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 .
Response to Amendment
The present office action is in response to the Arguments/Remarks filed 06/30/2026. As directed by the amendment, Claims 2, 4, 6-7, 18, 21, 28, 30, and 38 have been amended. Thus, claims 2, 4, 6-9, 13, 16, 18, 21-22, 26-28, 30, 33-36, and 38 are presenting pending in this application.
Applicant has amended specification under section “Cross-Reference” to address minor informalities in the drawing. Therefore, the previously held specification objections are hereby withdrawn.
Applicant has amended claims 2, 4, 6-9, 13, 16, 18, 21-22, 26-28 and 38 to overcome the rejections under 35 U.S.C. §112. Therefore, the previously held claim rejections are hereby withdrawn.
Response to Arguments
Applicant’s arguments, see sections under “Rejection of Claim 30 under 35 U.S.C. §103” of Page 8, and “Rejection of Claim 33 under 35 U.S.C. §102” of Page 11, filed 06/30/2026, have been fully considered and are persuasive. The prior art, Shetty et al., discloses detecting an inhalation and an exhalation (¶0019), but the prior art relies upon the exhalation parameters to monitor the lung function in order to avoid or minimize the severity of a future or current attack (¶0070). Therefore, previously held rejections have been withdrawn.
Looking at other consideration, the limitation of claim 33 recites, the limitation of “a rescue inhaler usage criterion” encompasses any predetermined condition based on the subject’s use of the rescue inhaler in BRI. The claim does not specify the manner in which usage is determined or the nature of criterion. Further, the claim does not specify what or who evaluate the inhalation parameter criterion or the rescue inhaler usage criterion as the claim does not require any particular structure to do the evaluation and thus that they can be all mentally done. Thus, if the patient feels that the inhalation parameter criterion is achieved by providing an inhalation effort to use the inhaler, it would read onto the limitation in broadest reasonable interpretation. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
However, upon further consideration, a new ground(s) of rejection is made as set forth herein.
Applicant’s arguments, see sections under ““Rejection of Claim 34 under 35 U.S.C. §102” of Page 12, filed 06/30/2026, have been fully considered and are not persuasive.
Applicant argues that the “post-exacerbation rescue inhaler usage” is limited to a rescue inhaler usage after an exacerbation has occurred. Barrett et al. describes identifying days on which rescue usage events exceed a baseline threshold and referring to those days as “exacerbation days” and providing risk analysis and risk notification based on information such as a count of exacerbation days, a count of days including a rescue usage event and the number of rescue usage events in the presence or absence of a trigger. Theses passages do not disclose receiving rescue inhaler usage after an exacerbation.
In regards to the interpretation, Examiner agrees with Applicant and interpreted as a usage after the exacerbation. Looking into another consideration, the interpretation is not limited to an immediate usage/a single usage of the inhaler when the exacerbation/attack occurs. It can be interpreted to any usage(s) over time after the exacerbation/attack occurred.
However, Examiner respectfully disagree with Applicant’s argument. As noted by Applicant, Barrett et al. identifies the “exacerbation days” when the rescue usage event exceeds a baseline threshold of the usage, but it continues to track the number of rescue usage events over time in order to continuously identify and count “exacerbation” days over time and provide a risk score notification based on collected data (¶0116-0117) which read into the limitation of the “post-exacerbation rescue inhaler usage”. As discussed in the preceding Office action, the user interface of Barrett et al. provides the baseline rescue inhaler usage and the post-exacerbation rescue inhaler usage based on the comparison of collected data to generate the risk score notification.
For these reasons, the previously held rejection will be maintained as established in the preceding Office action dated 03/31/2026.
Applicant’s arguments, see sections under “Rejection of Claim 33 under 35 U.S.C. §101” of Page 11, and Rejection of Claim 34 under 35 U.S.C. § 101 of Page 11, filed 06/30/2026, have been fully considered and are not persuasive.
Applicant argues that said claims related to a practical application in the technical field of respiratory-disease management.
