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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (GB1906078.9) filed on the April 30, 2019.
Response to Amendment
This office action is responsive to the amendment filed as January 06, 2026. As directed by the amendment: claims 1 and 17 have been amended, claim 23 have been canceled, and claim 24 have been added. Thus, claims 1-6, 11-13, 17, and 24 are presently pending in the application.
Response to Arguments
Applicant argues on page 8-9 of the remarks that the 112(a) and 112(b) rejections on the claims. Previously, examiner states that the claim has an indefinite issue. Applicant has amended that claim to advance prosecution. Applicant response is persuasive, the previous 112(a) and 112(b) rejections has been hereby withdrawn.
Applicant argues on page 10-11 of the remarks that the 101-rejection made needs to be withdrawn. Applicant explains that the claim limitations cannot be performed in human mind and there is no way for a human mind to measure airflow and different measurement by the sensor as claimed. Examiner respectfully disagrees. The 101 rejections made on claim 1 and 17 are not asserting that the data the sensors collects could be accomplished in the mind of a person. The 101 rejection is explaining that the process of a person simply observing the output of the different parameters that can be to measure a probability of COPD. Furthermore, determining a probability of a COPD exacerbation in a subject, determining a number of said rescue inhalations during a first time period, receive said parameter measured for at least some of said rescue inhalations, routine inhalations, or both; and determining said probability of the COPD exacerbation based on said number of rescue inhalations and said parameters, the parameters having more importance in the probability determination than the number of rescue inhalations can be carried out in a person’s mind. This process is nothing more than a general link to a technological environment and generic computing devices to perform generic communicating functions such as storing data and instructions, transmitting and receiving data between computers. The person is reviewing and using the data. If a claim recites such limitations, which under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic bioelectric sensors, then it falls within the “Mental Processes” of grouping abstract. People (patients or doctor or caregivers) are capable of measuring through observations the different parameters and come to a conclusion of probability of COPD of the subject. This is further defining mental process in the form of observations, evaluations, judgments, and opinions. This is indicative of the fact that the claim has not integrated the abstract idea into a practical application and therefore the claim is found to be directed to the abstract idea identified by the examiner (MPEP 2106.04).
New claim 24 have been entered and rejected below.
Claim Objections
Claim 24 objected to because of the following informalities:
Regarding Claim 24, “The system according to claim 1, wherein the model has a first weighting coefficient associated with the number of rescue inhalations and a second weighting coefficient associated with the parameter, the first weighting coefficient being larger than the second weighting coefficient.” Should read – The system according to claim 1, wherein the model has a first weighting coefficient associated with the parameter and a second weighting coefficient associated with the number of rescue inhalations, the first weighting coefficient being larger than the second weighting coefficient.—
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 11-13, and 17, and 24 are rejected under 35 U.S.C. 101 because he claimed invention is directed to an abstract idea without significantly more.
The claims recite a system satisfying two of the statutory categories; therefore, the claims pass step 1 of the eligibility analysis. For step 2A, the claim(s) are directed to a system for determining a probability of a COPD exacerbation in a subject. The claims recite an abstract idea in the form of the first inhaler having a use-detection system configured to determine a rescue inhalation performed by the subject using the first inhaler; a sensor system configured to measure a parameter relating to airflow during at least one of (i) said rescue inhalation or (ii) said routine inhalation using a second inhaler for delivery maintenance medicament to the subject; determine a number of said rescue inhalations during a first time period; receive said parameter measured for at least some of said rescue inhalations, routine inhalations, or both; and determine, using a model, said probability of the COPD exacerbation based on said number of rescue inhalations and said parameters, the parameters having more importance in the probability determination than the number of rescue inhalations. This represents a mental processes because it can equivalently be done by a person simply observing how many rescues inhalation that happen within a time period and then determining a parameter in relation to probability of COPD which is are actions that a person could do purely in the mind. If a claim recites a limitation, which under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
Using Claim 1, also applicable to Claim 17, as a representative example that is applicable to claims 2-6 and 11-13, and 24 the abstract idea is defined by the elements of:
Claim 1:
A system for determining a probability of a COPD exacerbation in a subject, the system comprising:
a first inhaler for delivering a rescue medicament to the subject, the first inhaler having a use-detection system configured to determine a rescue inhalation performed by the subject using the first inhaler;
wherein the system comprises a sensor system configured to measure a parameter relating to airflow during at least one of (i) said rescue inhalation or (ii) a routine inhalation using a second inhaler for delivery maintenance medicament to the subject; and a processor configured to:
determine a number of said rescue inhalations during a first time period; receive measurements of said parameter measured for at least some of said rescue inhalations, routine inhalations, or both;
and determine, using a model, said probability of the COPD exacerbation based on said number of rescue inhalations and the measurements of said parameter, wherein the model is constructed such that the measurements of said parameter have having more importance in the probability determination than the number of rescue inhalations.
