term which renders the claim indefinite. The term “special” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Examples of “special conditions” are given in Applicant’s Specification at [0026], but it remains unclear what constitute “irregularities” during brace application, and to what level they must be irregular in order to be “special”. For the purposes of examination, the term “special conditions” is deemed to claim “initial installation condition notes.” Claims 3 – 7 are similarly rejected due to their dependence on Claim 1.
Claim 1 recites the limitation “an invisible dental brace” in line 3. It is unclear if it is intended to be the same or different than the invisible dental brace previously-recited in the preamble of the claim. For the purposes of examination, the term "an invisible dental brace” is deemed to claim “the invisible dental brace.” Claims 3 – 7 are similarly rejected due to their dependence on Claim 1.
Claim 1 recites the limitation “at least one pressure-sensitive sensor” in line 4. It is unclear if it is intended to be the same or different than the pressure-sensitive sensor(s) previously-recited in the preamble of the claim. For the purposes of examination, the term “at least one pressure-sensitive sensor” is deemed to claim “the at least one pressure-sensitive sensor.” Claims 3 – 7 are similarly rejected due to their dependence on Claim 1.
Claim 1 recites the limitation "the usage" in line 22. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited usage in the claim. For the purposes of examination, the term "the usage" is deemed to claim "a usage." Claims 3 – 7 are similarly rejected due to their dependence on Claim 1.
Claim 1 recites the limitation "the patient" in line 23 of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear if it is intended to be the same or different than the orthodontic patient previously-recited in the claim. For the purposes of examination, the term "the patient" is deemed to claim "the orthodontic patient." Claims 3 – 7 are similarly rejected due to their dependence on Claim 1.
The term “by a specifically designed software” in claim 1 is a relative term which renders the claim indefinite. The term “specifically” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what about the software is “specifically” designed, and what the metes and bounds of determining specificity of design are. For the purposes of examination, the term “by a specifically designed software” is deemed to claim “by a software.” Claims 3 – 7 are similarly rejected due to their dependence on Claim 1.
Claim 2 recites the limitation "a remote server" in line 9 of the claim. It is unclear if this is intended to be the same or different than the previously-recited “remote server” in Claim 2. For the purposes of examination, the term "a remote server" is deemed to claim "the remote server”.
Claim 2 recites the term “a set of invisible dental braces” in line 3 of the claim. It is unclear if it is intended to be the same or different than the invisible dental brace previously recited in the preamble of the claim. For the purposes of examination, the term “a set of invisible dental braces” is deemed to claim “a set of the system of invisible dental braces”.
Claim 2 recites the term “each brace” in line 3 of the claim. It is unclear if it is intended to be part of the set of invisible braces or not. For the purposes of examination, the term “each brace” is deemed to claim “each brace of the set of invisible dental braces”.
Claim 2 recites the term “a pressure-sensitive sensor” in line 3 of the claim. It is unclear if it is intended to be part of the pressure sensitive sensors recited in the preamble or not. For the purposes of examination, the term “a pressure-sensitive sensor” is deemed to claim “a pressure-sensitive sensor of the pressure-sensitive sensors”.
Claim 2 recites the limitations "the pressure” (line 4 of the claim), “the teeth” (line 4 of the claim), “the effectiveness” (line 7 of the claim), “the orthodontic treatment”(line 7 of the claim), and “the user” (line 10 of the claim). There is insufficient antecedent basis for each of these limitations in the claim. There is no previously-recited pressure, teeth, effectiveness, orthodontic treatment, or user, respectively. For the purposes of examination, the terms "the pressure”, “the teeth”, “the effectiveness”, “the orthodontic treatment”, and “the user” are respectively deemed to claim "a pressure”, “a teeth”, “a effectiveness”, “an orthodontic treatment”, and “a user.”
Claims 3 (line 1), Claim 4 (line 1), and Claim 5 (line 2 – 3) each recite the limitation "the pressure-sensitive sensors”. It is unclear if these are intended to be the same or different than the “at least one pressure-sensitive sensor” recited in Claim 1, from which this claim depends. For the purposes of examination, the term “the pressure-sensitive sensors” is deemed to claim "the at least one pressure-sensitive sensor.”
Claim 5 recites the term “the data collection unit” in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited data collection unit in claim 5 or claim 1 from which this claim depends. For the purposes of examination, the term “the data collection unit” is deemed to claim “a data collection unit”.
Claim 6 recites the term “the data analysis unit” in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited data analysis unit in claim 6 or claim 1 from which this claim depends. For the purposes of examination, the term “the data analysis unit” is deemed to claim “a data analysis unit”.
