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
Acknowledgement is made to Applicant’s claim to priority to National Stage App. PCT/EP2021/073171 filed August 20, 2021 and to Foreign App. No. GB 2013129.8 filed August 21, 2020.
Status of Claims
This Office Action is responsive to the preliminary amendment filed on February 10, 2023. As directed by the amendment: claims 1-4, 6-14, 17, and 20-22 have been amended; claims 5, 15, 16, 18, 19, and 24 have been cancelled; and claims 25-26 have been added. Thus, claims 1-4, 6-14, 17, 20-23, and 25-26 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “use determination system” claim 1, ln 3-4 and “sensor system” claim 1, ln 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 1-4, 6-14, 17, 20-23, and 25-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims recite an apparatus, a method, and a computer-readable storage medium 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 providing an output for warning of a respiratory disease exacerbation in a subject. The claims recite an abstract idea in the form of monitoring a frequency of the determined rescue inhalations; monitoring the parameter as a function of time, and providing the output if the parameter as a function of time is indicative of the lung condition of the subject deteriorating over a first time period, and the frequency of the determined rescue inhalations is higher during a second time period than during the first time period, the second time period being subsequent to the first time period. This represents a mental processes because it can equivalently be done by a person simply observing the frequency of the determined rescue inhalations, observing the parameter as a function of time and determine and alert depending as a function of time is indicative of the lung condition of the subject deteriorating depending on the timing of the rescue inhalations. This represents a mental processes because it can equivalently be done by a person simply observing frequency of the rescue inhalations and altering depending on the frequency of the rescue inhalations.
These 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 Claims 13 and 26, as a representative example that is applicable to claims 1-4, 6-12, 14, 17, 20-23, and 25, the abstract idea is defined by the elements of:
Claim 1:
A system for providing an output for warning of a respiratory disease exacerbation in a subject, the system comprising: a first inhaler for delivering a rescue medicament to the subject, the first inhaler having a use determination 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 said rescue inhalation; and a processor configured to: monitor a frequency of the determined rescue inhalations; monitor the parameter as a function of time, and provide the output if the parameter as a function of time is indicative of the lung condition of the subject deteriorating over a first time period, and the frequency of the determined rescue inhalations is higher during a second time period than during the first time period, the second time period being subsequent to the first time period.
Claim 13:
A method for providing an output for warning of a respiratory disease exacerbation in a subject, the method comprising: monitoring a frequency of rescue inhalations using an inhaler; monitoring a parameter relating to airflow as a function of time, the parameter being sensed during the rescue inhalations; and providing the output if the parameter as a function of time is indicative of the lung condition of the subject deteriorating over a first time period, and the frequency of rescue inhalations is higher during a second time period than during the first time period, the second time period being subsequent to the first time period.
Claim 26:
A computer-readable storage medium comprising computer-executable instructions that, when executed by a processor, cause the processor to: monitor a frequency of rescue inhalations using an inhaler; monitor a parameter relating to airflow as a function of time, the parameter being sensed during the rescue inhalations; and provide the output if the parameter as a function of time is indicative of the lung condition of the subject deteriorating over a first time period, and the frequency of rescue inhalations is higher during a second time period than during the first time period, the second time period being subsequent to the first time period.
The above bolded limitations recite an apparatus, a method, and a computer-readable storage medium for monitoring a frequency of the determined rescue inhalations; monitoring the parameter as a function of time, and providing the output if the parameter as a function of time is indicative of the lung condition of the subject deteriorating based on the frequency of the determined rescue inhalations.
The process of determining the output based on the frequency of the determined rescue inhalations if the parameter as a function of time is indicative of the lung condition of the subject deteriorating over a first time period, and the frequency of the determined rescue inhalations is higher during a second time period than during the first time period, the second time period being subsequent to the first time period 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 measuring through observations the frequency of the determined rescue inhalations and the parameter as a function of time, and are able to compare their observation to time thresholds to generate an output. This is further defining mental process in the form of observations, evaluations, judgments, and opinions.
Looking at monitoring the frequency of the determined rescue inhalations the monitoring the parameter as a function of time 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 “a system”, “a first inhaler”, “a use determination system,” “a sensor system”, and “a processor”, 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 “a sensor system,” and “a use determination system” which is used for extra solution data gathering and high-level of generality as stated in US 20090136788 A1 (para. 0006). Additionally, the use of “a system” and “a first inhaler,” are 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). For example, “a system” of high-level of generality shown in US 20090288663 A1 (para. 0002). In addition, the use of “processor” have limitations that are not indicative of integration into a practical application because they are 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.
A “use determination system” and “a sensor system”, which is used for extra solution data gathering; “processor” is general purpose computers; and “an inhaler,” are filed of use or extra solution activity that are also recited in Claims 13 and 26, are all 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 “processor” 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, 13, and 26 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 and control computer are generic computer systems and the ventilation system and breathing apparatus are drawn to a field of use.
