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
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(a-d) with reference to Application Number: DE102020007180.5 filed on 11/24/2020
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “premature expiration trigger”, which is not labeled in Figure. 7, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Claims 67-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/15/2026.
Applicant’s election of Group I in the reply filed on 05/15/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 preparation unit”, “a calculation unit”, “a detection unit”, “a storage unit”, “a monitoring unit”, and “a control unit” in claim 50.
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 Objections
Claim 50 is objected to because of the following informalities: the limitation “is configured to at least partially and least temporarily” should read “is configured to at least partially and at least temporarily” (emphasis added). 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.
Claim 62 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 62 recites “wherein the leakage flows of greater than a threshold flow of from 15l/min to 50 l/min”, which is a range within a range. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 50 and 51 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tams (US 20160325061).
50. Tams discloses a system for detecting asynchronies between a ventilator and a living being [0020], wherein the system comprises at least one ventilator which comprises at least - a sensor unit (142, see [0021]) - a preparation unit (112, [0033 – 0037]) - a calculation unit (113, [0038 – 0042]), - a detection unit (114, [0043 – 0045]), - a storage unit (130, [0023, 27, 28]), - a monitoring unit (120, which monitors and displays the operational state of the ventilator per [0025]), - a control unit (115, [0046 – 0047]), and - a fan/valve unit (140, [0023]); and wherein the detection unit is configured to detect asynchronies between the ventilator and the living being based on respiratory parameters of the living being [0043], and the control unit is configured to at least partially and least temporarily automatically control the ventilator based on the asynchronies detected by the detection unit [0046], wherein the detection unit detects missed breaths and/or short trigger delays and/or incorrect triggerings and/or premature expiration triggers and evaluates same as asynchronies [0020].
51. Tams discloses the system of claim 50, wherein the detection unit detects missed breaths and/or short trigger delays and/or incorrect triggerings and/or premature expiration triggers and evaluates same as asynchronies [0020].
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) 52, 53, and 55 – 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tams in view of Mulqueeny (US 20130152934).
52. Tams discloses the system of claim 51 and furthermore discloses that wherein the detection unit detects asynchrony based on any measurement, determination, and/or estimation. However, Tams does not disclose detection of the missed breaths and/or the short trigger delays by evaluating a respiratory exertion, an expected respiratory flow, and a determined respiratory flow. Nonetheless, Mulqueeny discloses a ventilator for synchronizing its treatment with the living being [0009] with detection of missed breaths and/or the short trigger delays by evaluating a respiratory exertion, an expected respiratory flow, and a determined respiratory flow (see Figs. 4 – 9, [0116], the determined respirator flow corresponding to the measured total flow 400, the expected respiratory flow corresponding to expected apparatus flow 500, and the respiratory exertion flow corresponding to the muscular exertion flow 600; see [0145], [0133], for determination/calculation of the expected respiratory flow and respiratory exertion flow; detection of the missed breaths and/or short trigger delays based on the respiratory exertion flow is illustrated in Fig. 9, [0145], trigger delay 804-1 is detected compared against 804-2; lastly note para [0146] denoted as expiratory trigger for missed breathing during the ventilator provided pressure support). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the asynchrony determination of Tams according to respiratory exertion flow as taught in Mulqueeny for the benefit of non-invasively and accurately detecting/controlling synchrony between the ventilator and living being, see [0049].
53. Tams as modified discloses the system of claim 52, wherein the calculation unit determines the respiratory exertion flow from the expected respiratory flow and the determined respiratory flow (see Mulqueeny, [0145]).
55. Tams as modified discloses the system of claim 52, wherein the calculation unit determines an expected respiratory flow from an airway resistance R and a lung elasticity E (see Mulqueeny, [0136], [0133], where elasticity is the inverse of compliance as disclosed).
56. Tams as modified discloses the system of claim 55, wherein the calculation unit calculates the airway resistance R and the lung elasticity E from measured values measured by the sensor unit and prepared by the preparation unit (see Mulqueeny, [0136]).
57. Tams as modified discloses the system of claim 55, wherein the airway resistance R and the lung elasticity E are determined by the calculation unit via a mathematical lung model (see Mulqueeny, [0179]).