Claim 6 recites the term “the progress of the orthodontic treatment” in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited progress in claim 6 or claim 1 from which this claim depends. For the purposes of examination, the term “the progress of the orthodontic treatment” is deemed to claim “a progress of the orthodontic treatment.”
Claim 8 recites the term “a set of invisible dental braces, each brace comprising”. It is unclear if the “brace” is intended to be one of the set of invisible dental braces, or a different unit associated with braces. For the purposes of examination, the term “a set of invisible dental braces, each brace comprising” is deemed to claim, “a set of invisible dental braces, each invisible dental brace comprising”. Claims 9 – 17 are similarly rejected due to their dependence on Claim 8.
Claim 9 recites the term “monitoring the forces” in line 2. There is insufficient antecedent basis for this limitation in the claim. The are no previously-recited forces in claim 9 or claim 8 from which this claim depends. For the purposes of examination, the term “monitoring the forces” is deemed to claim “monitoring forces”.
Claim 9 (line 2) and Claim 13 (line 2) each recite the limitation "exerted on the teeth” . There is insufficient antecedent basis in the claim. There are no previously-recited teeth. For the purposes of examination, the term "exerted on the teeth” is deemed to claim “exerted on teeth of a patient.”
Claim 11 (line 2) and Claim 14 (line 2) each recite the limitation "and tooth pressure data" in line 2. It is unclear if this is intended to be the same or different than the previously-recited tooth pressure data in Claim 8. For the purposes of examination, the term "and tooth pressure data" is deemed to claim "and the tooth pressure data"
Claim 12 recites the limitation "the progress of orthodontic treatment”. There is insufficient antecedent basis in the claim. There is no previously-recited progress of orthodontic treatment. For the purposes of examination, the term "the progress of orthodontic treatment” is deemed to claim "a progress of orthodontic treatment”.
Claims 13, 15, and 16 each recite the limitation "the orthodontist" in their respective line 3. There is insufficient antecedent basis for this limitation in the claim. There is no previously -recited “orthodontist”. For the purposes of examination, the term "the orthodontist" is deemed to claim "an orthodontist."
Claim 15 recites the limitation "the patient" in line 3. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited patient. For the purposes of examination, the term "the patient" is deemed to claim "a patient”.
Claim 16 recites the limitation "detecting the alignment of the teeth" in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited alignment or teeth. For the purposes of examination, the term "detecting the alignment of the teeth" is deemed to claim “detecting an alignment of teeth of a patient”.
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.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 2, the claim recites an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Claim 2 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Claim 2 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, Claim 2 recites an abstract idea.
Specifically, Claim 2 recites (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 2
A system of invisible dental braces equipped with pressure-sensitive sensors, comprising:
a set of invisible dental braces, each brace comprising a pressure-sensitive sensor for monitoring the pressure exerted on the teeth;
a data collection unit for collecting data from the pressure-sensitive sensors; a data analysis unit for analyzing the collected data to determine the effectiveness of the orthodontic treatment;
a communication unit for transmitting the analyzed data to a remote server;
a remote server for storing and managing the analyzed data;
a user interface for accessing and displaying the analyzed data to the user.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Claim 2 these limitations include:
Observation and judgement of the collected data to observe and judge the effectiveness of the orthodontic treatment;
Observation and judgement to manage the analyzed data;
all of which are grouped as mental processes or mathematical algorithms under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in Claim 2 is not integrated into a practical application under 2019 PEG because the additional elements identified in Claim 2, either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“set of invisible dental braces”
“pressure sensitive sensor”
“data collection unit”
“data analysis unit”
“communication unit”
“remote server”
“user interface”
Additional elements recited include “set of invisible dental braces”, “pressure sensitive sensor”, “data collection unit”, “data analysis unit”, “communication unit”, “remote server”, and “user interface. These components are recited at a high level of generality, i.e., as a set of invisible dental braces performing a generic function of exerting pressure on the teeth. These generic hardware component limitations for “set of invisible dental braces”, “pressure sensitive sensor”, “data collection unit”, “data analysis unit”, “communication unit”, “remote server”, and “user interface” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Claim 2 include pre-solution activity limitations, such as:
a set of invisible dental braces, each brace comprising a pressure-sensitive sensor for monitoring the pressure exerted on the teeth;
a data collection unit for collecting data from the pressure-sensitive sensors;
a communication unit for transmitting the analyzed data to a remote server;
a remote server for storing and managing the analyzed data;
a user interface for accessing and displaying the analyzed data to the user.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “set of invisible dental braces”, “pressure sensitive sensor”, “data collection unit”, “data analysis unit”, “communication unit”, “remote server”, and “user interface as recited in Claim 2 are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Claim 2 is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Claim 2 is not integrated into a practical application under the 2019 PEG.