Likewise, the rationale set forth for the 2nd prong of the eligibility test above for claims 1, 13, and 26 are also applicable to Claim 2-4, 6-12, 14, 17, 20-23, and 25.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-14, 17, 20, 21, 23, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Manice et al. (U.S. Pub. No. 2019/0385727; hereinafter: “Manice”) in view of Barrett et al. (U.S. Pub. No. 2019/0102522; hereinafter: “Barrett”).
Regarding Claims 1, 13, and 26, Manice discloses a system for providing an output for warning of a respiratory disease exacerbation in a subject (¶ 0072; Examiner notes: Manice discloses the system as to provide needed data and to facilitate anticipation of potential adverse respiratory events.), the system comprising: a first inhaler (25; Fig. 1) for delivering a rescue medicament to the subject (¶¶ 0026, 0071), the first inhaler having a use determination system (10, 46, 200; Fig. 1, 12) configured to determine a rescue inhalation performed by the subject using the first inhaler (“tracking module”; ¶¶ 0026-0031, 0071, 0098-0103, 0141, 0142); processor (30, 40, 46; Fig. 1, 6-10; ¶¶ 0100-0106) configured to: monitor a frequency of the determined rescue inhalations (¶¶ 0026-0033, 0071, 0072, 0100-0111); monitor the parameter as a function of time (¶¶ 0026-0033, 0071, 0072, 0100-0111), and provide the output if the parameter as a function of time is indicative of the lung condition of the subject deteriorating over a first time period (¶¶ 0026-0033, 0071, 0072, 0100-0111; Examiner notes: Manice discloses alerting to the patient of a potential adverse event or other complication, an alert regarding a change in the treatment regimen.).
Manice does not specifically disclose the system wherein the frequency of the determined rescue inhalations is higher during a second time period than during the first time period, the second time period being subsequent to the first time period.
Barrett teaches a system comprising a sensor system (120; Fig. 1) configured to measure a parameter relating to airflow during a rescue inhalation (160; Fig. 1; ¶¶ 0047, 0049-0052, 0056, 0057, 0060-0067); a processor (110; 205; Fig. 1, 2) configured to: monitor a frequency of the determined rescue inhalations (¶¶ 0051, 0052, 0064, 0065, 0074-0079, 0082, 0100-0111); monitor the parameter as a function of time (¶¶ 0051, 0052, 0064, 0065, 0074-0079, 0082, 0100-0111), and provide the output if the parameter as a function of time is indicative of the lung condition of the subject deteriorating over a first time period (¶¶ 0112-0125, 0138-0143), and the frequency of the determined rescue inhalations is higher during a second time period than during the first time period, the second time period being subsequent to the first time period (¶¶ 0051, 0052, 0064, 0065, 0074-0079, 0082, 0092-0125, 0138-0143; Fig. 6C-7A; Examiner notes: Barrett discloses utilizing the time period as a range bounded by the current day and seven days prior or a time period preceding the time of a current/most recent rescue usage event to calculate the risk of deterioration.) for the purpose of identifying complex combination of input values that lead to more usage of a rescue inhaler in order to avoid them in the future and generate notifications that are specifically configured to be sent to a patient in a sufficiently timely manner to hopefully avoid the occurrence of an asthma event that would necessitate usage of their rescue inhaler (¶¶ 0121, 0142).
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 Manice to include the frequency of the determined rescue inhalations is higher during a second time period than during the first time period, the second time period being subsequent to the first time period as taught by Barrett for the purpose of identifying complex combination of input values that lead to more usage of a rescue inhaler in order to avoid them in the future and generate notifications that are specifically configured to be sent to a patient in a sufficiently timely manner to hopefully avoid the occurrence of an asthma event that would necessitate usage of their rescue inhaler (See Barrett: ¶¶ 0121, 0142).
Regarding Claims 2 and 14, the modified device of Manice discloses the system further comprising a user interface [See Manice: a smartphone running an application (“app”) 46; Fig. 1, 6-10; ¶ 0103-0111, See Barrett: 300, 300a; Fig. 3A, 33B], wherein the processor is configured to control the user interface to issue an exacerbation warning based on said output being provided (See Manice: ¶¶ 0104-0107, See Barrett: ¶¶ 0094-0103: “cards”).
Regarding Claim 3, the modified device of Manice discloses the system further comprising a user interface [See Manice: a smartphone running an application (“app”) 46; Fig. 1, 6-10; ¶¶ 0103-0111, See Barrett: 115, 300, 300a; Fig. 1, 3A, 33B] configured to enable user-inputting of an indication of a status of a respiratory disease being experienced by the subject (See Manice: ¶¶ 0103-0111, See Barrett: ¶¶ 0054, 0096-0102), and wherein the processor is configured to control the user interface to issue a prompt to input said indication based on said output being provided (See Manice: ¶¶ 0103-0111, See Barrett: ¶¶ 0054, 0096-0102).
Regarding Claim 4, the modified device of Manice discloses the system wherein the processor is configured to control the user interface to issue an exacerbation warning based on said output being provided (See Manice: ¶¶ 0104-0107, See Barrett: ¶¶ 0094-0103: “cards”).