Claim 17:
A computer-readable medium having stored thereon instructions that, when executed by a control circuit, cause the control circuit to:
receive a number of rescue inhalations of a rescue medicament performed by a subject during a first time period;
receive measurements of a parameter relating to airflow during at least some of the rescue inhalations, routine inhalations performed by the subject of a maintenance medicament or both;
and determine, using a model, a probability of a COPD exacerbation in the subject based on said number of rescue inhalations and said measurements of the parameter, wherein the model is constructed such that the measurements of the parameter have having more importance in the probability determination than the number of rescue inhalations.
The above bolded limitations recite a system for determining a probability of a COPD exacerbation in a subject, determining a rescue inhalation performed by the subject using the first inhaler, measuring a parameter relating to airflow during at least one of (i) said rescue inhalation ii) said routine inhalation, determining a number of said rescue inhalations during a first time period, receive said parameter measured for at least some of said rescue inhalations, routine inhalations, or both; and determining said probability of the COPD exacerbation based on said number of rescue inhalations and said parameters, the parameters having more importance in the probability determination than the number of rescue inhalations, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The process of determining a probability of a COPD exacerbation in a subject, determining a number of said rescue inhalations during a first time period, receive said parameter measured for at least some of said rescue inhalations, routine inhalations, or both; and determining said probability of the COPD exacerbation based on said number of rescue inhalations and said parameters, the parameters having more importance in the probability determination than the number of rescue inhalations can be carried out in a person’s mind. This is further defining the abstract idea.
Furthermore, this is a process known to be capable of being performed by people mentally, and not limited to be carried out via computer for automation. People (patients or doctor or caregivers) are capable of determining a probability of a COPD exacerbation in a subject, determining a rescue inhalation performed by the subject using the first inhaler, measuring a parameter relating to airflow during at least one of (i) said rescue inhalation ii) said routine inhalation, and determining a number of said rescue inhalations during a first time period, receive parameters and determining said probability of the COPD exacerbation based on said number of rescue inhalations and said parameters. This is further defining mental process in the form of observations, evaluations, judgments, and opinions. Searching a set of messages to locate either a message evidencing that the payment card transaction was completed or a message evidencing that a product was shipped to the customer can be carried out manually. This is considered longstanding practice that is the focus of the (patent ineligible) claimed invention and is further defining the abstract idea. The mere nominal recitation of “processor”, “a system” “sensor system”, “use-detection system” , “inhaler”, “a model” , does not take the claim out of the group of mental processes.
This judicial exception is not integrated into a practical application (2nd prong of eligibility test for step 2A) because the additional elements of the claim amount to the use of “use-detection system” , “sensor system”, which is used for extra solution data gathering. Additionally, the use of “system” is field of use and/or extra solution activity these are merely being used as a tool to execute the abstract idea, see MPEP 2106.05(f). In addition, the use of “processor” has limitations that are not indicative of integration into a practical application because it is being recited at a high-level of generality as shown in US 20170182267 A1 (para. 0148) (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component. This is indicative of the fact that the claim has not integrated the abstract idea into a practical application and therefore the claim is found to be directed to the abstract idea identified by the examiner.