Accordingly, Claim 2 is directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claim 2 includes additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
This claim requires the additional elements of: “set of invisible dental braces”, “pressure sensitive sensor”, “data collection unit”, “data analysis unit”, “communication unit”, “remote server”, and “user interface as recited in Claim 2.
The additional elements of the “set of invisible dental braces”, “pressure sensitive sensor”, “data collection unit”, “data analysis unit”, “communication unit”, “remote server”, and “user interface in Claim 2, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “set of invisible dental braces” is described generically on [003] “invisible dental braces have been developed and are widely accepted by orthodontic patients and dentist.” It is also described in [0014] – 0015] as “an invisible dental brace 100 containing a pressure-sensitive sensor.” The “set of invisible dental braces” is shown as “invisible dental brace 100” in Figure 1 and Figure 2.
Per Applicant’s specification, the “pressure sensitive sensor” is described generically in [0014] as “an invisible dental brace 100 containing a pressure-sensitive sensor” and [0009] “said at least one pressure-sensitive sensor may be a force-sensitive sensor and comprises a force-sensitive film, a pressure-sensitive film, a resistive film, a capacitive film or a piezoresistive pressure sensor.” The “pressure sensitive sensor” is shown as “pressure-sensitive sensor 101” in Figure 1.
Per Applicant’s specification and the 112f interpretation above, the “data collection unit” is described generically at paragraph [0061] with “ data collection unit further comprises a wireless receiver for wirelessly receiving data from the pressure-sensitive sensors” and [0060] “a data collection unit for collecting data from the pressure-sensitive sensors.”
Per Applicant’s specification and the 112f interpretation above, the “data analysis unit” is described generically at paragraph [0060] with “a user interface for displaying the recorded wear time and tooth pressure data.”, [0061] “the data analysis unit is configured to generate reports indicating the progress of the orthodontic treatment”, and [0010] “the remote device can be any computing device or system, such as a personal computer, laptop, tablet, mobile device, wearable device, etc.”
Per Applicant’s specification and the 112f interpretation above, the “communication unit” is described generically at paragraph [0060] with “a communication unit for transmitting the analyzed data to a remote server” and [0010] “the remote device can be any computing device or system, such as a personal computer, laptop, tablet, mobile device, wearable device, etc.”
Per Applicant’s specification, the “remote server” is described generically at [0060] as “a communication unit for transmitting the analyzed data to a remote server; a remote server for storing and managing the analyzed data” and [0010] “the remote device can be any computing device or system, such as a personal computer, laptop, tablet, mobile device, wearable device, etc.”
Per Applicant’s specification , the “user interface” is described generically at [0060] – [0061] and [0064] with “a user interface for accessing and displaying the analyzed data to the user”, “wherein the user interface is accessible via a mobile application”, and “a user interface for displaying the recorded wear time and tooth pressure data.” It is shown in the computer screen drawing in Figure 2.
Accordingly, in light of Applicant’s specification, the claimed terms “set of invisible dental braces”, “pressure sensitive sensor”, “data collection unit”, “data analysis unit”, “communication unit”, “remote server”, and “user interface are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “set of invisible dental braces”, “pressure sensitive sensor”, “data collection unit”, “data analysis unit”, “communication unit”, “remote server”, and “user interface This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claim 2 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatuses of Claim 2 is directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claim 2 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Claim 2 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claim 2 applies an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claim 2 amounts to significantly more than the abstract idea itself. Accordingly, Claim 2 is not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shanjani et. al., (United States Patent Application Publication US 2018/0000563 A1), hereinafter Shanjani.
Regarding Claim 2, Shanjani discloses A system of invisible dental braces equipped with pressure-sensitive sensors (Fig 1A – 1D, Fig 6B; [Abstract]), comprising:
a set of invisible dental braces (Fig 2; “first orthodontic appliance” and “second orthodontic appliance”; Fig 15), each brace comprising a pressure-sensitive sensor (Fig 1A – 1D, Fig 6B; [0195] “A monitoring device can include a single force and/or pressure sensor, or a plurality of force and/or pressure sensors.”; Fig 15; [0196] “The device 1500 includes a plurality of pressure and/or force sensors 1504”) for monitoring the pressure exerted on the teeth ([0196] “…to measure force and/or pressure between an intraoral appliance 1502 and the patient's teeth.”; Fig 15);
a data collection unit for collecting data from the pressure-sensitive sensors ([0011] “data may be stored in physical memory on the monitoring apparatus (e.g., the ECI)…”); [0010] “record sensor data…”; Fig 5);
a data analysis unit for analyzing the collected data to determine the effectiveness of the orthodontic treatment (Fig 5; Fig 40; [0259] “The application software may generate displays, including graphs, and may look for patterns in the data to improve accuracy/specificity/sensitivity of the compliance data…post events such as "LOW COMPLIANCE," "HIGH COMPLIANCE,"; [0004] “Extended removal of the
appliance, for any reason beyond what is recommended, may interrupt the treatment plan and lengthen the overall period of treatment.”)(Examiner notes that a metric of effectiveness of the orthodontic treatment can be whether or not the patient wears the appliance enough, thereby not requiring a lengthening of their treatment due to ineffective tooth movement during the allotted time.).
