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 .
Information Disclosure Statement
The information disclosure statements have been considered. Applicant should note that the excessively large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Objections
Claims 6, 7, 9, 11, 12 and 23-31 are objected to because of the following informalities:
Claim 11 does not accurately show all changes to the text of the claim as required by 37 CFR 1.121; this failure to present proper amendments will be accepted this one time in the interest of compact prosecution but future submissions that also fail to comply with 37 CFR 1.121 may be considered non-responsive. Further, any other claims which do not have properly indicated amendments will not be treated as having been amended unless otherwise noted below.
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Claim 6 recites “outputting and displaying the pulmonary health management information to a graphical user interface” – how does one display information to a GUI? Information can be outputted to a GUI, and displayed on a GUI, but it does not appear possible to display information to a GUI.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 7, 9, 11, 12 and 23-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 now calls for “instructing the user” to take “a set number of deep breaths” and then later calls for dispensing a fluid “during a dosing inhalation” and receiving various measurements “during an inspiratory measuring inhalation” and “during an exhalation”. It is unclear if any or all of these inhalations and exhalation are part of the “set number of deep breaths” or if they are performed subsequent to taking the deep breaths. If separate from the deep breaths, it is unclear why instruction is provided only for taking the deep breaths but not taking any other breath involved in the method. Clarification is required.
Claim 6 recites “during user initialization inhalation” – is this the same period as “taking a set number of deep breaths”? If the same, the claim should more clearly define that the inhalations during “deep breaths” during “to initialize the device” are considered “user initialization inhalation”; for the purposes of examination the claim will be treated as such but clarification is required.
Claim 6 refers to “breath actuated ejection of fluid from the piezoelectric driven ejector” but then calls for “dispensing the dose of the fluid and ejecting droplets from the ejector”. It is unclear if the fluid and the droplets are the same object, or if the droplets are ejected in addition to dispending the dose of the fluid. Further, it is unclear whether dispensing the dose of the fluid is the same activity as ejection of the fluid, as dispensing is recited separately from ejecting. Clarification is required.
Claim 11 now calls for “repeating the steps of” receiving measurements and generating information to track a change over time; this appears to have omitted the process of performing measurements at different times, as this merely calls for receiving the same data at a later time, such that as presented there would be no change as the data is simply received again. If the intent is to actually track changes over time the claim should call for receiving data from subsequent/later/different inhalations/exhalations; for the purposes of examination the claim will be treated as such but correction is required.
Claim 23 calls for a server to receive “the pulmonary health management information from one or more inhalation devices communicatively coupled to the computer server”. Claim 6 only calls for use of one inhalation device, such that it is not clear how more than one inhalation device might be involved. Further, per claim 6 the pulmonary health management information is generated by a computing unit and output to an interface, but does not call for the computing unit to also output the information to the inhalation device – as presented the inhalation device is used only for delivering a dose and obtaining information, not generating the pulmonary health management information, such that it is not clear how the device could still be configured to send that information to the server. This issue is also found in claims 28-31.
Claim 23 further refers to “an air analyzer application running the computer server” – it is unclear if the intent is actually to have an application running the server, or to define an application running on the server. Clarification is required. This issue is also found in claims 28-31.
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 6, 7, 9, 11, 12 and 23-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a process, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 6 recites a method comprising providing instructions to initialize a piezoelectric driven ejector inhalation device to initialize the device by taking a number of breaths, determining a trigger point to actuate ejection of fluid with the device, automatically dispensing the fluid when the trigger point is reached during a “dosing inhalation”, receiving a peak inspiratory flow measurement achieved during an “inspiratory measuring inhalation”, receiving a pulmonary output determining by measuring a maximum flow achieved during an exhalation on the device, generating “pulmonary health management information” using at least one computing unit communicatively coupled to the device which includes a “pulmonary health profile” generated based on the peak inspiratory flow and the pulmonary output, and outputting the “pulmonary health management information” to an interface for display.
The dependent claims (claims 17-30) appear to be encompassed by the abstract idea of the independent claims since they merely indicate generating additional information (claims 26, 27), processing the data (claims 12, 25), obtaining additional data and generating additional information based on the additional data (claims 7, 9, 11, 23, 28-31), outputting a result (claim 24).