Examiner respectfully disagree with Applicant’s arguments. Although the claims are directed to the field of respiratory disease management, merely limiting the abstract idea to a particular technical environment does not integrate the judicial exception into a practical application. See MPEP § 2106.05 (h). As discussed in preceding Office action, the limitations of the claims amounts to collecting, displaying and comparing information, which are abstract ideas, implemented in the context of respiratory disease management. Claims do not further positively require use or operation of the inhaler, beyond somehow receiving information of the inhaler’s usage. Nor do the claims require controlling the inhaler, modifying its operation, or improving its functionality. Such generic data gathering and presentation are insufficient to integrate the recited abstract idea into a practical application. See MPEP § 2106.05(a), 2106.05(g), and 2106.05(h).
For these reasons, the previously held rejection will be maintained as established in the preceding Office action dated 03/31/2026.
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 18 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 18 recites the limitation “the pharmaceutical composition" in ln 1. There is insufficient antecedent basis for this limitation in the claim.
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 claims are directed to an Abstract Idea, specifically collecting and analyzing information and a mental process. The claims recite the 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 claims 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 claims 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 claims 33-34 are also applicable to claims 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 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 may 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, “depending 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 trigger… 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-3B) to communicate the baseline rescue inhaler usage (¶0071-0076, 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.
Claims 2, 4, 6-9, 13, 16, 18, 21-22, 26-28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Blissenbach et al. (EP 0813155 A1) in view of NIH (Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma- Full Report, Published Sep 2012, https://www.nhlbi.nih.gov/sites/default/files/media/docs/EPR-3_Asthma_Full_Report_2007.pdf).
Regarding claim 30, Blissenbach et al. discloses, a method of post-exacerbation treatment of a respiratory disease in a subject (Col 3, ln 29-37, implies a method of administering appropriate therapies such as identifying preferred treatment regimens for given states of disease including before and after the exacerbation), the method comprising;
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 an inhaler (Col 9, ln 17- Col 10, ln 15, “… Classifier I individuals are active members who have used ≥ 8 puffs/day of beta-agonist therapy with ≥ 4 puffs/day of inhaled anti-inflammatory medications, and utilized oral corticosteroids during the previous three months… an inhaled anti-inflammatory medication (Intal, Tilade, Beclovent, Vanceril, Decadron Respihaler, Azmacort, Aerobid or Aerobid-M)….)”; Examiner notes that claim does not specify what or who evaluate the inhalation parameter criterion or the rescue inhaler usage criterion as claim does not require any particular structure to do the evaluation and thus that they can be all mentally done. Thus, the “inhalation parameter criterion” is understood as merely an inhalation effort in means to use the inhaler as BRI as discussed above) or fulfilment of an inhaler usage criterion relating to post-exacerbation usage of the inhaler configured to deliver a medicament to the subject, (Col 9, ln 17- Col 10, ln 15, “beta-agonist metered dose inhaler use of albuterol (Ventolin, Proventil), metaproterenol (Alupent, Metaprel), bitolterol (Tornalate), isoetharine (Bronkometer), isoproterenol (Medihaler-Iso, Mistometer), isoproterenol/phenylephrine (Duo-Medihaler), salmeterol…The severity of illness (Classifier 1 - 6) in high dose beta-agonist users is then stratified based on the utilization of an inhaled anti-inflammatory medication (Intal, Tilade, Beclovent, Vanceril, Decadron Respihaler, Azmacort, Aerobid or Aerobid-M) and oral corticosteroids (cortisone, hydrocortisone, prednisone, triamcinolone, prednisolone, methylprednisolone, or dexamethasone) during the same time period. The use of oral corticosteroids implies an increased severity in their condition… Classifier I individuals are active members who have used ≥ 8 puffs/day of beta-agonist therapy with ≥ 4 puffs/day of inhaled anti-inflammatory medications, and utilized oral corticosteroids during the previous three months…”).