a communication unit for transmitting the analyzed data to a remote server ([0221] “…step 1930…sensor data…optionally transmitted to a remote device…cloud computing server, or the like. Step 1930…wireless or wired communication methods…”);
a remote server ([0221] “a remote device…cloud computing server, or the like…”) for storing and managing the analyzed data ([0260] “…data history and data analysis can be hosted on a remote server…upload and download data to and from this server”);
a user interface ([0230] “a set of user interface input and output devices 2218”; Fig 40) for accessing and displaying the analyzed data to the user ([0086] “…a user interface for an application program…coordinate data transfer and/or analysis and/or compliance monitoring”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 3 - 7 are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani in view of Evans et. al (United States Patent Application Publication US 2021/0085436 A1), hereinafter Evans, further in view of Kumra Orthodontics “What are Invisalign Refinements and Why Do You Need Them?”, hereinafter Kumra Orthodontics.
Regarding Claim 1, Shanjani discloses A method for management and distribution of invisible dental brace containing pressure-sensitive sensors ([Abstract]; Fig 15) comprising the steps of:
providing an invisible dental brace by a manufacturing and distribution facility to a dentist ([0233] “Scanner 2220 includes any means for obtaining a digital representation…of a patient’s teeth)…which can be obtained…from treating professional, such as an orthodontist...providing digital representation to data processing system 2200…”, “Fabrication system 2222 fabricates appliances 2223 based on a treatment plan, including data set information receive from data processing system 2200.”) wherein at least one pressure-sensitive sensor (Fig 15; [0196] “… a plurality of pressure and/or force sensors 1504”) and a chip ([0010] “Electronic Compliance Indicator” (ECI)…data logger”; “monitoring device 300”; Fig 15 “electronics and logger”; [0196] “controller 1506 can include components…process the sensor data…transmit…”) are fixedly secured onto the invisible dental brace (Fig 15; [0196] “The device 1500 includes a plurality of pressure and/or force sensors 1504”), wherein said at least one pressure-sensitive sensor is configured to generate a sensor signal related to wearing time of the invisible dental brace ([0008]; [0196] “plurality of pressure and/or force sensors 1504…generate sensor data indicative of the pressure and/or force between the appliance 1502 and the patient's teeth.”, “controller 1506…process the sensor data to determine whether the appliance 1502 is being worn.”)(Examiner notes that the sensor signal from the pressure sensor is used by the electronics of the monitoring device to determine if the device is being worn, therefore, the sensor data is related to that analysis of wearing time.) and a pressure applied by teeth of an orthodontic patient ([0196] “…to measure force and/or pressure between an intraoral appliance 1502 and the patient's teeth.”; Fig 15),
writing additional information, including an initial time of wearing, into the chip ([0140] “the stored data can be associated with a timestamp generated by the clock 308 (e.g., a real-time clock or counter).”)(Examiner notes that the timestamp could start when the appliance is first worn.),
applying the invisible dental brace to the teeth of the orthodontic patient by the dentist (Fig 2, “Apply a first orthodontic appliance to a patient’s teeth…”);
transmitting of a data, including the sensor signal ([0141] “the data stored in the memory”) , through wire or a wireless communication technology to a remote device during the usage of the invisible dental brace by the patient ([0141] “The monitoring device 300 may include a communication unit 310 configured to transmit the data stored in the memory ( e.g., sensor data and/or processing results) to a remote device. The communication unit 310 can utilize…wired or wireless communication methods (e.g., RFID…etc.)”); and
processing the data by a specifically designed software or application program of the remote device for the dentist to modify the prescribed plan of orthodontic treatment in a real-time manner based on the data ([0112] “the sensing data provided by the monitoring apparatuses…used as feedback to modify parameters of an ongoing orthodontic treatment, also known as adaptive closed-loop treatment planning.”; [0242] “The data can then be displayed on the smartphone or other display medium using custom applications software…patient and/or orthodontist may be able to download…”), and based on a modified prescribed plan of orthodontic treatment ([0112] “the sensing data…used as feedback to modify parameters of an ongoing orthodontic treatment, also known as adaptive closed-loop treatment planning.”).
