Prosecution Insights
Last updated: April 19, 2026
Application No. 18/019,408

INHALER SYSTEM

Non-Final OA §101§103§112
Filed
Feb 02, 2023
Examiner
PHILIPS, BRADLEY H
Art Unit
3799
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Norton (Waterford) Limited
OA Round
1 (Non-Final)
67%
Grant Probability
Favorable
1-2
OA Rounds
3y 12m
To Grant
97%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allow Rate
319 granted / 477 resolved
-3.1% vs TC avg
Strong +30% interview lift
Without
With
+29.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 12m
Avg Prosecution
31 currently pending
Career history
508
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
44.3%
+4.3% vs TC avg
§102
23.0%
-17.0% vs TC avg
§112
22.6%
-17.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 477 resolved cases

Office Action

§101 §103 §112
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 . Priority Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(a-d) with reference to Application Number: GB2012249.5 filed on 08/06/2020. Information Disclosure Statement The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609. Drawings The drawings are objected to because the unlabeled rectangular box(es) shown in the drawings should be provided with descriptive text labels. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. 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 1-18 and 20 - 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. With respect to step 1, claims 1-18 and 20 – 21are all within at least one of the four categories of invention. More specifically, claims 1- 12 and 20 – 21 are directed to a machine, and claims 13-18 are directed to a process. In accordance with MPEP 2106.04, each of claims 1-18 and 20 - 21 has been analyzed to determine whether it is directed to any judicial exceptions. Step 2A, Prong 1 per MPEP 2106.04(a) Each of claims 1-18 recites at least one step or instruction for determining a deviation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III). The claimed limitations involve concepts performed in the human mind, namely observation, evaluation, and judgement, which are mental processes in MPEP 2106.04(a)(2)(III). Accordingly, each of claims 1-18 recites an abstract idea. Independent claims 1, 13, and 20 recite: “determine said level of acute risk based on the at least one value and the second value” (evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)); Further, dependent claims 2-8, 10-16, and 18 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed. Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a). Step 2A, Prong 2 per MPEP 2106.04(d) The above-identified abstract idea in each of independent claims 1, 13, 20 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h). Further, the additional elements of: “an inhaler configured to deliver a medicament to the subject for treating the respiratory disease, the inhaler comprising a use determination system configured to determine at least one first value of a usage parameter relating to use of the inhaler”, as well as: “a processor configured to: receive the at least one first value; and, receive a second value indicative of whether the subject is also suffering from a viral respiratory infection” as recited in claims 1, and claims 1 and 13, respectively, are generically recited elements which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent claims 1, 13, and 20 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d). Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., the processing unit as recited in claims 1 and 9). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. V. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claims 1, 13, and 20 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I). Accordingly, independent claims 1, 13, and 20 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d). Step 2B per MPEP 2106.05 None of claims 1-18 and 20 - 21 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons. These claims require the additional elements of: “an inhaler configured to deliver a medicament to the subject for treating the respiratory disease, the inhaler comprising a use determination system configured to determine at least one first value of a usage parameter relating to use of the inhaler”, as well as: “a processor configured to: receive the at least one first value; and, receive a second value indicative of whether the subject is also suffering from a viral respiratory infection” as recited in claims 1, and claims 1 and 13, respectively, and their respective dependent claims. The above-identified additional elements are generically claimed components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The inhaler and processor provide mere data gathering in obtaining to the first and second values used to automate the mental task. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. Further, the above-identified additional element of an inhaler does no more than generally link the use of the above-identified abstract idea(s) to a particular technological environment or field of use as described in MPEP 2106.05(h). Accordingly, in light of Applicant’s specification, the claimed terms inhaler and processor are reasonably construed as generic devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f). Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the ventilator, processing unit, and output unit. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer and ventilation arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)). The recitation of the above-identified additional limitations in Claims 1-18 and 20 – 21 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. For at least the above reasons, the devices and process of Claims 1-18 and 20 - 21 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 13, and 20 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05. Therefore, for at least the above reasons, none of the Claims 1-18 and 20 – 21 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-18 and 20 -21 are not patent eligible and rejected under 35 U.S.C. 101. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “use determination system” in claims 1 – 6, 11 – 18, and 20 - 21. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 10 recites the limitation " the sensor for sensing the parameter ". There is insufficient antecedent basis for this limitation in the claim, as it is unclear which “parameter” this refers to: the usage parameter, the later recited “a parameter”, or another third parameter. Claim Rejections - 35 USC § 103 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 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. Claim(s) 1 – 4, 7 – 8, 11 – 14, 17 – 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barrett (US 20220254499) in view of Gern (“Viral respiratory infection and the link to asthma”). 1. Barrett discloses a system for determining a level of acute risk to a subject suffering from a chronic respiratory disease [0001], the system comprising: an inhaler configured to deliver a medicament to the subject for treating the respiratory disease (160, [0034]), the inhaler comprising a use determination system configured to determine at least one first value of a usage parameter relating to use of the inhaler (120, [0036 -0039]); and a processor [0062] configured to: receive the at least one first value [0090]; receive a second value indicative of whether the subject is also suffering from an environmental condition (e.g. airborne reactants like pollutants, see [0093], [0099]) and/or triggering parameter (e.g. parameters that may have played a role in triggering the rescue event or any other relevant information, see [0092]); and determine said level of acute risk based on the at least one first value and the second value (see for example [0110 – 0112], where data such as contextual parameters is compared against rescue medication usage to determine risk of future rescue events; see also [0099-100], Fig. 6 the model and risk analysis is determined by inputting the event data or medication use with other contextual data). While Barrett discloses that the additional value for determining the level of risk can include triggering conditions such as airborne reactants, parameters that may have played a role in triggering the rescue event, patient parameters, and any other relevant information, Barrett does not disclose receiving a second value indicative of whether the subject is also suffering from a viral respiratory infection. Nonetheless, respiratory infections are well known to trigger asthmatic exacerbations, and Gern discloses that a value indicative of whether the subject is also suffering from a viral respiratory infection impacts the level of acute risk of asthma exacerbation (see S79, c. 1, para. 3 diagnosis of respiratory viral infections is linked with exacerbations of asthma, with close to one-half of such episodes triggered by viral infections such as RV). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the patient relevant triggering information of Barret to incorporate diagnosis of respiratory infection as taught in Gern for the benefit of incorporating a highly important predictor of asthma exacerbations when determining acute risk of the disease and developing further models predictive of the risk. 2. The system according to claim 1, comprising a user interface, wherein the processor is configured to control the user interface to issue a notification based on said level of risk or wherein the user interface is configured to enable input of said second value (see Barrett, [0070, 0071]). 3. The system according to claim 2, wherein the user interface is at least partly defined by a first user interface of a user device; and wherein the user device is at least one selected from a personal computer, a tablet computer, and a smart phone (see Barrett, [0065]). 4. The system according to claim 3, wherein the processor is at least partly included in a first processor included in the user device (see Fig. 4, Fig. 2, [0062]). 7. The system according to claim 1, wherein the usage parameter comprises a use of the inhaler; and wherein the use determination system comprises a sensor for detecting inhalation of the respective medicament performed by the subject or a mechanical switch configured to be actuated prior to, during, or after use of the inhaler (see Barrett, [0041 – 42]). 8. The system according to claim 1, wherein the usage parameter comprises a parameter relating to airflow during inhalation of the respective medicament performed by the subject (see [0041], sensor to detect inhalation by the user). 11. The system according to claim 1, wherein the medicament comprises albuterol, budesonide, beclomethasone, fluticasone, formoterol, salmeterol, indacaterol, vilanterol, tiotropium, aclidinium, umeclidinium, glycopyrronium, salmeterol combined with fluticasone, beclomethasone combined with albuterol, or budesonide combined with formoterol [0034]. 12. The system according to claim 1, wherein the viral respiratory infection is caused by a rhinovirus, an influenza virus, a respiratory syncytial virus, an adenovirus, a metapneumovirus, or a coronavirus (Rhinovirus RV, see Gern). 13. A method for determining a level of acute risk to a subject suffering from a chronic respiratory disease, the method comprising: receiving at least one first value of a usage parameter relating to use of an inhaler from a use determination system included in an inhaler configured to deliver a medicament to the subject for treating the respiratory disease; receiving a second value indicative of whether the subject is also suffering from a viral respiratory infection; and determining said level of acute risk based on the at least one first value and the second value (see claim 1 above). 14. The method according to claim 13, further comprising controlling a user interface to issue a notification based on said level of risk or wherein the receiving the second value comprises receiving the second value inputted via a user interface (see claim 2 above). 17. The method according to claim 13, wherein the usage parameter comprises a use of the inhaler or a parameter relating to airflow during an inhalation performed by the subject during the use of the inhaler (see claims 7 and 8 above). 18. The method according to claim 13, wherein the viral respiratory infection is caused by a rhinovirus, an influenza virus, a respiratory syncytial virus, an adenovirus, a metapneumovirus, or a coronavirus (see claim 12 above). 