DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. In response to the amendment filed 08 October 2025, claims 1-3, 6, 8-12, 14, 15, 18-22, 24-26, 28, 30, 39 and 43 remain pending.
Claim Rejections – 35 USC § 101
3. 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 1-3, 6, 8-12, 14, 15, 18-22, 24-26, 28, 30, 39 and 43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claim 1 recites a method comprising:
(i) responsive to patient input data, producing a patient personalized assessment;
(ii) formulating a customized intervention for the patient based on the patient input data and/or personalized assessment; and
(iii) presenting the patient personalized assessment and/or customized intervention on the display.
The limitations of producing a patient personalized assessment, formulating a customized intervention and/or assessment, and presenting the assessment and/or intervention, as drafted, constitutes a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a system comprising a patient computer system and a server, nothing in the claim elements precludes the steps from practically being performed in the mind. For example, but for the “computer system” and “server” language, “producing”, “formulating” and “presenting” in the context of this claim encompasses a user manually producing the assessment, formulating and delivering the intervention, for example using a pen and paper. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites using a computer system and server to perform the claimed steps. The computer and server in these steps are recited at a high-level of generality (i.e., as a generic computer and server performing generic computer functions of producing an assessment and formulating and presenting an assessment or intervention) such that they amount to no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim further recites an accessory device and/or medicament delivery device, wherein the patient computer system passively communicates with the device via detection of a sound, light, image or motion associated with the device. This accessory device and/or medicament delivery device is recited at a high level of generality, and is involved only in pre-solution data gathering via one of several types of passive communication involving detection of data by the computer system. This amounts to no more than insignificant extra-solution activity in the form of pre-solution data gathering. See MPEP 2106.05(g). The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer and server to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. As noted above, the claim also recites the patient computer system passively communicating with a generic accessory and/or medicament delivery device to obtain data associated with use of the device, which amounts to no more than pre-solution data gathering. See MPEP 2106.05(g). The claim is not patent eligible.
Dependent claims 2, 3, 6, 8-12, 14, 15, 18, 19-22, 24-26, 28, 30, 39 and 43 recite the same abstract idea as in claim 1, and only recite further abstract steps of receiving patient data and displaying information to the patient, performed by the computer system and/or server. Accordingly, these claims do not recite additional limitations sufficient to direct the claimed invention to significantly more.
Claim Objections
4. Claim 1 is objected to because of the following informalities: the claim recites “by via” in line 7. It appears one of these terms should be deleted. The claim also recites in lines 8-9 “medicament delivery by a sensor”. It appears this should recite “medicament delivery device by a sensor”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
5. 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.
6. Claims 1-3, 6, 8-12, 14, 15, 18-20, 24-26, 28, 30, 39 and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klee et al. (US 2018/0318643 A1)
Regarding claim 1, Klee discloses a system for providing personalized self-medication, onboarding, training and improving medication adherence, the system comprising:
an accessory device and/or medicament delivery device (breathing assist device 10 – Par. 158);
a patient computer system (e.g. display device 12 in form of smart phone with display and app – see Fig. 1) comprising at least one processor and at least one memory component and a display, wherein the patient computer system passively communicates with the accessory device and/or medicament delivery device via detection of a sound associated with the accessory device and/or medicament delivery device by a sensor associated with the patient computer system (see Par’s. 164-170, 133 – microphone on device 12, or e.g. attached to user’s chest, records user’s breathing while using device 10, and analyzes the audio signal; this constitutes passive detection of a sound associated with the device); and
a server connected to the patient computer system by a network link the server comprising at least one processor and at least one computer readable medium (remote platform hosting services to provide extended functionality and services – Par. 106, 113, wherein the services may be performed on device 12 or the remote platform), wherein at least one computer readable medium comprises instructions that when executed by at least one processor, cause at least one processor to perform acts comprising:
(i) responsive to patient input data, producing a patient personalized assessment (gather and interpret intelligence about patient – see e.g. Par’s. 154, 216);
(ii) formulating a customized intervention for the patient based on the patient input data and/or personalized assessment; and (iii) presenting the patient personalized assessment and/or customized intervention on the display (Par’s. 105, 216, 228-229 – provide interventions based on patient input data).