Shanjani does not specifically disclose wherein an identification number regarding the invisible dental brace is written into the chip; writing additional information, including the name of the orthodontic patient wearing the invisible dental brace, into the chip by a read-write device provided by the manufacturing and distribution facility to the dentist; writing further information into the chip by the read-write device, including special conditions that occur during applying the invisible dental brace to the teeth of the orthodontic patient; and based on a modified prescribed plan of orthodontic treatment, an order of a new invisible dental brace is delivered to the manufacturing and distribution facility to initiate a manufacture of the new invisible dental brace. Shanjani does broadly disclose that the orthodontic appliances are fabricated based on a treatment plan ([0233] “Fabrication system 2222 fabricates appliances 2223 based on a treatment plan, including data set information received from data processing system 2200…”, and that the treatment plan can be modified based on sensor data ([0112] “sensing data…closed-loop treatment planning”)
Evans teaches a teeth-mounted oral care mouthpiece appliance with patient-specific information that can be written (and re-written) into an RFID chip on the mouthpiece that can be transmitted to an RFID reader. Specifically for Claim 1, Evans teaches wherein an identification number regarding the invisible dental brace is written into the chip ([0112] “the oral insert may have an NFC/RFID chip…”; [0135] “This NFC/RFID chip…track and store product usage information such as…mouthpiece serial number and production date…”);
writing additional information, including the name of the orthodontic patient wearing the invisible dental brace ([0135] “NFC/RFID chip may also be used to track and store product usage information such as a unique patient identification information…”)(Examiner notes that “unique patient identification information” is being written to the memory, and including the name of the patient is being interpreted as the identification/additional information would be connected/associated with the patient’s name in order to identify the patient. A patient’s name can be associated with “unique patient identification information”, in order to specify the patient’s identity.) into the chip by a read-write device provided by the manufacturing and distribution facility to the dentist ([0135] “([0135] “…include re-writable and/or non-rewritable memory…store setting information for a particular user…”, “this information may be changed or re-written at the end of every use…”);
writing further information into the chip by the read-write device, including special conditions that occur during applying the invisible dental brace to the teeth of the orthodontic patient ([0135] “NFC/RFIC chip…track and store product usage information…”, “include re-writable and/or non-rewritable memory…store setting information for a particular user…”, “this information may be changed or re-written at the end of every use…”)
transmitting of a data, including the sensor signal, identification number, additional information, and further information ([0135] “The NFC/RFID chip in the mouthpiece may store patient-specific data… that may be transmitted to a NFC/RFID reader in the base station…”)
Shanjani and Evans both disclose oral care mouthpieces with RFID-compatible electronics: Shanjani with “dental appliances” and [0141] “The monitoring device 300 may include a communication unit 310…can utilize any suitable communication method, such as wired or wireless communication methods (e.g., RFID…)”; Evans with an oral insert with an RFID re-writable chip and an RFID reader. Evans provides a motivation to combine at [0112] with “an oral insert may have an identification tag that has a distinct physical or mechanical characteristic that can be detected or sensed by an identification tag reader in the handle so that the base station can distinguish a first oral insert from a second oral insert.“ A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that writing identifying information such as patient name and identification number would be useful for identifying a mouthpiece for a specific person, whether for personal use to avoid using someone else’s aligner, or for material handling at the orthodontist office or manufacturer to differentiate aligners from different patients. It would have been predictable to use the RFID information writing taught by Evans in any similar mouthpiece with an RFID-compatible chip, as it would continue to operate with the function of pairing identifying information about the patient and appliance with the appliance.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the instrumented “dental appliances” with writable storage and RFID capabilities disclosed in Shanjani with the assigned identification information and writable setting information written to a mouthpiece’s RFID chip taught by Evans, creating a single orthodontic dental appliance with sensors that can store and transmit personal patient identifying information with RFID in order to tie an aligner to a particular patient.
