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 .
DETAILED ACTION
Response to Amendment
In the amendment dated 06/08/2026, the following occurred: Claims 1, 14 and 29 have been amended. Claims 7-8, 10, 20-21, 23, 25 and 27-28 were canceled.
Claims 1-6, 9, 11-19, 22, 24, 26 and 29 are currently 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 1-6, 9, 11-19, 22, 24, 26 and 29 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.
Claims 1, 14 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a system, method and a non-transitory computer readable medium for identifying suitable patient subgroups for biologics.
Regarding claims 1, 14 and 29, the limitation of (claim 1 being representative) to determine suitability for enhanced treatment for a respiratory ailment: to collect use data to deliver controller or rescue respiration medicament to a patient; confirm use of the respiration medicament; to identify a breath biomarker to determine a response to the controller or the rescue respiration medicament provided; and storing the collected use data comprising injection data; based on the collected use data, determining whether the patient is over a first threshold level of adherence in use of based on the collected use data, determining whether the patient has a rescue respiration medicament use over a second threshold level, identifying supplemental patients in relation and control use of the respiration medicament use, and providing a notification of recommendation of the enhanced treatment if the patient is over the first threshold level and the second threshold level and an injection interface configured to graphically provide: regions on the patient to inject and/or receive the respiration medicament associated with the recommendation, regions on the patient comprising previous treatment sites, and a responsive confirmation of a treatment as crafted, is are processes that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is other than reciting a communication interface, a memory and one or more processors (in claim 1) a communication interface and a storage device (in claim 14) and a non-transitory computer readable medium, a processor, a communication interface and a storage device (in claim 29), the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, the claims encompass identifying suitable patient subgroups for biologics in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recite the additional elements of a communication interface, a memory and one or more processors. Claim 14 recites the additional elements of a communication interface and a storage device and a data analysis module. Claim 29 recites the additional element of a non-transitory computer readable medium, a processor, a communication interface, a storage device, a memory and one or more processors. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computer components for enabling access to medical information or for performing generic computer functions) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1, 14 and 29 further recite the additional element of a respiration medicament device and an injection interface. These additional element are recited at a high level of generality (i.e. a general means to output/receive/transmit data) and amount to extra solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Claims 1, 14 and 29 also recite the additional element of a smart syringe. This additional element is recited at a high level of generality (i.e. a general means to output/collect/provide data) and amounts to extra solution activity. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Claims 1, 14 and 29 also recite the additional element of a plurality of sensors. This additional element merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element 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 integration of the abstract idea into a practical application, the additional elements of the non-transitory computer readable medium, the processor, the communication interface, the storage device, the memory and processor to perform the noted steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of a respiration medicament device and an injection interface were considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional activity in the field. MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine and conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). Therefore when considering the additional elements alone, and in combination, there is no inventive concept in the claim, and thus the claim is not patent eligible.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional element of a smart syringe configured to confirm use of the respiration medicament, collect use data and provide controller or rescue respiration medicament was considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional in the field of healthcare (Hwang at (US 2012/0265591) at [0135], [0187] and [0188], see Bruehwiler (US 2012/0041373) at [0109], and see Cheng (WO 2017051271 A1) at Fig. 4 that teach a smart syringe for providing/dispensing medication). Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional element of a plurality of sensors was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 2-6, 9, 11-13, 15-19, 22, 24 and 26 are similarly rejected because they either further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Dependent claim 2 further defines the respiratory ailment. Dependent claim 3 further defines the enhanced treatment. Dependent claim 4 defines the first threshold level. Dependent claim 5 further defines the second threshold level. Dependent claim 6 defines a mobile computing device. Claim 6 further recites the additional element of a mobile computing device which is analyzed as above and does not provide practical application or significantly more. Dependent claim 9 further defines an enhanced treatment module engine. Claim 9 further recites the additional element of an enhanced treatment module engine which is analyzed as above and does not provide practical application or significantly more. Dependent claim 11 further defines the enhanced treatment. Dependent claim 12 further defines the interface. Claims 11, 12 and 24 further recite the additional element of an interface which is analyzed as above and does not provide practical application or significantly more. Dependent claim 13 further defines a health monitor. Dependent claim 15 further defines the respiratory ailment. Dependent claim 16 further defines the enhanced treatment. Dependent claim 17 further defines the first threshold level. Dependent claim 18 further defines the second threshold level. Dependent claim 19 further defines establishing communication. Dependent claim 22 further defines tracking a use. Dependent claim 24 further defines the enhanced treatment. Dependent claim 26 further defines monitoring the patient. Like claims 1, 14 and 28, claims 2-6, 9, 11-13, 15-19, 22, 24 and 26 further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-6, 9, 11-19, 22, 24, 26 and 29, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Assuming arguendo, the claims contain an abstract idea (which Applicant does not concede), under Prong Two of the Revised Step 2A procedure requires the additional claim elements integrate the alleged abstract idea into a practical application, which renders the claims- as a whole-patent eligible. Through the claim amendments, Applicant asserts the abstract idea is integrated into a practical application. In particular, "The system 100 may also analyze/identify subgroups of patients who are the most responsive to different biologics. Responses to biologics could be based on inhaler use, and/or associated with other sensor data, e.g. respiratory rate, heart rate, bronchoconstriction, or biomarker in breath. Thus, data may be collected through a sensor that may include sensor reported rescue inhaler usage, sensor reported nighttime waking, and sensor-derived respiratory control. Night time awakenings and night time use of the rescue inhaler may be a proxy for waking up at night to relieve symptoms. Having nighttime awakenings is associated with poor outcomes in asthma. Through rescue use patterns (day and night) and the Asthma Control Test, asthma control specifically may be determined.." See paragraph [0078]. The claims have been amended to disclose a practical application, integrating technology with a limitation defined by the discrete identification of a biomarker through breadth. The identification of a biomarker generates a response to the controller of the medicant device. The controller determines a response based on the biomarker data received from the sensors, resulting rescue medicament analysis for subsequent action. Therefore, Applicants respectfully request that the Examiner withdraw the rejection of Claims 1-6, 9, 11-19, 22, 24, 26 and 29 under 35 U.S.C. § 101.
Regarding 1, The Examiner respectfully disagrees that the claims integrate the abstract idea into a practical application. Analyzing/identifying subgroups of patient who are the most responsive to different biologics is an abstract idee. The use of sensor to collect data is analyzed as an additional element and merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application. Furthermore, the claims use generic sensor and the technology of such sensors is not being improved upon.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. 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.
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Barrett (US 2019/0102522) teaches pre-emptive asthma risk notification based on medicament device monitoring. Hwang (US 2012/0265591) discloses cost-effective apportionment technologies suitable for facilitating therapies. Bruehwiler (US 2012/0041373) discloses needle changing apparatus. Cheng (WO 2017051271 A1) discloses smart syringe: monitoring medical intervention information. Nemoto (US 20100217121) discloses liquid injector, fluoroscopic imaging system, and a computer program.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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/L.T.K./Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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