Likewise, the rationale set forth for the 2nd prong of the eligibility test above for claim 1 is also applicable to Claims 2-6 and 11-13. In regards to Claims 2-3, the applicant is reciting elements that further limit the claims to include wherein the probability of the COPD exacerbation is the probability of the COPD exacerbation occurring within an exacerbation period subsequent to said first time period. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 4-6, the applicant is reciting elements that further limit the claims to include determine an average peak inhalation flow from peak inhalation flows measured for rescue inhalations, routine inhalations, or both performed during a second time period, and wherein the probability of the COPD is partially based on said average peak inhalation flow. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 11-12, the claim recites a new additional element of “a pressure sensor” which is used for extra solution data gathering. Further, the pressure sensor is not significantly more for the reasons set forth above concerning the sensors as a broad class. For step 2B, the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using a pressure sensor or different parts of the inhaler to perform steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f).
In regards to Claim 13, the claim recites a new additional element of “a user interface” which is routine and conditional. Further, the user interface is not significantly more for the reasons set forth above concerning the computer, processor, or user interface as a broad class. For step 2B, the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using the user interface to perform steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f).
In regards to Claim 24, No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claim. Further, the model is not significantly more for the reasons set forth above concerning the computer, processor, or user interface as a broad class. For step 2B, the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using the user interface to perform steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f).
A “a control circuit,” in claim 17 is a general purpose computer which is considered nothing more than a general link to a technological environment and generic computing devices to perform generic communicating functions such as storing data and instructions, transmitting and receiving data between computers. The “a model” is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component; for example, the additional elements are directed to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea identified by the examiner.
For step 2B, the independent claim(s) Claims 1 and 17 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using a computer to carry out the steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f). The additional elements did not add significantly more to the abstract idea because they were simply applying the abstract idea on a computer 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. The processor is a generic computer systems and the inhaler is drawn to a field of use.
Claim 17 is additionally rejected under 101 because, it is not directed to a statutory category of a process, machine, manufacture or composition of matter. In addition, the claim recites a new additional element of “a computer-readable medium” which considered nothing more than a general link to a technological environment and generic computing devices to perform generic communicating functions such as storing data and instructions, transmitting and receiving data between computers. For step 2B, the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using a computer to perform steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 11-13, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (US 20160314256 A1), hereafter as Su in view of Manice et al. (US 20190385727 A1), hereafter as Manice, and Canvin et al. ((US 20180056018 A1), hereafter as Canvin, and Su et al. (US 10726954 B2), hereafter as Su II.
Regarding Claim 1, Su discloses a system for determining a probability of a COPD exacerbation in a subject (abstract; para. 0030, 0071-0073), the system comprising:
a first inhaler (Fig. 1; medical device 160; para. 0029-0031, 0035-0037) for delivering a rescue medicament to the subject (para. 0030; Examiner notes: the inhaler uses sensors to sense and deliver a dose of medication),
the first inhaler having a use-detection system (Fig. 1; sensor 120; para. 0022-0023, 0027—0028, 0031-0038) configured to determine a rescue inhalation performed by the subject using the first inhaler (Examiner notes: this limitation is functional the sensor is used to determine if the dosage is given);
and a processor (Fig. 1, 2; network 150, application server 130, application 110; para. 0026, 0036, 0040-0051) configured to (Examiner notes: these next limitations are functional):
determine a number of said rescue inhalations during a first time period (para. 0022-0023, 0038; Examiner notes: the processor tracks and storages data in relations to rescues inhalations that are administered);
receive measurements of said parameter measured for at least some of said rescue inhalations, routine inhalations (para. 0076-0078), or both; and
and determine, using a model (Fig. 1B; application server 130; para. 0020, 0035, 0040-0051) said probability of the COPD exacerbation based on said number of rescue inhalations and measurements said parameters (para. 0040-0051, 0071-0073).