20. A computer-readable storage medium comprising computer-executable instructions that, when executed by a processor, cause the processor to: receive at least one first value of a usage parameter relating to use of an inhaler from a use determination system included in an inhaler configured to deliver a medicament to the subject for treating the respiratory disease; receive a second value indicative of whether the subject is also suffering from a viral respiratory infection; and determine said level of acute risk based on the at least one first value and the second value (see claim 1 above). Claim(s) 5 – 6, 15 – 16, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barrett (US 20220254499) in view of Gern (“Viral respiratory infection and the link to asthma”) in view of Nicholson (“Respiratory viruses and exacerbations of asthma in adults”). 5. Barret in view of Gern discloses the system according to claim 1, but does not explicitly disclose wherein the second value is a value obtained from a virus detection method for detecting the virus of the respiratory viral infection in a sample from the subject; and wherein the second value is a positive or a negative result from the virus detection method. Nicholson discloses wherein the second value is a value obtained from a virus detection method for detecting the virus of the respiratory viral infection in a sample from the subject; and wherein the second value is a positive or a negative result from the virus detection method (see p. 983, section “results” through p. 984, “effective of infections on asthma symptoms”). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to filed to modify the patient relevant triggering information of Barret to incorporate the positive or negative result from the virus detection method of Gern for the benefit of incorporating a highly important predictor of asthma exacerbations when determining acute risk of the disease and developing further models predictive of the risk. 6. The system according to claim 5, wherein said virus detection method is at least one of an assay configured for selective binding of the virus, or a nucleic acid detection method for detecting at least part of the viral genome of the virus (Nicholson, p. 983, c. 2, para. 2). 15. The method according to claim 13, wherein the second value is a value obtained from a virus detection method for detecting the virus of the respiratory viral infection in a sample from the subject; and wherein the second value is a positive or a negative result from the virus detection method (see claim 5 above). 16. The method according to claim 15, wherein said virus detection method is at least one of an assay configured for selective binding of the virus, or a nucleic acid detection method for detecting at least part of the viral genome of the virus (see claim 6 above). 21. The computer-readable storage medium according to claim 20, wherein, when executed by the processor, cause the processor to: control a user interface to issue a notification based on said level of risk or wherein the receiving the second value comprises receiving the second value inputted via a user interface; wherein the second value is a value obtained from a virus detection method for detecting the virus of the respiratory viral infection in a sample from the subject; and wherein the second value is a positive or a negative result from the virus detection method (see claims 2 and 5 above). Claim(s) 8 – 10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barrett (US 20220254499) in view of Gern (“Viral respiratory infection and the link to asthma”) in view of Mishelevich (US 5363842) 8. Barrett in view of Gern discloses the system according to claim 1, but does not disclose wherein the usage parameter comprises a parameter relating to airflow during inhalation of the respective medicament performed by the subject. Mishelevich discloses wherein the usage parameter comprises a parameter relating to airflow during inhalation of the respective medicament performed by the subject (see abstract). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify Barrett according to Mishelevich for the benefit of determining appropriate success of medicine delivery, c. 4: 15 – 25. 9. The system according to claim 8, wherein the use determination system comprises a sensor for sensing the parameter; and wherein the parameter is at least one of a peak inhalation flow, an inhalation volume, a time to peak inhalation flow, or an inhalation duration (Mischelevich, c. 4: 35 – 40). 10. The system according to claim 9, wherein the sensor for sensing the parameter is the same as or different from the sensor for detecting inhalation of the respective medicament performed by the subject (Mischelevich, c. 4: 35 – 40). 17. The method according to claim 13, wherein the usage parameter comprises a use of the inhaler or a parameter relating to airflow during an inhalation performed by the subject during the use of the inhaler (see claims 8 and 9 above). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20140129249 – discloses assessment of asthma risk including viral infection data US 20200297955 – determining asthma risk based on usage and environmental data US 20160089089 – determining asthma risk based on usage and environmental data US 6693546 – determining asthma risk based on usage and environmental data US 20190313919 – monitoring asthma symptoms Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F. 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, Brian Casler can be reached at (571) 272-4956. 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 (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. /BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
Read full office action

Prosecution Timeline

Feb 02, 2023
Application Filed
Dec 02, 2025
Non-Final Rejection — §101, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
67%
Grant Probability
97%
With Interview (+29.9%)
3y 12m
Median Time to Grant
Low
PTA Risk
Based on 477 resolved cases by this examiner. Grant probability derived from career allow rate.

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