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 .
Prosecution History Summary
Claims 1-13 are pending.
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 1-13 are 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.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process (claims 1-13). Accordingly, claims 1-13 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A method of determining compliance with a treatment plan, comprising the steps of:
-parsing one or more aspect of a treatment plan;
-sensing one or more physical feature of a medical device using one or more sensor separately provided from the medical device, the sensed feature(s) corresponding to the one or more aspect of the treatment plan;
-determining adherence to each parsed aspect of the treatment plan based on the sensed feature(s) of the medical device;
-determining compliance with the treatment plan based on the determination(s) of adherence of the parsed aspect(s) of the treatment plan.
Examiner states submits that the foregoing underlined limitations constitute: a “mental process” because analyzing a treatment plan and determining adherence and compliance to that treatment plan can all be performed in the human mind.
Accordingly, the claim recites at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether
the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP
§$2106.04(1D(A)(2), it must be determined whether any additional elements in the claim beyond
the abstract idea integrate the exception into a practical application in a manner that imposes a
meaningful limit on the judicial exception. The courts have indicated that additional elements
merely using a computer to implement an abstract idea, adding insignificant extra solution
activity, or generally linking use of a judicial exception to a particular technological environment
or field of use do not integrate a judicial exception into a “practical application.” MPEP
§2106.05(1(A).
In the present case, the additional limitations beyond the above-noted at least one abstract
idea recited in the claim are as follows (where the bolded portions are the “additional
limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A method of determining compliance with a treatment plan, comprising the steps of:
-parsing one or more aspect of a treatment plan;
-sensing one or more physical feature of a medical device using one or more sensor separately provided from the medical device, the sensed feature(s) corresponding to the one or more aspect of the treatment plan (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 58-60);
-determining adherence to each parsed aspect of the treatment plan based on the sensed feature(s) of the medical device;
-determining compliance with the treatment plan based on the determination(s) of adherence of the parsed aspect(s) of the treatment plan.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID(A)(2).
The remaining dependent claim limitations not addressed above fail to integrate the
abstract idea into a practical application as set forth below:
Claim 2: The claim specifies aspect specify aspect of treatment plan, which further narrows the abstract idea.
Claim 3, 5-6: The claim specifies compliance determination, which further narrows the abstract idea.
Claim 4: The claim specifies the sensed feature, which does no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the use of at least one abstract idea is performed (see MPEP 2106.05(h)).
Claim 7: The claim specifies further updating the treatment plan based on compliance determination, which further narrows the abstract idea.
Claim 8: The claim specifies further modifying compliance determination, which further narrows the abstract idea.
Claim 9: The claim specifies further providing a new medical device based on compliance determination, which is an insignificant extra-solution activity (see MPEP 2106.05(g)).
Claim 10-11: The claim specifies further transmitting compliance to an external device, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 12: The claim specifies further transmitting adherence determination, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 13: The claim specifies further transmitting sensed features of the medical device, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as sensing feature of a medical device e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); parsing treatment plan, determining adherence, determining compliance, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 7 and 10-13, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 10-13 (transmitting), e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); updating the treatment plan based on compliance, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-13 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brawn et al. (U.S. Publication No. 2015/0140502).
As per claim 1, Brawn teaches a method of determining compliance with a treatment plan, comprising the steps of:
-parsing one or more aspect of a treatment plan (Brawn: para. 209; Microprocessor storing information regarding the treatment program and analyzing patient’s usage history, interruptions, etc.);
-sensing one or more physical feature of a medical device using one or more sensor separately provided from the medical device, the sensed feature(s) corresponding to the one or more aspect of the treatment plan (Brawn: para. 239; para. 169; para. 175; The external housing includes position sensor, gyroscope and an accelerometer to determine position of the apparatus.);
-determining adherence to each aspect of the treatment plan based on the sensed feature(s) of the medical device (Brawn: para. 138; para. 154; Use sensors to measure temperature of the apparatus and the patient’s mouth to monitor compliance according to treatment program.);
-determining compliance with the treatment plan based on the determination(s) of adherence of the aspect(s) of the treatment plan (Brawn: para. 138; para. 154; Use sensors to measure temperature of the apparatus and the patient’s mouth to monitor compliance according to treatment program.).
As per claim 2, the method of claim 38 is as described. Brawn further teaches wherein the aspect of the treatment plan corresponds to a wear time of the medical device (Brawn: para. 209; Analyzing patient’s history of use.).
As per claim 3, the method of claim 2 is as described. Brawn further teaches wherein compliance has been determined to have been met when the wear time of the medical device has met or exceeded a threshold (Brawn: para. 590-592).
As per claim 4, the method of claim 1 is as described. Brawn further teaches wherein the sensed feature of the medical device is an amount of time the medical device is located within a storage cavity (Brawn: para. 138; para. 288; para. 156; para. 592; Determining amount of time within the mouth.).
As per claim 5, the method of claim 1 is as described. Brawn further teaches wherein compliance is determined to have been met when adherence is determined to be less than strict adherence (Brawn: para. 571-572).
As per claim 6, the method of claim 1 is as described. Brawn further teaches wherein compliance is determined to have been met when adherence is determined to be strict adherence to one aspect and strict or less than strict adherence to the other aspect (Brawn: para. 575-578).
As per claim 7, the method of claim 1 is as described. Brawn further teaches further comprising the step of updating the treatment plan when compliance is determined to not have been met (Brawn: para. 568; Modifying the orthodontic treatment plan.).
As per claim 8, the method of claim 1 is as described. Brawn further teaches further comprising the step of modifying how compliance is determined based on previous compliance determinations (Brawn: para. 568; Assessing tooth movement from the orthodontic appliance and analyzing result.).
As per claim 9, the method of claim 1 is as described. Brawn further teaches further comprising the step of providing a new or updated medical device based on the compliance determination (Brawn: para. 570; Switching orthodontic appliances based on determining a modification.).
As per claim 10, the method of claim 1 is as described. Brawn further teaches further comprising the step of transmitting the compliance determination to an external device (Brawn: para. 570; Transferring information to an external device.).
As per claim 11, the method of claim 1 is as described. Brawn further teaches further comprising the step of transmitting an aggregate compliance determination to an external device, wherein the aggregate compliance determination corresponds to a plurality of compliance determinations (Brawn: para. 570; Transferring information to an external device.).
As per claim 12, the method of claim 1 is as described. Brawn further teaches further comprising transmitting the adherence determination when compliance has been determined to not have been met (Brawn: para. 178).
As per claim 13, the method of claim 1 is as described. Brawn further teaches further comprising transmitting data corresponding to the sensed one or more feature of the medical device when compliance has been determined to not have been met (Brawn: para. 178).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bradley – U.S. Publication No. 2015/0169845 – Teaches a method for verifying compliance with a dental appliance therapy.
Shajane, et al. – CN 107518952A – Teaches a system for detecting placement of dental aligners for compliance.
Baratier et al. – U.S. Publication No. 2013/0140289 – Teaches a compliance monitoring system for an intraoral appliance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEETAL R. PAULSON whose telephone number is (571)270-1368. The examiner can normally be reached M-F 8am-5pm.
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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3686