Regarding Claim 6, the modified device of Manice discloses the system wherein the user interface is configured to provide a plurality of user-selectable respiratory disease status options (See Manice: ¶¶ 0104-0111, See Barrett: ¶¶ 0092-0125, 0138-0143), wherein the indication is defined by user-selection of at least one of said status options (See Manice: ¶¶ 0104-0111, See Barrett: ¶¶ 0092-0125, 0138-0143).
Regarding Claim 7, the modified device of Manice discloses the system wherein the user interface is configured to provide said status options in the form of selectable icons, checkboxes, a slider,
Regarding Claim 8, the modified device of Manice discloses the system wherein the parameter is at least one of a peak inhalation flow, an inhalation volume, a time to peak inhalation flow, or and an inhalation duration (See Manice: ¶¶ 0026-0031, 0071, 0098-0103, 0141, 0142).
Regarding Claim 9, the modified device of Manice discloses the system wherein the sensor system comprises a pressure sensor (See Manice: 114; Fig. 11, 16); and
Regarding Claim 10, the modified device of Manice discloses the system wherein the use determination system comprises a mechanical switch (See Manice: 16; Fig. 2) configured to be actuated prior to, during, or after use of the first inhaler (See Manice: ¶¶ 0075, 0077, 0088, 0099, 0118, 0119, 0121, 0123-0125).
Regarding Claim 11, the modified device of Manice discloses the system wherein the first inhaler comprises: a medicament reservoir (See Manice: 15, 106; Fig. 2, 11); and a dose metering assembly (See Manice: 103, 108; Fig. 11) configured to meter a dose of said medicament from the reservoir (See Manice: ¶¶ 0113-0116), wherein the use determination system is configured 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 (See Manice: ¶¶ 0026-0033, 0071, 0072, 0100-0119, 0121, 0123-0125).
Regarding Claim 12, the modified device of Manice discloses the system wherein the first inhaler is configured to deliver a rescue medicament comprising albuterol, formoterol, budesonide combined with formoterol, beclomethasone combined with albuterol, or
Regarding Claim 17, the modified device of Manice discloses the method further comprising providing the
Regarding Claim 20, the modified device of Manice discloses the method further comprising treating said respiratory disease based on the output being provided (See Manice: ¶¶ 0021, 0100-0119, See Barrett: ¶¶ 0134, 0169, 0170).
Regarding Claim 21, the modified device of Manice discloses the method wherein the treating comprises switching the subject from a first treatment regimen to a second treatment regimen following a determination
Regarding Claim 23, the modified device of Manice discloses the method wherein the treating comprises switching the subject from a first treatment regimen to a third treatment regimen based on the output not being provided for a predetermined period of time (See Barrett: ¶¶ 0106, 0107, 0123, 0124, 0148-0150), wherein the third treatment regimen is configured for lower risk of a respiratory disease exacerbation than the first treatment regimen (See Barrett: ¶¶ 0106, 0107, 0123, 0124, 0148-0150).
Regarding Claim 25, the modified device of Manice discloses the system further comprising: a second inhaler (See Manice: 20; Fig. 1) for delivering a maintenance medicament to the subject during a routine inhalation (See Manice: ¶ 0071), wherein the sensor system is configured to measure a parameter relating to airflow during said routine inhalation using the second inhaler when included in the system (See Manice: ¶¶ 0067, 0071, 0073, 0074, 0092); and wherein the processor is configured to: monitor the parameter relating to airflow during said routine inhalation as a function of time (See Manice: ¶¶ 0026-0033, 0071, 0072, 0100-0106, 0107-0111); and provide the output if the parameter relating to airflow during said routine inhalation as a function of time is indicative of the lung condition of the subject deteriorating over a first time period (See Manice: ¶¶ 0026-0033, 0071, 0072, 0100-0106, 0107-0111, See Barrett: ¶¶ 0112-0125, 0138-0143), and the frequency of the determined routine inhalations is higher during a second time period than during the first time period, the second time period being subsequent to the first time period (See Barrett: ¶¶ 0051, 0052, 0064, 0065, 0074-0079, 0082, 0092-0125, 0138-0143; Fig. 6C-7A).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Manice in view of Barrett as applied to claim 21 above, and further in view of Levy et al. (U.S. Pat. No. 8,342,172; hereinafter: “Levy”).
Regarding Claim 22, the modified device of Manice discloses the method, shown above.
The modified device of Manice does not specifically disclose the method wherein the second treatment regimen comprises administering a biologics medication, and wherein said biologics medication comprises or dupilumab.
Levy teaches a treat regimen comprising administering a biologics medication(col 4, ln 15-36), wherein said biologics medication comprises omalizumab (col 4, ln 15-36) for the purpose of delivering a second drug in an attempt to avert or reduce the severity of an asthma condition (col 4, ln 15-36).
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 method of the modified device of Manice to include the second treatment regimen comprising administering the biologics medication being omalizumab as taught by Levy for the purpose of delivering a second drug in an attempt to avert or reduce the severity of an asthma condition (See Levy: col 4, ln 15-36).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Barrett et al. (U.S. Pub. No. 2019/0189258) discloses dynamic graphical user interface for interaction with patient respiratory disease data.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785