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 .
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.
Claim 1-4, 8-13, and 34-36 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 1 recites, “wherein the two holes open to an outer environment . . . ,” in line 10, but is indefinite. It is previously recited that at least one of the two holes are covered. How can the two holes be open to an outer environment and also have at least one or both holes covered? Would that not result in at least one or both holed bring restricted to an outer environment? Further clarification required.
Claims 2-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim. Claims 2-3 recite “a time of flight measurement performed within the scope of the pulmonary function test”, but is unclear what the scope of the pulmonary function test includes or excludes. Is the limitation referring to “a measurement of a time of flight of at least one signal by the airway extending between the two holes”? For examination purposes, it will be interpreted as such.
Claims not listed are rejected by virtue of claim dependency.
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, 8-13, and 34-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including correcting measurements corresponding to stored zero flow condition. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of correcting measurements one or more measurements based on the stored measurement corresponding to the zero flow condition sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The corrected measurement does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the correction, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of detecting a position of the pulmonary function test device, performing a measurement of a zero flow condition and storing the measurement. Detecting positions, performing measurements, and storing measurements are well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the detecting, performing, and storing steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ferencz et al. (US 20100095782), hereinafter Ferencz, further in view of Bajtala et al. (US 20210076980), hereinafter Bajtala.
Regarding claim 1, Ferencz teaches a method of determination of a zero flow level used for determining the zero flow level of a pulmonary function test device, comprising the following steps,
positioning the pulmonary function test device to cover at least one of the two holes of an airway of the pulmonary function test device (see figs. 13-16, the pulmonary function device (as indicated by “L”), is placed within the stand; the airflow is not in the direction of the sensors, but parallel to the sensors (see figs. 2-3 and 10, airflow is indicated by arrow),
wherein the pulmonary function test device comprises a stand having a base (see figs. 13-16, the pulmonary function device (L) is placed within a base (B1,B2;14)), and
sensors positioned to interact with the airway to provide a measurement of a time of flight of at least one signal by the airway extending between the two holes (see para. [0010,0051] and figs. 13-16, “transit time corresponding to a zero flow rate” indicating time of flight),
wherein the two holes open to an outer environment (see figs. 14 and 16, the holes of device L are open to outer environment prior to insertion), and
wherein the pulmonary function test device is positioned such that the at least one of the two holes are covered by the base of the stand (see fig. 13, both holes are covered by the base of the stand (within the interior walls of B1,B2); see fig. 15, one hole is uncovered, facing the environment; the other side is adjacent to the inner wall, i.e. covered, of the housing and considered the base),
Ferencz fails to teach detecting a position of the pulmonary function test device.
Bajtala teaches a spirometer comprising a position sensor to determine when the device is positioned horizontally and/or non-perpendicular positioning to aid in performing measurements under suitable conditions (see abstract and para. [0119]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ferencz, such that the position of the device is detected, as taught by Bajtala, to aid in performing measurements under suitable conditions.
It follows, Ferencz-Bajtala teach performing a measurement corresponding to zero flow condition by operating the sensors, storing the measurements corresponding to the zero flow condition (see para. [0010,0051], “a difference of said transit time and a transit time corresponding to a zero flow rate” indicating that values corresponding to the condition are stored for comparison),
correcting one or more measurements performed within a scope of a pulmonary function test based on the stored measurement corresponding to the zero flow condition (see para. [0051], “Each time a difference of the transit time values is detected under zero flow condition in a symmetrical arrangement, an offset value is determined and all subsequent measured values will be corrected on the basis of the offset value,” that is, the measurements are corrected based on zero flow condition measurements).
Regarding claim 2¸Ferencz teaches wherein the stored measurements corresponding to the zero flow condition is a zero flow time of flight and a corrected time of flight measurement is calculated after the zero flow time of flight is subtracted from a time of flight measurement performed within the scope of the pulmonary function test (see para. [0010,0051], “transit times t1 and t2 will also be equal to each other if the flow rate v.sub.a is zero. Therefore the difference of the two transit time values shall be zero (t2-t1=0)” indicating that measurements corresponding to zero flow conditions are based on zero time of flight of flow rate; “On the basis of a difference of said transit time and a transit time corresponding to a zero flow rate” and “A difference value on the basis of the determined first and second transit time values is generated and the flow parameters on the basis of said difference value is determined” indicating that a time of flight is calculated based on subtraction that will be used on to obtain an offset value, e.g., the corrected measurement).