Su does not specifically disclose wherein the system comprises a sensor system configured to measure a parameter relating to airflow during said rescue inhalation and wherein the model is constructed such that the measurements of the parameter have having more importance in the probability determination than the number of rescue inhalations.
However, Manice teaches wherein the system comprises a sensor system (Fig 1, 3A-3C; tracking module 10; para. 0038, 0092), configured to measure a parameter relating to airflow during at least one of (i) said rescue inhalation (para. 0092; Examiner notes: this limitation is functional however the tracking module it used for tracking different parameters from the inhaler); rescues inhalation is when the parameter is taken and that the parameters having more importance in the probability determination than the number of rescue inhalations (Examiner notes: since the system is only using parameters to determine the probability, the parameters have “more” importance; para. 0090).
Canvin teaches a device for managing drug therapy to treat COPD (para. 0030) wherein the process is configured to compare signals received from a sensor and/or determined inhalation peak flow to assess how the inhaler is being used and whether the use is likely to result in delivery of a full dose of medication (para. 38-39).
Su II teaches a processor determining said probability of the COPD exacerbation partially based on peak flow (Col. 11 line 58-Col. 12 line 67; Table 3, COPD characteristics – peak flow).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Su wherein the parameter measured of said rescue inhalations is from a sensor system configured to measure a parameter relating to airflow during at least one of said rescue inhalation as taught by Manice, Canvin and SuII because of following:
1) Manice teaches tracker module using a sensor system that measures airflow parameters in rescue inhalers to determine use and risk related to COPD (para. 0092, 0098 and 0105); and
2) Canvin and Su II teach that the airflow parameter such as inhalation peak flow are associated with COPD treatment (Canvin) and probability (Su II).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the system of Su wherein and that parameters (airflow) having more importance in the probability determination than the number of rescue inhalations because in the system of Manice airflow characteristics are the only parameters considered in tracking as taught by Manice for the purpose of measuring pressure of air flowing through the inhaled-air passage during an inhalation, storing in the tracking module memory the sensed pressure of air flow with an associated time/date stamp, and programming a local device that is in electrical communication with the tracking module to receive the stored dose data and associated time stamps and inhaled-air data and associated time/date stamps, and processing the received dose data and the inhaled-air data with respective time stamps together (0038); and being able to know when to administer medicament to the patient when they are having difficulty breathing or having an asthma attack (para. 0092).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Su to include wherein the parameter is at least one of peak inhalation flow as taught by Canvin for the purpose of monitoring the user's compliance, as a user suffering from asthma may produce different inhalation flow features than a healthy user breathing normally and he long term development of a health condition and/or a disease may be monitored (para. 0041, 0057).
Regarding Claim 2, Modified Su discloses the system according to claim 1, wherein the probability of the COPD exacerbation is the probability of the COPD exacerbation occurring within an exacerbation period subsequent to said first time period (para. 0070-0074, 0077; Examiner notes: the input data is described to may be time dependent over many different times; Su).
Regarding Claim 3, Modified Su discloses the system according to claim 1, wherein the first time period is 1 to 30 days (para. 0077; Su).
Regarding Claim 4, Modified Su discloses the system according to claim 1,
Modified Su does not specifically disclose wherein the parameter is at least one of a peak inhalation flow.
However, Canvin wherein the parameter is at least one of a peak inhalation flow (para. 0038).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Su to include wherein the parameter is at least one of a peak inhalation flow as taught by Canvin for the purpose of monitoring the user's compliance, as a user suffering from asthma may produce different inhalation flow features than a healthy user breathing normally and he long term development of a health condition and/or a disease may be monitored (para. 0041, 0057).
Regarding Claim 5, Modified Su discloses the system according to claim 4, wherein the probability of the COPD is partially based on parameter (para. 0040-0051, 0071-0073; Canvin).
Modified Su does not specifically wherein the processor is further configured (this limitation is functional) to determine an average peak inhalation flow from peak inhalation flows measured for rescue inhalations performed during a second time period.
