Prosecution Insights
Last updated: April 19, 2026
Application No. 18/558,126

INHALER SYSTEM

Non-Final OA §101§102§103§112
Filed
Oct 30, 2023
Examiner
JANG, JAEICK
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Norton (Waterford) Limited
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
53 granted / 83 resolved
-6.1% vs TC avg
Strong +54% interview lift
Without
With
+53.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
25 currently pending
Career history
108
Total Applications
across all art units

Statute-Specific Performance

§101
5.7%
-34.3% vs TC avg
§103
40.9%
+0.9% vs TC avg
§102
19.1%
-20.9% vs TC avg
§112
26.2%
-13.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 83 resolved cases

Office Action

§101 §102 §103 §112
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. Status of Claims The present office action is in response to the Remarks and Amendment filed 10 / 30 /2023. As directed by the amendment, claims 2, 4, 6, 8-9, 13, 16, 18, 21-22, 27-28, 30, 35-36, and 38 have been amended, and claims 1 , 3, 5, 10-12, 14 -15 , 17, 19-20, 23-25, 29, 31-32, 37, and 39-44 have been cancelled. Thus, claims 2, 4, 6-9, 13, 16, 18, 21-22, 26-28, 30 , 33 -36, and 38 are presenting pending in this application. I ncorrect claim identifier s were used for claim 7 which should be “( Original )”, and for claim s 39-44 which should be “( Canceled )”. For compact prosecution, the examiner has examined claim 7 as previously presented and claim 39-44 as canceled . Claims 1 and 31 have been canceled by Applicant in the amendment filed 10/30/2023. Claims 2, 4, 6-9, 13, 16, 18, 21-22, 26-28 are depended upon canceled claim 1 while claim 38 is depended upon canceled claim 31. Because these claims depend from canceled base claims, they are currently deemed unsearchable and indefinite under 35 U.S.C. §112(b) as discussed below. Accordingly, these claims have not been reviewed on the merits at this time. Once these issues are addressed, the examiner reserves the right to apply prior art as is necessary . Specification The disclosure is objected to because of the following informalities: Amended Specification filed 11/17/2023, under “Cross-Reference” recites “ This application is the 371 National Stage of International Application No. PCT/EP2022/06 1579, filed April 29, 2022, which claims priority to Great Britain Application No. 2106254.2, filed April 30, 2021, the disclosures of which are incorporated herein by reference in their entireties. ” Examiner suggest replacing this paragraph with -- This application is the 371 National Stage of International Application No. PCT/EP2022/06 1579, filed April 29, 2022, which claims priority to Great Britain Application No. 2106254.2, filed April 30, 2021 .-- Examiner notes that the filing date of the PCT is the filing date for the national stage application. Therefore, any amendment that comes in with or after the filing of the national stage application in the US is not part of the original disclosure. Per MPEP 608.01(p)(I)(B) states that to be effective an incorporation by reference statement must be filing at time of filing and cannot be added after an application’s filing date. Since a 371 application’s filing date is the date the PCT was filed, an amendment in the 371 application to add an incorporation by reference is not effective and improper as new matter. Appropriate correction is required. 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 appl icant regards as his invention. Claim s 2, 4, 6-9, 13, 16, 18, 21-22, 26-28, and 38 are 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. Regarding claims 2, 4, 6-9, 13, 16, 18, 21-22, and 26-28 , they are depended to canceled claim 1. It is unclear whether they are intended to claims 30, 33, or 34. Thus, claims are currently deemed unsearchable and indefinite. See MPEP 608.01(n)(V). Regarding claim 38 , it is depended to canceled claim 31. It is unclear whether they are intended to claims 30, 33, or 34. Thus, claim is currently deemed unsearchable and indefinite. See MPEP 608.01(n)(V). 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. Claim 33-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. [STEP 1] Claims 33-34 are directed to a process/method and are one of the four statutory categories . [STEP 2A, Prong One] The claim s are directed to an Abstract Ide a, specifically collecting and analyzing information and a mental process. The claims recite t he steps of receiving values and controlling the user interface to merely display or “permit comparison between” the values ” (observation which grouped as a mental process under the 2019 PEG). The above limitation are directed to mental process that can be done by a person simply observing received information and merely displaying associated data for comparison in the human mind or with pen and paper. [STEP 2A, Prong Two] The claim s do not recite additional elements that integrate the judicial exception into a practical application. While the claim recites a “ user interface ”, this element does not integrate the judicial exception into practical application. The user interface is merely used as to display the received values in order to compared the received values. The generic output in means to display limitation is recited in a high level of generality, i.e., as a generic display performing the action of outputting the information. Thus, such additional limitation do not integrate the abstract idea into practical application because they do not impose any meaningful limitations on practicing the abstract ideas. The “user interface” merely serves as a generic environment in which the abstract idea is executed. In other words, there is nothing more than an attempt to generally link the use of judicial exception to the technological environment. [STEP 2B] The claim s do not cite any additional structures that would make it significantly more than the judicial exception because they do not amount to more than simply collecting and displaying information which is simply an attempt to limit the user of the abstract idea to a particular technological environment. See MPEP 2106.05(h). The additional elements did not add significantly more to the abstract idea because they were simply applying the abstract idea on a user interface without any