Evans does not teach and based on a modified prescribed plan of orthodontic treatment, an order of a new invisible dental brace is delivered to the manufacturing and distribution facility to initiate a manufacture of the new invisible dental brace
Kumra Orthodontics teaches that additional trays can be fabricated due to changes in the treatment plan based on unsatisfactory tooth movement over the course of orthodontic alignment treatment with sets of invisible aligners (as with Invisalign). Specifically for Claim 1, Kumra Orthodontics teaches and based on a modified prescribed plan of orthodontic treatment, an order of a new invisible dental brace is delivered to the manufacturing and distribution facility to initiate a manufacture of the new invisible dental brace ([Page 2, “What are Invisalign Refinements”? Section”, Paragraph 1] “Refinements for Invisalign are minute adjustments…made to your aligners by your dentist while you are undergoing treatment. When the teeth are not being aligned properly…necessary to make adjustments”; [Page 2, “How do Invisalign Refinements Work?” Section, Paragraph 1] “Refinement aligners are identical to the regular Invisalign trays, except…fabricated according to your specific needs throughout the treatment process”)
Kumra Orthodontics provides a motivation to combine at [Page 2, “How do Invisalign Refinements Work?” Section, Paragraph 1] with “Because these digitally produced aligners are created based on molds of your teeth, a specific treatment plan may be tailored to the needs of each patient.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that fabricating additional aligner appliances (Kumra Orthodontics’ taught “refinement” aligners) as a result of data (or observation) that the teeth movement is not satisfactory would be useful for implementing a personalized treatment plan for users, in accordance with Shanjani’s disclosed “closed-loop treatment planning”.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Shanjani’s disclosed instrumented “dental appliances” fabricated according to a treatment plan that can change based on sensor data per “close-loop treatment planning” with Kumra Orthodontics’ taught “refinement” aligners fabricated after treatment begins per a changed treatment plan, creating a single orthodontic system with aligners that are fabricated at multiple times in the treatment process based on teeth position sensor data, for a personalized orthodontic treatment.
Regarding Claim 3, Shanjani in view of Evans, further in view of Kumra Orthodontics discloses as described above, The system of claim 1. For the remainder of Claim 3, Shanjani discloses wherein the pressure-sensitive sensors [0196] “The device 1500 includes a plurality of pressure and/or force sensors 1504”) are embedded within the invisible dental braces (Fig 15, [0148] “…the monitoring device…physically integrated with the intraoral appliance by encapsulating, embedding…the monitoring device with the appliance.)
Regarding Claim 4, Shanjani in view of Evans, further in view of Kumra Orthodontics discloses as described above, The system of claim 1. For the remainder of Claim 4, Shanjani discloses wherein the pressure-sensitive sensors are configured to measure the pressure exerted on individual teeth ([0194] “measurement data may be indicative of the force...between the appliance and the intraoral tissue, such as one or more of the patient’s teeth,”; [0196])
Regarding Claim 5, Shanjani in view of Evans, further in view of Kumra Orthodontics discloses as described above, The system of claim 1. For the remainder of Claim 5, Shanjani discloses wherein the data collection unit further comprises a wireless receiver for wirelessly receiving data from the pressure-sensitive sensors ([0141] “…communication unit 310 includes a receiver for receiving data from the remote device.”, “…monitoring device 300…include a communication unit 310 to transmit the data store…(e.g. sensor data and/or processing results…”)
Regarding Claim 6, Shanjani in view of Evans, further in view of Kumra Orthodontics discloses as described above, The system of claim 1. For the remainder of Claim 6, Shanjani discloses wherein the data analysis unit ([0007] “one or more processors…operably coupled to the sensor(s) and configured to process the sensor data…”) is configured to generate reports ([0247] “…determine a more accurate 'worn' or 'not worn' metric that may be output by the ECI or by software/firmware/hardware in communication with the ECI ( e.g., from an application software running on a smartphone, etc.).”)(Examiner notes that results are reported to the user.) indicating the progress of the orthodontic treatment ([0007] “…enabling electronic monitoring of patient compliance with a prescribed course of orthodontic treatment”; [0259] “LOW COMPLIANCE”, “HIGH COMPLIANCE”)
Regarding Claim 7, Shanjani in view of Evans, further in view of Kumra Orthodontics discloses as described above, The system of claim 1. For the remainder of Claim 7, Shanjani discloses wherein the user interface is accessible via a mobile application ([0242] “…data can then be displayed on the smartphone or other display medium using custom applications software, which the patient and/or orthodontist may be able to download for execution on the smartphone or other mobile device…”).
Claims 8 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shanjani in view of Denny et. al. (United States Patent Application Publication US 2023/0410961 A1), hereinafter Denny.
Regarding Claim 8, Shanjani discloses A system of invisible dental braces (Fig 1A – 1D, Fig 6B; [Abstract]) comprising:
a set of invisible dental braces (Fig 2; “first orthodontic appliance” and “second orthodontic appliance”; Fig 15), each brace comprising pressure-sensitive sensors embedded within (Fig 1A – 1D, Fig 15; (Fig 15, [0148] “…the monitoring device…physically integrated with the intraoral appliance by encapsulating, embedding…the monitoring device with the appliance.);
a chip([0010] “Electronic Compliance Indicator” (ECI)…data logger”; “monitoring device 300”; Fig 15 “electronics and logger”; [0196] “controller 1506 can include components…process the sensor data…transmit…”) ) for recording wear time ([0008]; [0133] “…provide data indicative of whether the appliance is being worn, the amount of time the appliance is worn…”) and tooth pressure data ([0194] “measurement data may be indicative of the force...between the appliance and the intraoral tissue, such as one or more of the patient’s teeth.”; [0196]);
an online platform for remote access of recorded data (Fig 43 “upload data to cloud”; [0142] “the remote device can be a part of or connected to a cloud computing system ("in the cloud")”).