However, Canvin teaches wherein the processor is further configured (this limitation is functional) to determine an average peak inhalation flow from peak inhalation flows measured for inhalations (para. 0038, 0039) performed during a second time period (para. 0057).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Su to include wherein the processor is further configured (this limitation is functional) to determine an average peak inhalation flow from peak inhalation flows measured for inhalations as taught by Canvin for the purpose of determining if that the inhalation is “good”, or likely to result in a full dose of medication being delivered and to a measure of the lung function or lung health of the patient (para. 0030, 0038-0040).
Regarding Claim 6, Modified Su discloses the system according to claim 5, wherein the processor is configured to (this limitation is functional) determine a change in the average peak inhalation flow relative to a baseline peak inhalation flow (para. 0038-0040; Canvin).
However, Modified Su does not specifically disclose said probability of the COPD exacerbation partially based on that change.
However, Su II teaches a processor determining said probability of the COPD exacerbation partially based on that change of a parameter (Col. 11 line 58-Col. 12 line 67; Table 3, COPD characteristics – peak flow; Col. 21 line 40-53).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Su to include wherein the processor is further configured (this limitation is functional) to determine said probability of the COPD exacerbation partially based on that change as taught by Su II for the purpose of providing information to patients, family members, healthcare providers. Provide to local healthcare system partners so that they can predict when respiratory disease-related utilization may occur and plan for staffing or space needs in their health facilities and to estimates about when an individual might experience a healthcare utilization in the future due to a combination of information such as adherence in the past week or month (Col. 32 lines 4-19).
Regarding Claim 11, Modified Su discloses the system according to claim 1,
Su does not specifically disclose wherein the sensor system comprises a pressure sensor; wherein the use-detection system comprises a further pressure sensor, the pressure sensor and the further pressure sensor being the same as or different from each other.
However, Manice teaches wherein the sensor system comprises a pressure sensor (Fig. 3C; para. 0027-0029, 0032, 0099); wherein the use-detection system comprises a further pressure sensor, the pressure sensor and the further pressure sensor being the same as or different from each other (para. 0099).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Su to include wherein the sensor system comprises a pressure sensor; wherein the use-detection system comprises a further pressure sensor, the pressure sensor and the further pressure sensor being the same as or different from each other as taught by Manice for the purpose of detecting movement of the canister to activate it to administer a dose of medicine and senses medication exiting the inhaler and dose is being given or flow determination (para. 0027 and 0099).
Regarding Claim 12, Modified Su discloses the system according to claim 1, wherein the first inhaler comprises: a medicament reservoir; and a dose metering assembly configured to meter a dose of said medicament from the reservoir (para. 0030; Su), wherein the use-detection system (Fig. 1; sensor 120; para. 0022-0023, 0027—0028, 0031-0038) is configured (This limitation is functional) to register the metering of said dose by the dose metering assembly, each metering being thereby indicative of said rescue inhalation performed by the subject using the first inhaler (Fig. 1; medical device 160; para. 0029-0031, 0035-0037; examiner notes: there is controller or rescues medication event that can depending on what inhaler is used for (para. 0035)).
Regarding Claim 13, Modified Su discloses the system according to claim 1, further comprising a user interface (Fig 1A; application 115; para. 0025, 0124) for inputting an indication of a status of the respiratory disease being experienced by the subject (Fig. 1A-1B; para. 0025-0026, 0050), wherein the processor (Fig. 1, 2; network 150, application server 130, application 110; para. 0026, 0036, 0040-0051) is configured to determine, using said model, said probability of the COPD exacerbation based on said number of rescue inhalations, said parameters, and said received indication (Examiner notes: This limitation is functional; the processor is able determine different parameters basic on the number of rescue inhalation, para. para. 0022-0023, 0038, 0076-0078).