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and processing data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the observation and evaluation of breathing data to generate pulmonary health information – a judgment or opinion regarding health.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 6 recites calibration of an inhalation device for optimally delivering a dose of fluid, acquiring breathing data during inhalation and exhalation, using a “computing unit” to evaluate the data, and outputting the result of the evaluation of the data. This judicial exception is not integrated into a practical application because generation of management information
Does not provide any improvement to technology, as it is merely the manipulation of data
Does not apply or use the judicial exception to effect a particular treatment, as the determined information is not used in any manner and only output in some unidentified manner without use of any particular element for this purpose; at best the delivery of a dose of fluid is provided at a determined “trigger point” but there is no specificity as to how this trigger point is determined from any gathered data
Is not applied with or by use of a particular machine, as the information is merely generated using a “computing unit” to provide a technological environment for execution of the abstract idea itself (see MPEP 2106.05(d), Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."), showing that these computer functions are well-understood, routine, and conventional functions), and an “inhalation device” that is used for obtaining data during breathing
Does not effect any transformation of a particular article, as the generation of nonspecific management information is merely a disembodied manipulation of data
is not applied or used in any other meaningful way beyond generally linking its use to a technological environment (computing unit)
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Paragraph [0094] as filed indicates “any form of computing device capable of interacting with the network 404, such as a desktop computer, workstation, terminal, portable computer, mobile device, smartphone, tablet, multimedia console, and/or the like.” – i.e., a generic or general-purpose computer.
The use of an “inhalation device” to determine a desired “trigger point” for delivery of an unspecified dose of an unspecified fluid is recited at a high level of generality with no specificity as to how a trigger point might be determined or how its determination relates to the performance of deep breathing, nor is there any relation between this nonspecific delivery of some fluid and the determination of the health information, particularly as there is no clear relationship as to when any of the assorted breaths take place. The Office’s 101 Example 43 addresses the specificity required in evaluation of recitation of generally delivering some nonspecific treatment, where the limitations as currently presented are the equivalent of merely adding the words “apply it”.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Claim Rejections - 35 USC § 103
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) 6, 11, 23-27, 29, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliveras (US 2017/0274163) in view of Steller (Microcontroller Based Diagnostic Smart Inhaler; Andrew Steller, University of Cincinnati, 7 December 2014; http://rave.ohiolink.edu/etdc/view?acc_num=ucin1445615167) and Weitzel (US 2014/0261414).
Regarding claim 6, Oliveras discloses a method for pulmonary health management for a user, the method comprising:
receiving a peak inspiratory flow measurement achieved during inhalation by the user on an inhalation device, the peak inspiratory flow measurement generated based on a minimum pressure of an air flow during the inhalation (paragraphs [0029], [0069]; PIF is based on the drop in pressure);
generating “pulmonary health management information” for the user using at least one computing unit communicatively coupled to the inhalation device (paragraphs [0023], [0024]), the pulmonary health management information including a “pulmonary health profile” generated based on the peak inspiratory flow measurement (paragraphs [0029], [0064]); and
outputting the pulmonary health management information to a graphical user interface for display (paragraph [0063], [0064]).
Oliveras further discloses receiving data related to exhalation (paragraphs [0035], [0036], [0048]), but does not specifically disclose also receiving a pulmonary output for the user, the pulmonary output determined by measuring a maximum flow achieved during an exhalation on the device, and including that output as part of the generation of the pulmonary health profile. Steller teaches a method of pulmonary health management comprising receiving a flow measurement achieved during inhalation by a user (section 4.3, see pp. 45-49), and receiving a pulmonary output for the user, the pulmonary output determined by measuring a maximum flow achieved during an exhalation (section 2.3; section 4.3); and generating pulmonary health management information for the user using at least one computing unit, the pulmonary health management information including a pulmonary health profile generated based on the inspiratory flow measurement and the pulmonary output (section 4.3, see for example figure 4.8 and its discussion on p. 47). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Oliveras and further included receiving and using a pulmonary output measured from flow during exhalation as part of generating the pulmonary health profile, as taught by Steller, because Oliveras already discloses monitoring pressure and flow during exhalation, as noted above, and Steller teaches that monitoring pulmonary output via maximum flow during exhalation provides useful information about a user’s condition that provides additional context to evaluation of the user.