While Blissenbach et al. discloses the variously metered dose inhaler use of beta-agonist metered dose inhaler use of albuterol (Ventolin, Proventil), metaproterenol (Alupent, Metaprel), bitolterol (Tornalate), isoetharine (Bronkometer), isoproterenol (Medihaler-Iso, Mistometer), isoproterenol/phenylephrine (Duo-Medihaler), salmeterol (Serevent), terbutaline (Brethaire), or pirbuterol (Maxair) and utilization of an inhaled anti-inflammatory medication and oral corticosteroid (Col 9, ln 17- Col 10, ln 15) and the treatment adjusted based on the evaluation of each patient in accordance with a medical practice, and suggests alternative therapy (Col 10, ln 17-Col 11, ln 6, implies the dosage may change based on the evaluation of each patient in accordance with a medical practice, and suggest alternative therapy which may involve standard oral therapy or no oral therapy), but the prior art does not specifically disclose the inhaler is a rescue inhaler and responsive to said fulfilment, changing the dose of the oral corticosteroid from the initial dose.
However, NIH which is analogous art to the claimed invention for the Diagnosis and Management of Asthma, teaches an inhaler can be used with SABA which is a rescue inhaler and (PG 55-56, under “The Expert Panel recommends…”; PG 236-237 under “Safety of Inhaled Short-Acting Beta2-Agonists which implies albuterol is one of main SABAs in use today and effective agonists), a method of determining the severity based on the usage of the SABA (Fig 4-2a, Fig 4-2b), and a method of control and adjusting therapy involving the oral systemic corticosteroid and/or the inhaler usage (Fig 4-3a, Fig 4-3b) per usual dosages for long-term control medication (Fig 4-4a) and daily dosages for ICS and usual dosages for quick-relief medications in children (Fig 4-4b-c respectively) for children (PG 281-318, see section, “Managing asthma long term in children”) while methods and dosages are shown in Figs 4-5, 4-6, 4-7, 4-8a-c, and 4-9a-c and as described in PG 326-352 (“Managing asthma long term in Youth…and Adults”).
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 Blissenbach et al. to include a rescue inhaler and responsive to said fulfilment, changing the dose of the oral corticosteroid from the initial dose as taught by NIH as recommended guideline by the experts in the management of asthma.
Regarding claim 2, Blissenbach et al. in view of NIH discloses the method of claim 30, as discussed above.
Modified Blissenbach et al. wherein said at least one inhaler comprises at least one of: a maintenance inhaler (Blissenbach et al.: Col 3, ln 29-37; Col 9, ln 17- Col 10, ln 15) configured to deliver a maintenance medicament to the subject during the one or more post-exacerbation inhalations; or a rescue inhaler (NIH: PG 55-56, under “The Expert Panel recommends…”; PG 236-237 under “Safety of Inhaled Short-Acting Beta2-Agonists which implies albuterol is one of main SABAs in use today and effective agonists) configured to deliver a rescue medicament to the subject during the one or more post-exacerbation inhalations (NIH: PG 281-318, see section, “Managing asthma long term in children” and PG 326-352, see section, “Managing asthma long term in Youth…and Adults”).
Regarding claim 4, Blissenbach et al. in view of NIH discloses the method of claim 30, as discussed above.
Modified Blissenbach et al. further discloses, wherein the dose of the oral corticosteroid is lowered relative to the initial dose responsive to fulfilment of said rescue inhaler usage criterion (NIH: PG 281-318, 326-352, implies that the dosage can be decreased when severity is low / when the usage of SABA is low; Examiner notes that the suggested treatment plan can be from severe to mild or intermittent).
Regarding claim 6, Blissenbach et al. in view of NIH discloses the method of claim 30, as discussed above.
Modified Blissenbach et al. further discloses, wherein the subject has a baseline rescue inhaler usage (NIH: Fig 4-2a, Fig 4-2b, and Fig 4-6 which implies a baseline rescue inhaler usage in order to determine the severity of asthma), and wherein fulfilment of the rescue inhaler usage criterion is determined based on a comparison of a post-exacerbation rescue inhaler usage and the baseline rescue inhaler usage (NIH: PG 281-318, see section, “Managing asthma long term in children” and PG 326-352, see section, “Managing asthma long term in Youth…and Adults”, implies the recommendation usage based on the level of severity and the treatment plan accordingly).