recitation of details of how to carry out the abstract idea. The rationale set forth for the 2nd prong of the eligibility test above is also applicable to the entirety of the claims. Likewise, the rationale set forth for the 2nd prong of the eligibility test above for claim s 33-34 are also applicable to c laim s 35-36 . Claim Rejections - 35 USC § 102 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 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 33 and 35 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Shetty et al. (US 20170270260 A1). Regarding claim 3 3 , Shetty et al. discloses, a method comprising: receiving a baseline value of an inhalation parameter indicative of a baseline lung function of a subject (¶0020, “the method additionally includes comparing the data to baseline values and/or a patient's historical data to identify trends and/or data of potential concern ”; ¶0142-0143, “ spirometry measures are calculated and the data is compared to stored baseline data or threshold values … recorded measurements deviate from the healthy baseline values by more than a certain percent ”; criteria as shown in Fig 11C) ; receiving a post-exacerbation value of the inhalation parameter determined from one or more post-exacerbation inhalations performed by the subject using at least one inhaler (¶0069, “ a portable, handheld device for monitoring lung function and respiratory conditions … in order to improve the personalization of treatment and the predictability of respiratory symptom attack ”; ¶0139, “ a patient uses the measurement device 100 multiple times a day. For example, in one embodiment, the patient takes preventative, maintenance asthma medicine twice daily. Preferably, before or after inhaling the asthma medicine from the device 100 , the patient exhales forcefully into the device 100 , generating pressure readings, and optionally, cardiopulmonary biomarker readings, for the system 20 ”; ¶0142, “ following every forced expiration, spirometry measures are calculated and the data is compared to stored baseline data or threshold values ” ; Examiner interprets the “post-exacerbation value” as any inhalation parameter that has been measured after the attack or the exacerbation) controlling a user interface to communicate the baseline value (the threshold/baseline indicated as “well” from user interfaces of Figs 11A and 11C) ; and controlling the user interface to communicate the post-exacerbation value such as to permit comparison between the post-exacerbation value and the baseline value (¶0142-0143, “…can i nteract with the current data and stored data … if the recorded measurements deviate from the healthy baseline values by more than a certain percent ... configured to send data signals to the output display such that a warning appears on the GUI on the screen of the patient's remote computing device ”; user interfaces of Figs 11A-C). Regarding claim 35 , Shetty et al. discloses the method of claim 33 as discussed above. Shetty et al. further disclose, herein said baseline value is determined from one or more inhalations using the at least one inhaler when the subject is not experiencing an exacerbation (¶0162, “… utilizes the lung function and capacity measurements generated from a portable lung function measurement device to deliver objective measurements and personalized recommendation … The stored baseline data may be pre-programmed and based on a population average, for example, an average value for individuals within a certain age bracket and fitness level, or it may be based on a user-specific baseline calculated from previous recordings for the user ”) . Claims 34 and 36 are rejected under 35 U.S.C. 102 (a)( 2 ) as being anticipated by Barrett et al. (US 20200058403 A1). Regarding claim 34 , Barrett et al. discloses, a method comprising : receiving a baseline rescue inhaler usage (¶0053, “…risk analysis m ay be performed on rescue and controller medication use … rescue use trends over time, and rescue use comparisons to other relevant populations ”; ¶0110, “… a baseline threshold based on the total number of usage events over a specified prior time period … an average of the number of rescue usage events per day ”) ; receiving a post-exacerbation rescue inhaler usage (¶0111, “ describing a day during which the number of recorded rescue usage events exceeded the baseline threshold. The identified days exceeding the baseline threshold may collectively be referred to as exacerbation days ”; ¶0116-0117, “d epending on data such as the count of exacerbation days, the count of days including a rescue usage event, as well as primary patient data vs. secondary patient data … the value of the relative risk score, the number of rescue usage events in the presence or absence of the a trig ger… a trigger by the data analysis module 131 , the notification module 580 generates a risk score notification ”; Examiner interprets the “ post-exacerbation rescue inhaler usage ” as to any usage except during the attack/exacerbation) ; controlling a user interface (a dashboard of Figs 3A- 3 B) to communicate the baseline rescue inhaler usage (¶0071- 00 7 6 , implies the dashboard displays various information such as the contents of notification, risk parameters, and data involving rescue events, statistics, maps including patient data and community data and historical medication recue event, and event trend which display recue device usage for the time period; ) ; and controlling the user interface to communicate the post-exacerbation rescue inhaler usage such as to permit comparison between the post-exacerbation rescue inhaler usage and the baseline rescue inhaler usage (¶0071-0076; ¶0110-0111,0116-0119, implies that the risk score notification is generated based on the comparison among data including rescue usage with and without exacerbation and display via the dashboard of Figs 3A-3B). Regarding claim 36 , Barrett et al. discloses, the method of claim 34 as discussed above. Barrett et al. further discloses, wherein said baseline rescue inhaler usage is determined when the subject is not experiencing an exacerbation (¶0053,0110-0111, implies that the rescue usage includes not experiencing an exacerbation/absence of the trigger) . 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. 