Regarding claim 3, Ferencz teaches wherein a zero flow time of flight value calculated based on the stored measurements corresponding to the zero flow condition and a corrected time of flight measurement is calculated by subtracting the zero flow time of flight value from a time of flight measurement performed within the scope of the pulmonary function test (see para. [0011], “A flow rate value of the streaming medium can be determined on the basis of a difference value obtained from the reciprocal values of the transit times taken at the two transducers used as receivers” indicating that the flow rate is obtainable by subtracting ToF of a transit time corresponding to zero flow condition (correction value) and the ToF of incoming measurements).
Regarding claim 8, Ferencz teaches wherein the at least one of the airway is beared against a surface for positioning the pulmonary function test device to cover the at least one of the two holes of the airway (see figs. 15-16, one of the two holes is against the surface of 10,11, which partially cover one of the holes. The opposite side can also be considered the surface which entirely covers a hole; see fig. 13-14, the airway is abutted to the surface of B1 to aid in covering the holes).
Regarding claim 9, Ferencz teaches wherein the one of the two holes of the airway is seated to a floor (see fig. 16, the floor is considered comprising the platform located at 10,11 that hold the channel in place).
Regarding claim 10, Ferencz teaches wherein the at least one of the two holes of the airway is seated to the base of the stand, wherein the base has a specific slope on the stand (see fig. 13-14, B1,B2 comprise a base (inner wall) with a specific slope, e.g., curves, and the stand is considered the external portions of B1,B2; Additionally, the corners of the holes of the device (L) are seated to the base).
Ferencz fails to teach wherein the method comprises detecting, by at least one orientation sensor of the pulmonary function test device, an orientation of the pulmonary function test device for the determination of the zero flow level.
Bajtala teaches a spirometer comprising a position/orientation sensor to determine when the device is positioned horizontally and/or non-perpendicular positioning to aid in performing measurements under suitable conditions (see abstract and para. [0102,0119], gyroscope and accelerometer are incorporated to determine movement and position/orientation when determining zero flow conditions). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ferencz, such that detection of orientation of the device is performed, as taught by Bajtala, to aid in performing measurements under suitable conditions and for alerting the user to correct their positioning for improved analysis of lung function (see para. [0119] of Bajtala).
Claims 4 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Ferencz further in view of Bajtala, as applied to claims 1 and 8, further in view of Schuelke et al. (US 20170273597), hereinafter Schuelke.
Regarding claim 4, Ferencz-Bajtala fail to teach using the pulmonary function test device wherein a mouthpiece coinciding with the airway is attached to the pulmonary function test device.
Schuelke teaches a pulmonary function device comprises a mouthpiece 135 coinciding with the airway channel 130 (see abstract).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ferencz-Bajtala, such that the pulmonary function device comprises a mouthpiece coinciding with the airway, as taught by Schuelke, as it would merely be using a known technique (using mouthpiece coinciding with airway) to improve similar methods (using pulmonary functioning tests) in the same way.
Regarding claim 34, Ferencz-Bajtala teach seating the at least one of the two holes of the airway to a base (see figs. 13-16 of Ferencz) and an orientation sensor for of electrical contacts or switches positioned on the pulmonary function device (see para. [0119] of Bajtala, comprises accelerometer and gyroscope). Ferencz-Bajtala fail to teach wherein the stand comprises an orientation sensor.
Schuelke teaches a pulmonary function device 130 and stand 105 wherein the device and stand comprise an orientation sensor, e.g., accelerometer, gyroscope, to detect axial changes (see abstract and para. [0003,0149]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ferencz-Bajtala, such that the stand comprises and orientation sensor, as taught by Schuelke, to aid in detecting axial changes and allow the individual to interact with a visual display (see para. [0148]). Furthermore, the modification is merely applying a known technique (orientation sensor on stand) to improve similar devices (lung function devices) in the same way.
Regarding claim 35, Ferencz-Bajtala fail to teach wherein the pulmonary function test device includes at least one sensor formed as a magnet, a hall effect sensor, or a proximity sensor, the method comprising: deducing, by the at least one sensor, whether the pulmonary function test device is seated in a seat of the stand.
Schuelke teaches a pulmonary function device 130 and stand 105 wherein the device and stand comprise a proximity sensor for sensing a detachable element 105 (see para. [0074,0080-84], “A spirometer can comprise a sensor, e.g., a proximity sensor to sense a detachable element”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ferencz-Bajtala, such that a proximity sensor is included in the device and configured to sense/deduce the position of the device relative to the stand thereby when it is contact, as taught by Schuelke, as it would merely be applying a known technique (proximity sensor to determine when the device is seated/positioned relative to a stand) to improve similar devices (lung function devices) in the same way.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ferencz further in view of Bajtala, as applied to claim 1, further in view of Yorke et al. (US 20190150849), hereinafter Yorke.