Regarding claim 7, Blissenbach et al. in view of NIH discloses the method of claim 30, as discussed above.
Modified Blissenbach et al. does not specifically disclose, wherein the subject has a baseline lung function indicated by a baseline value of an inhalation parameter, and wherein fulfilment of the inhalation parameter criterion is determined based on a comparison of a post-exacerbation value of the inhalation parameter obtained from said one or more post-exacerbation inhalations to said baseline value.
However, Blissenbach et al. teaches, the trigger are determined on a disease-by-disease basis and are updated as new therapies available (Col 4, ln 19-27) and a method for managing the treatment comprising an identifying step, a categorizing step (Col 7, ln 20 - Col 8, ln 5), and an intervening step, and a method involving enhancing the individual’s or caregiver’s knowledge of the disease, triggers for acute exacerbation, and therapy involving medication and inhalation technique and providing consultation, educations or tools to monitor performance (Col 11, ln 8-26) and NIH further teaches, the importance of technique and adherences for effective therapy and the assessment of the severity of the asthma (NIH: PG 281-318, see section, “Managing asthma long term in children” and PG 326-352, see section, “Managing asthma long term in Youth…and Adults”) and steps of using the inhaler (Fig 5-7b). One of ordinary skills in the art would have recognized that evaluating whether a patient is properly using an Inhaler includes assessing one or more inhalation parameters indicative of inhalation performance, since such parameters objectively reflect whether the patient is following the prescribed inhalation technique such as merely duration of inhalation after the inhalation effort to inhale via the inhaler as a reference to follow as a baseline for proper technique.
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 Blissenbach et al. to include wherein the subject has a baseline lung function indicated by a baseline value of an inhalation parameter, and wherein fulfilment of the inhalation parameter criterion is determined based on a comparison of a post-exacerbation value of the inhalation parameter obtained from said one or more post-exacerbation inhalations to said baseline value as a predictable use of known clinical monitoring technique.
Regarding claim 8, Blissenbach et al. in view of NIH discloses the method of claim 7, as discussed above.
Modified Blissenbach et al. does not discloses, wherein the inhalation parameter criterion is fulfilled by said post-exacerbation value being within a predetermined tolerance defined for the baseline value.
However, one of the ordinary skills in the art would have recognized that the physiologic measurement exhibit normal variable even in the inhalation effort. Thus, selecting an appropriate acceptable tolerance to the technique and the adherence as discussed in claim 7 would be a result effective variable.
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 Blissenbach et al. to include wherein the inhalation parameter criterion is fulfilled by said post-exacerbation value being within a predetermined tolerance defined for the baseline value as a matter of routine optimization that depends upon the desired level of clinical sensitivity since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05(II).
Regarding claim 9, Blissenbach et al. in view of NIH discloses the method of claim 7, as discussed above.
Modified Blissenbach et al. discloses, wherein the inhalation parameter comprises an inhalation duration (as modified in claim 7).
Regarding claim 13, Blissenbach et al. in view of NIH discloses the method of claim 7, as discussed above.
Modified Blissenbach et al. does not specifically discloses, wherein the post-exacerbation value of the inhalation parameter increases towards the baseline value during reversion to said baseline lung function, and wherein the inhalation parameter criterion is fulfilled by said post-exacerbation value being at least 70% of the baseline value.
However, one of the ordinary skills in the art would have recognized that the threshold at which a patient’s inhalation effort is considered sufficiently record to warrant modification of therapy is a result effective variable.
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 Blissenbach et al. to include wherein the post-exacerbation value of the inhalation parameter increases towards the baseline value during reversion to said baseline lung function, and wherein the inhalation parameter criterion is fulfilled by said post-exacerbation value being at least 70% of the baseline value as a matter of routine optimization that depends upon the desired level of clinical sensitivity and the desired balance in the stepwise approach for the clinical decision making to meet individual patient’s need since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05(II).
