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
The present Office Action is in response to the Request for Continued Examination dated 11/12/2025.
In the amendment dated 11/12/2025, 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.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered.
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; 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.
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.
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. All dependent claims 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… As cited in the MPEP, Classen Immunotherapies Inc. v. Biogen IDEC provides another example of claims that recited meaningful limitations. 659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011). the claims recited methods that gathered and analyzed the effects of particular immunization schedules on the later development of chronic immune- mediated disorders to identify a lower risk immunization schedule, and then immunized mammalian subjects in accordance with the identified lower risk schedule (thereby lowering the risk that the immunized subject would later develop chronic immune-mediated diseases). Similar to Classen, the current invention receives medical data, wherein the data is analyzed to determine a diagnosis… In particular, Applicant claims "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." Referring back to Classen, although the analysis step was an abstract mental process that collected and compared known information, the immunization step was meaningful because it integrated the results of the analysis into a specific and tangible method that resulted in the method "moving from abstract scientific principle to specific application." 659 F.3d at 1066-68. Similar to Classen, the disclosure provides a practical application wherein a treatment is provided. For example, another source of data may include a data connection to a smart-syringe. Such smart syringes are known in the art, and could be connected to the current system to confirm use of the biologic, time and date of use, quantity of drug, batch of drug, etc. per paragraph [0079]. Accordingly Applicant asserts there is patentable subject matter and requests the rejection to be removed.
Regarding 1, The Examiner would like to clarify that the claims were analyzed to 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, not a mental process grouping of abstract ideas.
Moreover, the Examiner respectfully disagrees that the claims integrate the abstract idea into a practical application. Receiving medical data and analyzing the medical data to determine a diagnosis is an abstract idee. The injection interface is analyzed as an additional element and does not provide a practical application as it graphically provides information (i.e., display data). Displaying data is an abstract idea and the injection interface is recited at a high level of generality and amount to extra solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Moreover, using a smart syringe to provide data to confirm the use of a medicament, time and quantity of the medicament is also an abstract idea. The smart syringe is analyzed as an additional element and does not provide a practical application because it is recited at high level generality and amounts to extra solution activity.
Rejection under 35 U.S.C. § 103
Regarding the rejection of claims 1-6, 9, 11-19, 22, 24, 26 and 29, the Examiner has considered the Applicant’s arguments, and finds them persuasive. The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within the independent claim. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: a communication interface to collect use data of a respiration medicament device to deliver controller or rescue respiration medicament to a patient; a smart syringe in communication with the communication interface and configured to confirm use of the respiration medicament; a memory comprising instructions stored thereon, which when executed by one or more processors, causes the one or more processors to perform: storing the collected use data comprising injection data, based on the collected use data from the smart syringe, determining whether the patient is over a first threshold level of adherence in use of the respiration medicament device 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 from the smart syringe. And wherein the controller or rescue respiration medicament is provided to the patient by a smart syringe.
Conclusion
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.
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, Robert Morgan can be reached on 571-272-6773. 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 the 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/docs for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LIZA TONY KANAAN/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683