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 2/18/25. Claims 5-8 and 15-18 are cancelled. Claims 21-30 are new. Claims 1-4, 9-14 and 19-30 are 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.
Claims 1-4, 9-14 and 19-30 are 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. 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 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.
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: a detection element and a control unit in claims 1, 11 and 29.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 29-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. It does not appear that the specification supports that the time axis expansion is preset. ¶34 is the only description of expanding the 0-1 second time frame and merely states that the graph may be expanded but there is no indication as to whether this is preset or selected.
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) 1-4, 10-14 and 20-28 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.
Regarding claims 1 and 11, 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 ([¶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)
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]).
Regarding claims 2 and 12, Colman does not disclose the controller is configured to determine whether FEV1 is less than mean FEV1 - 1.68 x SD when determining FEV1 is less than a first threshold standard deviation. Colman does disclose using the standard deviation and difference thresholds to determine if retesting is needed ([¶100-105]). Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Colman to include the specific threshold since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 3 and 13, Colman does not specifically disclose the controller is configured to determine whether FEV1 is more than mean FEV1 + 2.45 x SD when determining FEV1 is more than a second threshold standard deviation. Colman does disclose using the standard deviation and difference thresholds to determine if retesting is needed ([¶100-105]). Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Colman to include the specific threshold since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 4 and 14, Colman does not disclose wherein the controller is configured to determine whether the difference between FEV1 and the prior FEV1 value is greater than 0.15 L when determining the difference between FEV1 and a prior FEV1 value is above a pre-set threshold. Colman does disclose using the standard deviation and difference thresholds to determine if retesting is needed ([¶100-105]). Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Colman to include the specific threshold since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 10 and 20, Meng discloses the detection element is a transducer ([¶6,53]).
Regarding claims 21, 22, 25 and 26, Colman does not disclose the controller is configured to determine whether FEV1 is less than mean FEV1 - 1.64 x SD when determining FEV1 is less than a first threshold standard deviation. Colman does disclose using the standard deviation and difference thresholds to determine if retesting is needed ([¶100-105]). Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Colman to include the specific threshold since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 23 and 27, Colman does not disclose the controller is configured to determine whether FEV1 is less than mean FEV1 + 1.96 x SD when determining FEV1 is less than a first threshold standard deviation. Colman does disclose using the standard deviation and difference thresholds to determine if retesting is needed ([¶100-105]). Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Colman to include the specific threshold since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
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 claims 9, 19, 24 and 28, Meng as modified by Asanoi does not specifically disclose the 120ms, 250ms and 300ms mark. However at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to expand the one second time window because Applicant has not disclosed that 1 second window or the 120ms mark provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the selected time period enlargement of Asanoi because it allows the user to enlarge whichever time period is necessary. Therefore, it would have been an obvious matter of design choice to modify Meng in view of Asanoi to obtain the invention as specified in claims.
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 ([¶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)
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 preset with the time axis configured to present an initial time interval as expanded to display additional time increments along a first length of the time axis, and a plurality subsequent time intervals after the initial time interval are presented at the same time as unexpanded with each of the plurality subsequent time intervals after the initial time interval having a preset second length short than the first length. Asanoi teaches a respiratory monitoring device that displays its flow waveform and expands the first second ([¶35,203-205] specific times can be enlarged to 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]).
Regarding claim 30, Asanoi teaches wherein the initial time is the first second and the plurality subsequent times is a plurality of seconds after the first second ([¶35,203-205] specific times can be enlarged to if they need to be particularly observed and this can be entered or selected).
Response to Arguments
Applicant's arguments filed 2/18/25 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 101 rejection, Examiner respectfully disagrees. The claims only recite the additional structure of a spirometer, a control unit and feedback device. The spirometer is a generic sensor that is not integral to the abstract idea. It merely performs pre-solutional data gathering. The control unit is a generic computer element, specifically a processor which does not add significantly more as the abstract idea is just implemented on it. The feedback device is just a display or output device, generically recited, and only performs the post-solutional activity of presenting the determination. It is has not been shown that the device is a particular machine or used for a particular application.
Regarding Applicant’s arguments against Meng in view of Colman, Examiner respectfully disagrees. Colman is relied upon to teach using the standard deviation as an indication of whether retesting is needed or correction/adjustment is needed. Meng discloses the testing device that determines spirometric measures and comparing testing data to previous tests or patient historical data. The fact that Colman performs its SD determinations on previous breath cycles as opposed to test data or historical data is not pertinent since Meng already discloses these aspects and the standard deviation determinations and thresholding of Colman is equally as useable with the device of Meng.
Regarding Applicant’s argument that Asanoi does not teach the new claimed subject matter, Examiner respectfully disagrees. The claim language is not specific enough to overcome the teachings of Asanoi. Specifically, based on Applicant’s specification, it is not clear that the expanded first second is preset or if the expansion of the first second is some sort of default for the display. It merely states that the first second can be expanded so the teachings of Asanoi of selecting the time window or inputting a time range to expand still reads on the claim language. To overcome Asanoi the claim would need to make clear that the expansion is some sort of default or standard operation and not input by a user like in Asanoi.
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 W CHEN/Supervisory Patent Examiner, Art Unit 3791