Oliveras, as modified, does not disclose the inhalation device including a piezoelectric driver ejector or instructing the user to initialize the device by taking a set number of deep breaths on the device, determining from the deep breaths a trigger point during the inhalations of the initialization to actuate ejection of fluid from ejector to maximize inhalation of a dose of the fluid, and automatically dispensing a dose of the fluid and ejecting droplets from the ejector when the trigger point is reached during a “dosing inhalation” by the user.
Weitzel teaches a method of pulmonary health management comprising instructing a user of an inhalation device that includes a piezoelectric driven ejector to initialize the device by taking a set number of deep breaths on the device (paragraphs [0010]-[0012], [0263]), determining from the deep breaths a trigger point during the inhalations of the initialization deep breaths to generate breath actuated ejection of fluid from the ejector to maximize the user’s inhalation of a dose of the fluid (paragraph [0036], [0266]; avoiding triggering during exhalation maximizes the delivery relative to being undelivered), and automatically dispensing the dose of the fluid and ejecting droplets from the ejector when the trigger point is reached during a “dosing inhalation” by the user (paragraphs [0269]-[0281]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Oliveras, as modified, and included initialization of the inhalation device and use of the inhalation device to deliver a dose of fluid at a determined trigger point during inhalation, as taught by Weitzel, in order to treat a condition of the user. The Examiner notes that, as currently presented, the initialization of the device and the delivery of fluid during an inhalation have no relationship whatsoever to use of the device to obtain pulmonary measurements and evaluation of the pulmonary condition.
Regarding claim 11, Oliveras further discloses acquiring additional values of the flow measurements and using information derived from the additional values to track a change in the pulmonary health management information over time (paragraphs [0064]-[0067] – monitoring compliance, use frequency, etc.).
Regarding claim 23, Oliveras further discloses receiving the pulmonary health management information at a computer server from one or more inhalation devices communicatively coupled to the server (paragraphs [0064]-[0067]); receiving environmental data for one or more geographical locations in which the one or more inhalation devices are deployed, the environmental data captured using one or more environmental sensors and corresponding to an ambient air condition of each of the one or more geographical locations (paragraph [0060]); correlating the pulmonary health management information with the environmental data based on at least one management parameter using an air analyzer application running on the server (paragraph [0060], [0062]); and generating “air analytics” from the correlated data using the air analyzer application (paragraphs [0064]-[0067]). The Examiner notes that the claim does not require identifying the geographical location, only that the environmental data corresponding to an ambient air condition be obtained in that location.
Regarding claim 24, Oliveras further discloses outputting the air analytics for display on a user device (paragraph [0066]).
Regarding claim 25, Oliveras further discloses that the user device is at least one of a patient device or a provider device (paragraph [0066]).
Regarding claim 26, Oliveras further discloses that the at least one management parameter includes at least one of a disease type, a patient profile, a spray verification type, an environmental condition type, a device error type, or a pollutant type (paragraph [0060], barometric pressure is a type of environmental condition).
Regarding claim 27, Oliveras further discloses that the “air analytics” includes at least one of air quality analytics, disease analytics, healthcare analytics, device analytics, alerts, and trends (paragraphs [0064]-[0067], including alerts, trends of compliance, etc.).
Regarding claims 29 and 31, Oliveras further discloses receiving the pulmonary health management information at a computer server from one or more inhalation devices communicatively coupled to the server (paragraphs [0064]-[0067]); receiving environmental data for one or more geographical locations in which the one or more inhalation devices are deployed, the environmental data captured using one or more environmental sensors and corresponding to an ambient air condition of each of the one or more geographical locations (paragraph [0060]); correlating the pulmonary health management information with the environmental data based on at least one management parameter using an air analyzer application (paragraph [0060], [0062]); and generating air analytics from the correlated data using the air analyzer application (paragraphs [0064]-[0067]).
Claims 7 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliveras, as modified and applied above, and further in view of Shetty (US 2017/0270260).
