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 .
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 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.
Status of Claims
Claims 86-105 are pending and under consideration for patentability; claims 1-85 were cancelled and claims 86-105 were added as new claims via a Preliminary Amendment dated 19 June 2025.
Information Disclosure Statement
The Information Disclosure Statement submitted on 22 October 2025 has been acknowledged and considered by the Examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 86-89, 92-99, and 102-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,272,433 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite methods of predicting adoption of a therapy, including receiving data associated with a prescribed treatment plan, receiving data associated with a likelihood that an individual will adopt the prescribed treatment plan, generating a personalized treatment adoption plan, receiving feedback associated with the personalized treatment adoption plan, and generating recommendations based on the feedback. A brief, but non-exhaustive matching of the pending claims with the issued claims is provided via the table below. The Examiner has expanded upon the analysis for independent claim 86 for clarification.
U.S. Application No. 19/074,251
Pending Claims
U.S. Patent No. 12,272,433 B2
Issued Claims
86.
A method comprising:
receiving data associated with a prescribed treatment plan for an individual to use a respiratory therapy device;
receiving data associated with a likelihood that the individual will adopt or complete the prescribed treatment plan;
based at least in part on the prescribed treatment plan and the data associated with the likelihood of the individual adopting or completing the prescribed treatment plan, generating a personalized treatment adoption plan for the individual, the personalized treatment adoption plan including a recommendation to use a mandibular repositioning device (MRD);
responsive to implementation, by the individual, of the personalized treatment adoption plan, receiving feedback associated with the personalized treatment adoption plan; and
based at least in part on at least a portion of the feedback, generating (i) a recommendation to continue implementing the personalized treatment adoption plan, (ii) a recommendation to implement the prescribed treatment plan, or (iii) a modified personalized treatment adoption plan
1.
A method comprising:
receiving a prescribed treatment plan for an individual;
receiving data associated with the individual;
using a machine learning adoption prediction algorithm to process at least a portion of the received data to determine a likelihood that the individual will adopt the prescribed treatment plan;
based at least in part on (i) the prescribed treatment plan and (ii) the determined likelihood that the individual will adopt the prescribed treatment plan, generating a personalized treatment adoption plan for the individual;
responsive to implementation, by the individual, of the personalized treatment adoption plan, receiving feedback associated with the personalized treatment adoption plan; and
based at least in part on (i) the personalized treatment adoption plan and (ii) the feedback, generating a modified personalized treatment adoption plan.
5.
The method of claim 2, wherein the prescribed treatment plan includes a first recommendation for the individual to begin treatment using a respiration device and the modified version of the prescribed treatment plan includes a second recommendation for the individual to begin treatment using a mandibular repositioning device.
2.
The method of claim 1, wherein responsive to the machine learning adoption prediction algorithm determining that the likelihood the individual will adopt the prescribed treatment plan satisfies a first threshold, the generated personalized treatment adoption plan for the individual includes a modified version of the prescribed treatment plan.
87
1, 13, 14
88
14
89
14
92
4
93
4
94
10
95
12
96
1, 2, 5
97
1, 13, 14
98
14
99
14
102
4
103
4
104
10
105
12
Claims 90, 91, 100, and 101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 12,272,433 B2 in view of Yu et al. (WO 2016/000040 A1, with citations made to corresponding US Publication 2019/0232013 A1). The Examiner notes that the Yu reference shares the same assignee with the instant application.
Regarding claims 90, 91, 100, and 101, the ‘433 patent does not explicitly recite wherein the sensor includes one of the sensors recited in claims 90/100 and wherein the sensor is positioned in a wearable device as recited in claims 91/101. However, Yu also describes a method comprising increasing the compliance of a user with a medical device ([0021]), including receiving patient feedback ([0603]) and using a flow sensor positioned in a wearable device worn by the user ([0187]). As Yu is also directed towards improving patient compliance with a treatment plan and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a sensor similar to that described by Yu when using the method recited in the ‘433 patent, as doing so advantageously allows the resulting method to obtain quantitative data regarding the effectiveness of the medical device being used.
Allowable Subject Matter
Claims 86-105 would be allowable if the double patenting rejections noted above were overcome.
The following is a statement of reasons for the indication of allowable subject matter.
The prior art of record does not disclose or suggest a method of predicting the adoption of a therapy comprising, (i) prior to implantation of a therapy, receiving data associated with a prescribed treatment plan and data associated with a likelihood that an individual will adopt or complete the prescribed treatment plan, generating a personalized treatment adoption plan based on the likelihood that the individual will adopt the prescribed treatment plan, and (ii) responsive to implementation of the therapy, receiving feedback regarding the adoption of the personalized treatment adoption plan and generating a recommendation to continue implementing the personalized treatment adoption plan, generating a recommendation to implement the prescribed treatment plan, or generating a modified personalized treatment adoption plan.
Analogous prior art includes Levings et al. (US 2017/0209657 A1) and Moore et al. (US 2018/0303412 A1).
Levings describes a method comprising receiving user data, determining the likelihood that a user will adopt a prescribed treatment plan ([0040]: “the method may include analysing in a processor data relating to respiratory therapy delivered to the patient via a respiratory pressure therapy device to generate data representing a compliance prediction about the progress of the respiratory therapy”), and generating a personalized treatment adoption plan for the user ([0040]: “the method may include selecting an action with the processor to improve the respiratory therapy based on the data representing the compliance prediction”). However, Levings performs the above steps only after implementing the therapy, as opposed to generating the personalized treatment adoption plan prior to implantation of the therapy. Although the teachings of Levings can be interpreted to read on the limitations which occur “responsive to implementation,” Levings fails to teach or suggest the prior limitations, which occur prior to the implementation.
Moore also describes a method of receiving user data, generating a treatment plan, and updating the treatment plan based on user feedback (figures 3 and 4, regarding data collection and generating a coaching process). Although Moore describes a series of pre-screening steps (figure 2), which may be considered as occurring prior to implantation of a therapy, Moore does not account for the likelihood that the user will adopt the prescribed treatment plan and does not generate a personalized treatment adoption plan or a modified personalized treatment adoption plan based on the user’s level of compliance.
Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel, can be reached by telephone at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
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