a database for storing additional patient data including dental impressions and treatment plans ([0322] “positive or negative models of the patient's teeth generated by impression, scanning, and the like.”; [0233] “providing the digital representation to data processing system 2200”, “based on a treatment plan, including data set information received from data processing system 2200”; [0232] “The program modules discussed herein are typically stored in storage subsystem 2206.”).
Shanjani does not specifically disclose a secure online platform. Shanjani does broadly disclose that its sensor data can be transferred to a remote device that can be [0142] “…a part of or connected to a cloud computing system ("in the cloud")”. It does not specifically say that it is secure.
Denny teaches a secure cloud server for oral care health information. Specifically for Claim 8, Denny teaches a secure online platform ([0022] “server or cloud platform may store information associated with patient history…in a secure manner and also provide a comprehensive view of the patient's treatment history at any time using a suitable browser”).
Denny provides a motivation to combine at [0022] with “server or cloud platform may store information associated with patient history…in a secure manner and also provide a comprehensive view of the patient's treatment history at any time using a suitable browser”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that a cloud server can be “secure”, and is an option for storing patient data, including that of sensors.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the broadly disclosed “cloud computing system” that receives oral sensor data with the secure online cloud server than receives dental care data taught by Denny, creating a single orthodontic alignment system with data visible for review by users on a secure online server.
Regarding Claim 9, Shanjani in view of Denny discloses as described above, The system of claim 8. For the remainder of Claim 9, Shanjani discloses wherein the pressure-sensitive sensors are capable of continuously monitoring the forces exerted on the teeth ([0239] “…the apparatus can acquire data…at a continuous 10 min intervals, and store the data in the memory…)”; [0286] “The appliance electronics can comprise a power source…energy for continuous operation.”; [0194]).
Regarding Claim 10, Shanjani in view of Denny discloses as described above, The system of claim 8. For the remainder of Claim 10, Shanjani discloses wherein the chip is capable of wirelessly transmitting the recorded wear time ([0008]; [0133] “…provide data indicative of whether the appliance is being worn, the amount of time the appliance is worn…”; [0141] “…monitoring device 300 may include a communication unit 310 configured to transmit the data…can utilize…wireless communication methods”) and tooth pressure data ([0194] “measurement data may be indicative of the force...between the appliance and the intraoral tissue, such as one or more of the patient’s teeth.”; [0196]) to the online platform ([0141] “transmit…to a remote device”; [0142] “remote device…part of or connected toa cloud computing system”).
Shanjani does not specifically disclose the secure online platform.
Denny teaches the secure online platform ([0022] “server or cloud platform may store information associated with patient history…in a secure manner and also provide a comprehensive view of the patient's treatment history at any time using a suitable browser”).
The motivation for Claim 10 to combine Shanjani with Denny is the same as that described in more detail in Claim 8. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the broadly disclosed “cloud computing system” that receives oral sensor data with the secure online cloud server than receives dental care data taught by Denny, creating a single orthodontic alignment system with data visible for review by users on a secure online server.
Regarding Claim 11, Shanjani in view of Denny discloses as described above, The system of claim 8, wherein the secure online platform. For the remainder of Claim 11, Shanjani discloses wherein the online platform (Fig 43 “upload data to cloud”; [0142] “the remote device can be a part of or connected to a cloud computing system ("in the cloud")”) further comprises a user interface for displaying the recorded wear time and tooth pressure data ([0242] “The data can then be displayed on the smartphone or other display medium using custom applications software, which the patient and/or orthodontist may be able to download for execution on the smartphone or other mobile device.”’; [0141] “The remote device can be any computing device or system, such as a mobile device ( e.g., smartphone)”)
Regarding Claim 12, Shanjani in view of Denny discloses as described above, The system of claim 8. For the remainder of Claim 12, Shanjani discloses wherein the database further comprises monitoring the progress of orthodontic treatment ([0112] “the sensing data provided by the monitoring apparatuses described herein may be used as feedback to modify parameters of an ongoing orthodontic treatment, also known as adaptive closed-loop treatment planning.”; [Fig 22 “user interface”)
Shanjani does not specifically disclose a treatment progress tracker.