Regarding claim 11, Ferencz-Bajtala fail to teach wherein a notification for positioning the pulmonary function test device to cover the at least one of the opening of the airway is sent to a user to determine the zero flow level.
It is noted that Ferencz requires positioning the pulmonary function device to cover at least one hole in figs. 13-16.
Yorke teaches a smart pulmonary function test device comprising a validity indicator that notifies a user when there is an error, i.e., hardware error, and to fix the error. One skilled in the art understands that Ferencz requires the device to be attached to their respective base, thereby a hardware error when not attached.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ferencz-Bajtala, such that a notification for hardware error (positioning the pulmonary function device to cover one of the opening of the airway) is sent to a user, as taught by Yorke, to prevent errors with data (see para. [0052] of Yoke). Additionally, the modification is merely using a known technique (notifying hardware errors) according to known methods (lung function tests) in the same way.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ferencz further in view of Bajtala and Yorke, as applied to claim 11, further in view of Higgins et al. (US 20180344209), hereinafter Higgins.
Regarding claim 12, Ferencz-Bajtala-Yorke fail to teach wherein the notification is delivered to the user when a predefined period has passed after a determination of a last stored zero-flow level.
Higgins teaches a pulmonary function device test a method for calibrating the device based on detecting and notifying when the device has not been calibrated within a predetermined period (see abstract and para. [0124]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ferencz-Bajtala-Yorke, such that a notification is delivered to a user when a period has passed after calibration (last stored zero flow level), as taught by Yorke, because Ferencz requires calibration, but fails to provide details, and Yorke teaches it can be performed after a predetermined time since the last calibration.
Regarding claim 13, Ferencz-Bajtala-Yorke fail to teach wherein the notification is delivered to the user when a predefined number of the pulmonary function tests have been performed after a determination of a last stored zero flow level.
Higgins teaches that a lung function test device can comprise a notification to the user when there is no valid verification or expired calibration prior to a test (see para. [0127]).
Ferencz teaches that a valid calibration is required before each test (see para. [0051]), and understood to be a predefined number of a pulmonary function test after a determination of a last stored zero flow level.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Ferencz-Bajtala-Yorke, such that a notification is delivered to a user when the calibration has expired, as taught by Higgins, as it would merely be combining prior art elements (calibrating spirometers when a predefined number of a test has been performed ) according to known methods (notification that calibration is required) to yield predictable results (notification that calibration is required after a predefined number of a test).
Response to Arguments
Applicant's arguments filed 06/27/2025 have been fully considered but they are not fully persuasive.
Applicant argues that Ferencz fails to disclose or suggest any such positioning of the pulmonary function test device or that the pulmonary function test device comprises a stand having a base, on pages 8-10 of the Remarks. The examiner disagrees. Applicant further reasons that the housings in figs. 13-14 are not capable of covering holes of the airway conduit L nor do the sensors cover the holes.
Both housings in figs. 13-16 do in fact cover the conduit. Figs. 13-14 show that the airway L is inserted within the housing, this inherently requires that the airway be covered.
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See fig. 13 of Ferencz. The direction of the airflow is indicated with the green arrow. Moreover, we see in this state how the base, i.e. surfaces of the inner wall, wholly covers the conduit.
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See fig. 15 of Ferencz. The direction of the airflow is indicated with the green arrow. Moreover, we see in this state how the base, i.e. surface of the inner wall, covers the hole in the direction of the airflow.
It cannot be said that that the disclosure of Ferencz lacks covering at least one hole because it is clear in both instances that both holes are covered as seen in fig. 13 or one hole is covered as seen in fig. 15. It appears that Applicant mistakenly associated the holes to be located where the sensors are positioned, however, that is not the case.
Additionally, the “housings,” as described by Applicant, in fig. 13 and 15 that hold the conduit, do in face have a base and a stand. A base is a support, usually at the bottom to support an object. In this case, we have a base on both fig. 13 and fig. 15 because the conduit is supported by the lower most surface wholly (fig. 15) or at specific locations (fig. 13) relative to the holding location, e.g., cavity (see figs. 14 and 16). Therefore, the housing is the stand that supports the base and conduit. This is similar to the present invention.
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See fig. 6. Applicant associates element 6 as the base and the stand is 8. Both the stand and base are associated to one “housing.”
Therefore, Applicant arguments are found unpersuasive.
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN NATHAN ORTEGA/ Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791