Regarding claim 7, Oliveras, as modified, does not disclose the pulmonary health profile being further generated based on a concentration value of nitric oxide in the exhalation measured by a sensor of the device. Shetty teaches a method of pulmonary health management (paragraphs [0069]-[0070]) comprising sensing breath pressure and flow with a device (paragraph [0111], [0128]), and also detection of a concentration value of nitric oxide in in exhalation air flow with the device (paragraph [0126], [0128]), and which is configured to include the biomarker’s concentration in generation of the patient’s pulmonary health profile (paragraph [0128]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Oliveras, as modified above, and included measurement of a concentration of nitric oxide for the determination of the pulmonary health profile, as taught by Shetty, in order to provide additional insight into the patient’s condition.
Regarding claim 28, Oliveras further discloses receiving the pulmonary health management information at a computer server from one or more inhalation devices communicatively coupled to the server (paragraphs [0064]-[0067]); receiving environmental data for one or more geographical locations in which the one or more inhalation devices are deployed, the environmental data captured using one or more environmental sensors and corresponding to an ambient air condition of each of the one or more geographical locations (paragraph [0060]); correlating the pulmonary health management information with the environmental data based on at least one management parameter using an air analyzer application (paragraph [0060], [0062]); and generating air analytics from the correlated data using the air analyzer application (paragraphs [0064]-[0067]).
Claim(s) 9 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliveras, in view of Steller and Weitzel as applied above, and further in view of Fazzi (US 2014/0309546).
Regarding claim 9, Oliveras, as modified above, does not disclose the pulmonary health profile being further generated based on an airway resistance as measured with a sensor of the device.
Fazzi teaches a method of pulmonary health management comprising generating a pulmonary health profile (paragraph [0029], [0031]) based on an inspiratory flow measurement measured with a device (paragraph [0023], [0028]), an output determined from an exhalation measured with the device (paragraph [0023], [0043]), and an airway resistance measured with the device (paragraph [0028]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Oliveras, as modified above, and further included measurement of an airway resistance for generation of the pulmonary health profile, as taught by Fazzi, in order to include information about the patient’s physical condition.
Regarding claim 30, Oliveras further discloses receiving the pulmonary health management information at a computer server from one or more inhalation devices communicatively coupled to the server (paragraphs [0064]-[0067]); receiving environmental data for one or more geographical locations in which the one or more inhalation devices are deployed, the environmental data captured using one or more environmental sensors and corresponding to an ambient air condition of each of the one or more geographical locations (paragraph [0060]); correlating the pulmonary health management information with the environmental data based on at least one management parameter using an air analyzer application (paragraph [0060], [0062]); and generating air analytics from the correlated data using the air analyzer application (paragraphs [0064]-[0067]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliveras in view of Steller and Weitzel, as applied above, and further in view of Bitran (US 2017/0039344).
Regarding claim 12, Oliveras does not disclose the pulmonary health profile including at least one of a diagnosis of a pulmonary condition or a treatment for the pulmonary condition. Bitran teaches a method of pulmonary health management comprising generating a pulmonary health profile (paragraph [0032) from received breath measurements (paragraph [0019], [0031], [0038]), where the profile includes at least one of a diagnosis of a pulmonary condition or a treatment for the pulmonary condition (paragraph [0037]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Oliveras, as modified above, and included a diagnosis of a pulmonary condition or a treatment for the pulmonary condition in the pulmonary health profile, as taught by Bitran, in order to enable effective treatment and prevent adverse developments in the patient.
Response to Arguments
Applicant's arguments filed 8 September 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant merely asserts that all rejections have been overcome by the amendments; as the amendments have raised additional issues, this remark is moot.
Regarding the rejections under 101, Applicant generally asserts that the nonspecific delivery of a fluid which has no relationship to the identified abstract idea results in the abstract idea being more than a mental process; this is entirely unpersuasive, as addressed above.
Applicant’s arguments with respect to the art rejections of the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant addresses only the newly added limitations directed to delivery of a fluid, which are taught by Weitzel above.
The Examiner notes that Applicant’s remarks also do not address any of the teachings of Shetty, Fazzi, and Bitran, in addition to not addressing any of the teachings of Oliveras and Steller, beyond referring to the supposed deficiencies created by the newly added limitations; as these deficiencies are not present these remarks are moot.
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 KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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/KAREN E TOTH/ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791