Denny teaches wherein the database further comprises a treatment progress tracker for monitoring the progress of orthodontic treatment ([0048] “The appliances may be provided with a remote monitoring kit to assist the treating professional in tracking the progress of treatment.”; [0022] “a server or cloud platform may store information associated with patient history (i.e., a DHR)…”; [0050] “If the patient’s teeth do not progress as planned…revise the treatment plan in the DHR…”; Fig 3).
Denny provides a motivation to combine at [0050] with “Because a patient's teeth may respond differently than originally expected, the treating professional may wish to evaluate the patient's progress during the course of treatment.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having a remote monitoring kit would be useful for evaluating a patient’s progress during treatment and responsively changing the treatment plan, leading to better orthodontic patient outcomes.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Shanjani’s broadly disclosed custom applications software on a remove device (such as a cell phone) user interface that receives and displays aligner sensor data about teeth with the specific tracking of progress of oral care treatment by a treating professional using a “remote monitoring” interface, taught by Denny, creating a single orthodontic system that submits sensor data to a user interface that a treating professional uses to track the progress of oral care treatment.
Regarding Claim 13, Shanjani in view of Denny discloses as described above, The system of claim 8. For the remainder of Claim 13, Shanjani discloses wherein the pressure-sensitive sensors are capable of detecting forces exerted on the teeth ([0194] “The monitoring device can…determine whether the measured force and/or pressure are within the expected range corresponding to the patient wearing the appliance.”)(Examiner notes that a force measured that is indicative of a patient not wearing the appliance can be considered to be abnormal, since the patient is supposed to be wearing the appliance (and having tooth measurements consistent with wearing it)), and generating alerts to the orthodontist ([0259] “The application software…may post events such as "LOW COMPLIANCE," "HIGH COMPLIANCE," etc). Shanjani does not specifically disclose detecting abnormal forces exerted on the teeth. However, Shanjani can generally detect any forces on the teeth, which would also include any both non-specifically normal and abnormal forces.
Regarding Claim 14, Shanjani in view of Denny discloses as described above, The system of claim 8. For the remainder of Claim 14, Shanjani discloses wherein the chip further comprises a memory (Fig 3A “Memory 304”) for storing the recorded wear time ([0258] “…the data may be stored in physical memory on the ECI”; [0008]; [0133] “…data…the amount of time the appliance is worn…”) and tooth pressure data ([0194] “measurement data may be indicative of the force...between the appliance and the intraoral tissue, such as one or more of the patient’s teeth.”; [0196]; Fig 3A “Memory 304”)
Regarding Claim 15, Shanjani in view of Denny discloses as described above, The system of claim 8, wherein the secure online platform. For the remainder of Claim 15, Shanjani discloses further comprises a communication module (Fig 3A; “communication unit 310”) for facilitating communication between the orthodontist and the patient ([0110] “user interface to augment communication between the ECI and the device, and may provide feedback to the user (e.g., patient) and/or technician, physician, dentist, orthodontist, or other medical/dental practitioner…”)(Examiner that patient data from the patient is communicated to the orthodontist by way of sending to data information from the patient-used device to the orthodontist.)
Regarding Claim 16, Shanjani in view of Denny discloses as described above, The system of claim 8. For the remainder of Claim 16, Shanjani discloses wherein the pressure-sensitive sensors are capable of detecting the alignment of the teeth ([0319] “The movement of teeth due to orthodontic forces can also be measured…”) and generating alignment data for analysis by the orthodontist ([0319] “..movement of teeth…monitoring the stiffness of a tooth-PDL structure to which orthodontic forces are being applied by the appliance”; [0110] “user interface to augment communication between the ECI and the device, and may provide feedback to the user (e.g., patient) and/or technician, physician, dentist, orthodontist, or other medical/dental practitioner…”; [0112] “the sensing data…modify parameters of an ongoing orthodontic treatment, also known as adaptive closed-loop treatment planning.”)
Regarding Claim 17, Shanjani in view of Denny discloses as described above, The system of claim 8. For the remainder of Claim 17, Shanjani discloses wherein the chip ([0010] “Electronic Compliance Indicator” (ECI)…data logger” “monitoring device 300”) further comprises a power source for powering the pressure-sensitive sensors (Fig 3A, “power source 316” powering “sensor(s) 306”; [0286] “The appliance electronics can comprise a power source such as a battery to store energy for continuous operation.”) and the recording of wear time ([0008]; [0133] “…provide data indicative of whether the appliance is being worn, the amount of time the appliance is worn…”) and tooth pressure data ([0133] “…data related to… interaction between the appliance and the intraoral cavity…(…force and/or pressure applied by the appliance to intraoral tissues.)”)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Matov et. al., (United States Patent Application Publication US 2013/0204583 A1) teaches a computing device and dental appliance that identifies forces placed on teeth during orthodontic tooth realignment throughout treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791