Regarding claim 18, Blissenbach et al. in view of NIH discloses the method of claim 30, as discussed above.
Modified Blissenbach et al. further discloses, wherein the pharmaceutical composition is in tablet form (Fig 4-8a-c, “5mg tablet…40-50 mg per day as single or 2 divided doses…”; Fig 4-8a-c, “5mg tablet…40-50 mg per day as single or 2 divided doses…”).
Regarding claim 21, Blissenbach et al. in view of NIH discloses the method of claim 30, as discussed above.
Blissenbach et al. further discloses, wherein the oral corticosteroid comprises prednisone or prednisolone (Col 9, ln 17- Col 10, ln 15, “cortisone, hydrocortisone, prednisone, triamcinolone, prednisolone, methylprednisolone, or dexamethasone”).
Regarding claim 22, Blissenbach et al. in view of NIH discloses the method of claim 21, as discussed above.
Modified Blissenbach et al. further discloses, wherein said initial dose is in the range of 5 to 60 mg daily for adults aged 18 years and older (NIH: PG 326-352, see section, “Managing asthma long term in Youth…and Adults”; Fig 4-8a-c, “5mg tablet…40-50 mg per day as single or 2 divided doses…”).
Regarding claim 26, Blissenbach et al. in view of NIH discloses the method of claim 21, as discussed above.
Modified Barrett et al. does not specifically discloses, wherein said initial dose is in the range of 40 to 50 mg daily for children aged 12 to 17 years.
However, Busse which is analogous art to the claimed invention for the guidelines of asthma control including treatment options such as long-acting β-agonists as adjunct therapy with inhaled corticosteroids (abstract) teaches, a dose of 40-80 mg/day in 1 or 2 divided for adults who are in age group over 12 years old for treating asthma exacerbation (Fig 22). Thus, said initial dose in for children aged 12 to 17 years is a result effective variable.
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 Barrett et al. to include wherein said initial dose is in the range of 40 to 50 mg daily for children aged 12 to 17 years as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II).
Regarding claim 27, Blissenbach et al. in view of NIH discloses the method of claim 21, as discussed above.
Modified Blissenbach et al. further discloses, wherein said initial dose is in the range of 1 mg/kg daily for children aged 1 month to 11 years (NIH: PG 281-318; Fig 4-4c, “1-2 mg/kg/day”).
Regarding claim 28, Blissenbach et al. in view of NIH discloses the method of claim 30, as discussed above.
Blissenbach et al. further discloses, wherein the respiratory disease is asthma (Col 8, ln 49-50, “the treatment of asthma”)
Claims 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Mishelevich et al. (US 5363842 A1).
Regarding claim 33, Mishelevich et al. discloses, a method comprising (a method of Figs 6A-6B, “processes for use of the intelligent inhaler by healthcare professional and patient”):
receiving a baseline value of an inhalation parameter indicative of a baseline lung function of a subject (Col 4, ln 40-55, “…compare the resultant time course to either (a) a standard target envelope (e.g., one or more of flow, volume, and time) for that medication or (b) a specific target envelope for that particular patient programmed into the intelligent inhalation device”);
receiving a value of the inhalation parameter determined from one or more inhalations performed by the subject using at least one inhaler (Col 4, ln 35-55, “how much air is inhaled through the inhaler with what time course (including such derived measurements as how much volume is inspired within the bounds of a given flow range) as well as certain events such as the triggering of the release of aerosol”; Col 11, ln 25-41, implies that measured values are compared with the target envelope and then determines the compliance and recorded);
controlling a user interface to communicate the baseline value (Col 10, ln 59 - Col 11, ln 25-41, a monitoring computer has a display means for displaying of the compliance data in view of the target envelope); and
controlling the user interface to communicate the value such as to permit comparison between the value and the baseline value (Col 10, ln 59 - Col 11, ln 25-41, implies the display provides comparison between actual data and the target envelope).
