DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Receipt is acknowledged of applicant's amendment filed on 6/23/26. Claims 1-28 and 30 are cancelled. Claim 29 is currently pending and an action on the merits is as follows.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 29 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps generate a first test instruction, calculate and FEV1 and generate a second test instruction based on a comparison.
The limitation of generate a first test instruction, calculate and FEV1 and generate a second test instruction based on a comparison., as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a control unit”; “a detection element” and a user feedback device, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the control unit, the detection unit and the display/interface, “generate” and “calculate” in the context of this claim encompasses the user generating some instructions to the patient verbally or visually and calculating the FEV1 from the sensor signal. If a claim limitation, 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. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of receive a first measurement signal from the detection unit. This detector involves mere data gathering and amounts to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, control unit and user feedback device are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components, i.e. a processor and display. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
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) 9, 19, 24 and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meng et al. US 2014/0316296 in view of Colman et al US 2010/0317986 further in view of Asanoi US 2012/0125337.
Regarding claim 29, Meng discloses a spirometry system comprising:
a detection element configured to generate measurement signals indicative of user-generated airflow ([¶56] spirometer);
a user feedback device comprising at least one of an audio and a visual feedback device ([¶74,76,81,86] display 16); and
a control unit communicatively connected to the detection element and the user feedback device ([¶73] microprocessor), wherein the control unit is configured to:
generate a first test instruction on the user feedback device for performing a breathing maneuver ([¶84,86] visual and audible instructions are given before testing),
receive a first measurement signal from the detection element indicative of user-generated airflow in response to the first test instruction ([¶47,51]),
calculate FEV1 based on the first measurement signal ([¶88,96]),
generate a user instruction to come off the mouth piece,
generate a plurality of post-test instructions for the user to review based on the first measurement signal, and
initiate a second test after the first test is complete, wherein the first test is completed on a first day and the second test is initiated on a second day subsequent to the first day ([¶84,86] instructions are provided for the testing regarding stop and start, three test are performed and post-test instructions are displayed including need and instructions for retesting. The retesting could be delayed or skipped for a day or longer in the same manner as Applicant’s device. Additionally, it would have been obvious to one of ordinary skill in the art at the time of filing to delay retesting for a day or more as is convenient for the user to have a successful test).
wherein the control unit is configured to generate at least one test result on the user feedback device on a test screen graphical user interface along a time axis subsequent to generating the first test instruction and prior to generating the second test instruction, the at least one test result comprising data from the first measurement signal; wherein the at least one test result corresponds to a flow rate measurement; wherein the flow rate measurement is presented over a plurality of seconds ([¶88] after a successful test graphs of the calculated parameters can be shown);
Meng discloses comparing data across tests and to historical testing data ([¶104]) but does not specifically disclose generate a second test instruction for repeating the breathing maneuver in response to determining at least one of: FEV1 is less than a first threshold standard deviation, the first threshold standard deviation based at least partially on a previous measurement signal received from the detection element, FEV1 is more than a second threshold standard deviation, the second threshold standard deviation based at least partially on a previous measurement signal received from the detection element, and the difference between FEV1 and a prior FEV1 value based on a previous measurement signal received from the detection element is above a pre-set threshold. Colman discloses using the standard deviation as a measure to determine if further testing is needed ([¶99,100]). It is noted that for claim 1, Meng discloses all elements if the FEV test does not meet the conditions for a repeat. Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to combine the device of Meng with the thresholds of Colman in order to determine consistency ([¶100-105]).
Meng as modified does not specifically disclose wherein the test screen graphical user interface is configured to display the time axis as an initial time interval and a plurality of subsequent time intervals, wherein the initial time interval is the first second, wherein the subsequent time intervals comprise a plurality of seconds after the first second, wherein the initial time interval is wider than each of the plurality of subsequent time intervals, wherein each of the plurality of subsequent time intervals are the same width, and wherein the user-generated airflow is graphed across the initial time interval and plurality of subsequent time intervals. Asanoi teaches a respiratory monitoring device that displays its flow waveform and expands the first second ([¶35,203-205] specific times can be enlarged if they need to be particularly observed and this can be entered or selected. This can be considered as pre-set as it is entered before the generation of the new graph display). Therefore, it would have been obvious to one of ordinary skill at the time of filing to combine the device of Meng with the teachings of Asanoi in order to enlarge time periods of interest ([¶254]).
Response to Arguments
Applicant's arguments filed 6/23/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Meng as modified by Colman and Assanoi does not specifically disclose “the test screen graphical user interface is configured to display the time axis as an initial time interval and a plurality of subsequent time intervals, wherein the initial time interval is the first second, wherein the subsequent time intervals comprise a plurality of seconds after the first second, wherein the initial time interval is wider than each of the plurality of subsequent time intervals, wherein each of the plurality of subsequent time intervals are the same width, and wherein the user-generated airflow is graphed across the initial time interval and plurality of subsequent time intervals”, Examiner respectfully disagrees. Assanoi teaches a display where a time segment can be expanding for further examination. So Assanoi is configured to display an enlarged region like the first second which is enlarged in comparison to its neighboring sections so it is wider than each of the plurality of time subsequent time intervals.
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 MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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