Regarding Claim 17, Su discloses a computer-readable medium having stored thereon instructions that, when executed by a control circuit, cause the control circuit to:
receive a number of rescue inhalations of a rescue medicament performed by a subject during a first time period (para. 0030; para. 0070-0074, 0077; Examiner notes: the input data is described to may be time dependent over many different times, the inhaler uses sensors to sense and deliver a dose of medication);
and determine, using a model, a probability of a COPD exacerbation in the subject based on said number of rescue inhalations and measurements of said parameters (Fig. 1B; application server 130; para. 0020, 0035, 0040-0051) said probability of the COPD exacerbation based on said number of rescue inhalations and said parameters (para. 0040-0051, 0071-0073),
Su does not specifically disclose receive a parameter relating to airflow during at least some of the rescue inhalations; and wherein the model is constructed such that the measurements of the parameter have having more importance in the probability determination than the number of rescue inhalations.
However, Manice teaches wherein the system comprises a sensor system (Fig 1, 3A-3C; tracking module 10; para. 0038, 0092), configured to measure a parameter relating to airflow during at least one of said rescue inhalation (para. 0092; Examiner notes: this limitation is functional however the tracking module it used for tracking different parameters from the inhaler); the parameters having more importance in the probability determination than the number of rescue inhalations (Examiner notes: since the system is only using parameters to determine the probability, the parameters have “more” importance; para. 0090).
Canvin teaches a device for managing drug therapy to treat COPD (para. 0030) wherein the process is configured to compare signals received from a sensor and/or determined inhalation peak flow to assess how the inhaler is being used and whether the use is likely to result in delivery of a full dose of medication (para. 38-39).
Su II teaches a processor determining said probability of the COPD exacerbation partially based on peak flow (Col. 11 line 58-Col. 12 line 67; Table 3, COPD characteristics – peak flow).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Su wherein the parameter measured of said rescue inhalations is from a sensor system configured to measure a parameter relating to airflow during at least one of said rescue inhalation as taught by Manice, Canvin and SuII because of following:
1) Manice teaches tracker module using a sensor system that measures airflow parameters in rescue inhalers to determine use and risk related to COPD (para. 0092, 0098 and 0105); and
2) Canvin and Su II teach that the airflow parameter such as inhalation peak flow are associated with COPD treatment (Canvin) and probability (Su II).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the system of Su wherein and that parameters (airflow) having more importance in the probability determination than the number of rescue inhalations because in the system of Manice airflow characteristics are the only parameters considered in tracking as taught by Manice for the purpose of measuring pressure of air flowing through the inhaled-air passage during an inhalation, storing in the tracking module memory the sensed pressure of air flow with an associated time/date stamp, and programming a local device that is in electrical communication with the tracking module to receive the stored dose data and associated time stamps and inhaled-air data and associated time/date stamps, and processing the received dose data and the inhaled-air data with respective time stamps together (0038); and being able to know when to administer medicament to the patient when they are having difficulty breathing or having an asthma attack (para. 0092).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Su to include wherein the parameter is at least one of peak inhalation flow as taught by Canvin for the purpose of monitoring the user's compliance, as a user suffering from asthma may produce different inhalation flow features than a healthy user breathing normally and he long term development of a health condition and/or a disease may be monitored (para. 0041, 0057).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Su, Manice, Canvin, and Su II, as applied to claim 1, in view of Naya et al. (US 20080242954 A1), hereafter as Naya.
Regrading Claim 24, Modified Su system according to claim 1,
Modified Su does not teach wherein the model has a first weighting coefficient associated with the parameter and a second weighting coefficient associated with the number of rescue inhalations, the first weighting coefficient being larger than the second weighting coefficient.
However, Naya teaches a model that is a obtains a first value and second value and weighs one more heavily then the other. While the first coefficient is multiplied by certain value and the second coefficient is multiplied by a second value (para. 0061).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the model with the parameters of Modified Su to include the model that is able to weigh one value higher than another when trying to get an end result as taught by Naya for the purpose of being about to control and determine an expected condition (para. 0091).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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, KENDRA CARTER can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAAP ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785