While Mishelevich et al. discloses the testing involving a group of acute asthmatic patient and observing the patients in terms of correct technique, and the medication, such as corticosteroid is taken over long periods of time rather than in an immediate reaction to an acute event, Mishelevich et al. is silent on the inhalers are used during a post-exacerbation.
However, the inhaler of Mishelevich et al. is capable of being used after an exacerbation event to improve treatment by monitoring the inhalation technique and providing feedback (Col 1, ln 8-19) in order to maximize the therapeutic response (Col 11, ln 25-41).
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 Mishelevich et al. to include the usage after the exacerbation event in order to maximize the therapeutic response (Col 11, ln 25-41).
Regarding claim 34, Mishelevich et al. discloses, a method comprising (a method of Figs 6A-6B, “processes for use of the intelligent inhaler by healthcare professional and patient”):
receiving a baseline rescue inhaler usage (Examiner interprets the “baseline rescue inhaler usage” broadly such as which encompasses any predetermined condition based on the subject’s use of the inhaler in BRI; Col 4, ln 40-55, “…compare the resultant time course to either (a) a standard target envelope (e.g., one or more of flow, volume, and time) for that medication or (b) a specific target envelope for that particular patient programmed into the intelligent inhalation device”; Examiner notes that the inhaler of Mishelevich et al. is capable of being used as a rescue inhaler as it is compatible with including bronchodilators, corticosteroids, anticholinergics, antibiotics, and others, as well as with systemically acting drugs as described in Col 12, ln 14-24);
receiving a rescue inhaler usage (Examiner notes that the Col 4, ln 35-55, “how much air is inhaled through the inhaler with what time course (including such derived measurements as how much volume is inspired within the bounds of a given flow range) as well as certain events such as the triggering of the release of aerosol”; Col 11, ln 25-41, implies that measured values are compared with the target envelope and then determines the compliance and recorded);
controlling a user interface to communicate the baseline rescue inhaler usage (Col 10, ln 59 - Col 11, ln 25-41, a monitoring computer has a display means for displaying of the compliance data in view of the target envelope); and
controlling the user interface to communicate the rescue inhaler usage such as to permit comparison between the rescue inhaler usage and the baseline rescue inhaler usage (Col 10, ln 59 - Col 11, ln 25-41, implies the display provides comparison between actual data and the target envelope).
While Mishelevich et al. discloses the testing involving a group of acute asthmatic patient and observing the patients in terms of correct technique, and the medication, such as corticosteroid is taken over long periods of time rather than in an immediate reaction to an acute event, Mishelevich et al. is silent on the inhalers are used during a post-exacerbation.
However, the inhaler of Mishelevich et al. is capable of being used after an exacerbation event to improve treatment by monitoring the inhalation technique and providing feedback (Col 1, ln 8-19) in order to maximize the therapeutic response (Col 11, ln 25-41).
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 Mishelevich et al. to include the usage after the exacerbation event in order to maximize the therapeutic response (Col 11, ln 25-41).
Regarding claim 35, Mishelevich et al. discloses the method of claim 33 as discussed above.
Mishelevich et al. further discloses, wherein said baseline value is determined from one or more inhalations using the at least one inhaler (Col 11, ln 12 - Col 12, ln 9, implies that the target envelope can be determined from a set of data, or physical parameters of the condition and capacity of a patient or manually set by the physician based on the feedback of the usage when the subject is not experiencing an exacerbation) when the subject is not experiencing an exacerbation.
Regarding claim 36, Mishelevich et al. discloses the method of claim 34 as discussed above.
Mishelevich et al. further discloses, wherein said baseline value is determined from one or more inhalations using the at least one inhaler (Col 11, ln 12 - Col 12, ln 9, implies that the target envelope can be determined from a set of data, or physical parameters of the condition and capacity of a patient or manually set by the physician based on the feedback of the usage when the subject is not experiencing an exacerbation) when the subject is not experiencing an exacerbation.
Conclusion
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/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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