Regarding claims 2, 3, 6, 8-12, 14, 15, 18-20, 24-26, 28, 30, 39 and 43, Klee further discloses the patient input data comprises disease state (Par. 216 – disease progression) (as per claim 2),
the patient input data comprises patient disease state information (Par. 216) (as per claim 3),
the patient computer system comprises a network link to a local area network that communicates to the server via an internet connection; optionally wherein the patient computer system is a mobile device that wirelessly communicates with the server via an internet connection (Par. 107) (as per claim 6),
producing a patient personalized assessment comprises producing a personalized assessment of patient training needs and/or patient treatment needs (as per claim 8),
the customized intervention comprises a customized training intervention and/or customized treatment intervention (Par. 72 – customized breathing training) (as per claim 9),
producing a patient personalized assessment comprises producing a personalized assessment of patient emotional needs (e.g. stress/anxiety – Par. 67) (as per claim 10),
the customized intervention comprises a customized training intervention (Par. 72) (as per claim 11),
the patient input data comprises training usage data or comprises treatment progress information (Par. 251 – monitor breathing exercises); and wherein the server comprises a storage device comprising a plurality of motivational element variables stored thereon and wherein the at least one memory component of the server comprises instructions that causes the at least one processor to select, in response to patient input data, one or more motivational element variables from the plurality of motivational element variables to form the motivational element and to present the motivational element on the display (Par. 252) (as per claim 12),
the patient input data is treatment effectiveness data, and further comprising instructions to cause the at least one processor to present on the display a motivational element to the patient in response to treatment effectiveness data (Par’s. 251-252) (as per claim 14),
the patient computer system actively communicates with an accessory device and/or a medicament delivery device via a wired or wireless connection (breathing device 10 – see Fig. 1, Par. 106) (as per claim 15),
the accessory device and/or medicament delivery device comprise at least one sensor (Par. 107) (as per claim 18),
the at least one sensor detects operation of the accessory device and/or medicament delivery device (Par. 108) (as per claim 19),
the patient input data comprises operation of the accessory device and/or medicament delivery device, or comprises treatment progress information (Par. 108) (as per claim 20),
the server comprises a storage device comprising a plurality assessment variables stored thereon and wherein the at least one memory component of the server comprises instructions that causes the at least one processor to select, in response to patient input data, a combination of assessment variables from the plurality to form the personalized assessment and to present the personalized assessment on the display and (ii) a plurality of training variables stored thereon and wherein the at least one memory component of the server comprises instructions that causes the at least one processor to select, in response to patient input data, a combination of intervention variables from the plurality of intervention variables to form the customized intervention and to present the personalized assessment on the display (Par’s. 114, 216, 229, 244 – present assessment based on intervention variables such as situation and triggers, and assessment variables such as such as frequency and use purpose) (as per claim 24),
the server comprises a storage device (Par. 106, 113) (as per claims 25 and 26),
the at least one sensor is a physiological sensor integral to or connected to an accessory device that comprises circuitry to convey information to the server directly through a wireless connection, or indirectly through the patient computer system or delivery device (breathing sensor 10 - Par. 108) (as per claim 28),
at least one sensor that communicates with the patient computer system, accessory device and/or delivery device (Par. 108) (as per claim 30),
the at least one sensor detects errors of mechanical operation of the accessory device and/or delivery device or errors in patient use of the accessory device and/or delivery device (errors in use of breathing device – Par. 138) (as per claim 39), and
the at least one sensor is a geolocation sensor that detects a patient's location during use of an accessory device and/or delivery device; or wherein the at least one sensor comprises a temporal sensor that detects a time at which a patient uses the accessory device and/or delivery device (Par. 57) (as per claim 43).
Claim Rejections - 35 USC § 103
7. 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.
8. Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Klee et al. (US 2018/0318643 A1) in view of Chidambaran et al. (US 2012/0251993 A1).
Regarding claim 21 and 22, Klee does not appear to explicitly disclose the server comprises a storage device onto which training videos or training text is stored and wherein the at least one memory component comprises instructions causing the at least one processor of the server to present the training video(s) or training text on the display (as per claim 21), and the server records access and/or presentation of the training videos or training text to the display; and wherein the at least on memory component causes the at least one processor to present a motivational element on the display in response to access of training video(s) or training text (as per claim 22). However, Chidambaran discloses a similar system for providing health interventions to a patient that includes personalized training videos (see Par. 28). It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the teachings of Klee by providing interventions and motivational elements in the form of training videos, as taught by Chidambaran. Such a modification would involve combining prior art elements according to known methods to yield predictable results.
Response to Arguments
9. Applicant's arguments filed 08 October 2025 have been fully considered but they are not persuasive.
Regarding the section 101 rejection, Applicant argues that the recitation of an accessory device and/or medicament delivery device, wherein the computer system passively communicates with the device, recites specific structural components that integrates any abstract idea into a practical application. This is not persuasive. As detailed in the rejection above, this accessory device and/or medicament delivery device is recited at a high level of generality, and is involved only in pre-solution data gathering via any of a number of generic types of signals by the patient computer system. This amounts to no more than the addition of insignificant extra-solution activity to the judicial exception, and is not indicative of integration into a practical application. See MPEP 2106.05(g).
Regarding the section 102 rejection, Applicant argues that Klee does not disclose the newly added feature of the patient computer system passively communicating with the accessory or medicament delivery device via detection of sound, light, image or motion. However, as detailed above Klee discloses this passive communication of sound associated with the device, for example by using a microphone on the computer system or attached to the user’s chest to obtain breathing sounds associated with use of the device 10. Klee also discloses at Par. 133 the passive communication may be via an accelerometer attached to the belly to passively observe movement associated with use of the device.
Conclusion
10. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. See attached PTO-892.
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER EGLOFF whose telephone number is (571)270-3548. The examiner can normally be reached on Monday - Friday 9:00 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai can be reached at (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) 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.
/Peter R Egloff/
Primary Examiner, Art Unit 3715