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 . Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Shetty et al. (US 20170270260 A1) in view Darket (US 20160007913 A1) . Regarding claim 30 , Shetty et al. discloses, a method of post-exacerbation treatment of a respiratory disease in a subject (¶0002-0006, “…w ith appropriate treatment, a person typically recovers completely from an acute attack … reducing the frequency and/or severity of asthma attacks ”; ¶0012, “ a handheld device for monitoring and treating respiratory conditions such as, for example, COPD or asthma ”; ¶0070, “ a user may be able to take actionable steps to avoid or minimize the severity of a future or current attack of symptoms ”) , the method comprising: an inhalation parameter criterion (a graph showing condition of FEF, Fig 11C; ¶0070, “ display lung function monitoring information in a manner that is meaningful to a lay user, such information being based, at least in part, on the data acquired from the device. With such information, a user may be able to take actionable steps to avoid or minimize the severity of a future or current attack of symptoms ”) by one or more post-exacerbation inhalations performed by the subject with at least one inhaler (¶0008-0009, “ handheld measurement device for monitoring lung function… calculate meaningful lung function measurements from pressure or airflow signals. The calculated lung function measurements may include breathing rate, Peak Expiratory Flow rate (PEFR), Forced Expiratory Flow (FEF) rate within specific intervals or fractions, for example FEF25-75%, Forced Expiratory Volume within a given time interval such as the first second (FEV1), Forced Vital Capacity (FVC), tidal volume, or other lung function measurements ”). While Shetty et al. discloses, the need of a more aggressive therapy such as an orally-administered corticosteroid after use of fast-acting inhaler as over-reliance on the fast-acting inhaler may increase the risk of asthma-related death, and the means to t rack the severity levels of a patient's acute respiratory attacks and determine if medication was administered at appropriate times and in appropriate doses by storing and accumulating data about medication usage and lung function over time (¶0138) , Shetty et al. does not specifically discloses, treating the subject with an initial dose of an oral corticosteroid until fulfilment of an inhalation parameter criterion by one or more post-exacerbation inhalations performed by the subject with at least one inhaler However, Darket which is analogous art to the claim invention for measuring the lung function and the inhalation technique of a human subject in particular asthma (abstract) discloses, treating the subject with an initial dose of an oral corticosteroid (¶0013, “ In a severe asthma exacerbation, oral glucocorticoids are added to these treatments … in the case of severe persistent disease, in which oral steroids may be needed ”) until fulfilment of an inhalation parameter criterion by one or more post-exacerbation inhalations performed by the subject with at least one inhaler (¶0085, “ comparing the actual measurement with standard data for the patient (lung function data representative of the state where the patient is optimally treated and essentially free of disease symptoms), thereby providing a measure of the relative lung function. The relative lung function is directly related to the state of disease in the patient, and the system will thereby be able to provide the patient with valuable insight as to his/her condition at any time ”) a nd responsible to said fulfilment, changing the dose of the oral corticosteroid is changed from the initial dose ( ¶0090, “t he measurement of the relative lung function would be to suggest the patient to take a particular medicament in response to one relative lung function, and another particular medicament in response to another relative lung function ”) in order to increase the efficacy of the medicinal products by reducing/increasing and/or optimizing the intake of medicine (¶0139). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Shetty et al. to include a step of treating the subject with an initial dose of an oral corticosteroid until fulfilment of an inhalation parameter criterion by one or more post-exacerbation inhalations performed by the subject with at least one inhaler as taught by Darket in order to increase the efficacy of the medicinal products by reducing/increasing and/or optimizing the intake of medicine (¶0139). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Weinstein et al. (US Pat 5830490 ) is cited for the device with the use of aerosol and oral medications for the treatment of disorders i ncluding respiratory tract disorders for the purpose of reducing medication error and increasing therapeutic compliance. Shames (US 20050089517 A1) is cited for a post-exacerbation treatment involving oral corticosteroids which is a prednisone burst of up to 60 mg per day for up to 14 days (¶0145). Manice et al. (US 20190385727 A1) is cited for the communication to a potential exacerbation, potential complication, and/or potential acute even t (¶0111) by t racking these lung function measurements over time (¶0110). Levy et al. (US 20100094099 A1) is cited for a method of monitoring inhaled drug usage to predict when an acute attack or exacerbation of a disease (abstract) Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JAEICK JANG whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-4569 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:30 - 4:30 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kendra D Carter can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-9034 . 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. /J.J./ Examiner, Art Unit 3785 /JOSEPH D. BOECKER/ Primary Examiner, Art Unit 3785
Read full office action

Prosecution Timeline

Oct 30, 2023
Application Filed
Mar 26, 2026
Non-Final Rejection — §101, §102, §103 (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
64%
Grant Probability
99%
With Interview (+53.9%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 83 resolved cases by this examiner. Grant probability derived from career allow rate.

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