58. Tams as modified discloses the system of claim 55, wherein the airway resistance R and the lung elasticity E are determined by the calculation unit via a multiple linear regression and a one-compartment lung model (see Mulqueeny, [0177 – 0179]).
Claim(s) 59 - 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tams in view of Zheng (US 20140283833).
59. Tams discloses the system of claim 51, but does not disclose wherein the control unit automatically sets a trigger sensitivity of the ventilator based on the missed breaths and short trigger delays detected by the detection unit. Zheng discloses wherein the control unit automatically sets a trigger sensitivity of the ventilator based on the missed breaths and short trigger delays detected by the detection unit (see [0040], [0038]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the control unit of Tams according to the automated trigger sensitivity of Zheng for the benefit of automating the trigger sensitivity in a manner that finds its goldilocks position so as to reduce both ineffective and false triggers.
60. Tams as modified discloses the system of claim 59, wherein the control unit further automatically sets the trigger sensitivity of the ventilator based on incorrect triggerings detected by the detection unit (see Zheng, [0040]).
61. Tams as modified discloses the system of claim 59, wherein the control unit automatically adapts the trigger sensitivity in accordance with a number of detected short trigger delays and missed breaths within a predetermined time interval (see Zheng [0040], [0038], Fig. 2). However, Zheng does not explicitly disclose a time interval of from 0.5 minutes to 5 minutes. However, Zheng discloses that the predetermined time interval or sliding window is an adjustable personal preference which is understood to optimize responsiveness versus accuracy of the trigger level. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the time interval of Zheng within applicant’s claimed range of 0.5 minutes to 5 minutes for the benefit of adjustable personal preference which is understood to optimize responsiveness versus accuracy of the trigger level. It has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Claim(s) 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tams in view of Zheng in view of Jafari (US 20020053345) in view of Liu (CN 109222978).
62. Tams in view of Zheng discloses the system of claim 59, but does not disclose wherein with leakage flows of greater than a threshold flow of from 15 l/min to 50 l/min, the trigger sensitivity is set in the form of an average trigger sensitivity, which is determined with incorporation of trigger sensitivities from prior periods of time having leakage flows below the threshold flow. Jafari discloses wherein with leakage flows of greater than a threshold flow of from 15 l/min to 50 l/min, the trigger sensitivity is set in the form of a different trigger sensitivity, see [0075, 0077]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the trigger sensitivity of Zheng conditional on leakage as taught in Jafari for the benefit of ensuring that a high leak state with impacts on the trigger sensitivity does not concurrently impact the automation.
However, Jafari does not disclose an average trigger sensitivity, which is determined with incorporation of trigger sensitivities from prior periods of time having leakage flows below the threshold flow. However, Liu discloses an average trigger sensitivity, which is determined with incorporation of trigger sensitivities or values from prior periods of time (see page 4 para 9 of the provided translation). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the leakage conditional trigger sensitivity of Zheng in view of Jafari according to the average trigger sensitivity of Liu for the benefit of appropriately fitting the trigger sensitivity of the patient, especially under high leak situations. Upon providing the modification as described, the combined references render obvious incorporation of trigger sensitivities from prior periods of time having leakage flows below the threshold flow.
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tams in view of Zheng in view of Acker (US 20070028920).
63. Tams discloses the system of claim 59, but does not disclose wherein the trigger sensitivity can be set manually and automatically, an automatic setting being able to set lower threshold values of parameters for triggering as is possible by a manual setting. Acker discloses wherein the trigger sensitivity can be set manually and automatically, an automatic setting being able to set lower threshold values of parameters for triggering as is possible by a manual setting (see [0026], the finer increments can be set at each breath which is a finer level of adjustment allowing for repetition at each breath, thereby allowing lower values for triggering than otherwise possible via a manual setting maintained throughout). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the trigger sensitivity of Zheng according to the manual setting as taught in Acker for the benefit of allowing for manual capability while maintaining benefits such as finer/lower increments inherent to continuously calculated automation.
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tams in view of Zheng in view of Li (US 20190344034).
64. Tams discloses the system of claim 59, but does not disclose wherein the trigger sensitivity comprises a value which controls switching from an inspiration phase to an expiration phase, the ventilator being configured and designed to set the value of the trigger sensitivity that controls the switching from an inspiration phase to an expiration phase based on detected premature expiration triggers. Li discloses wherein the trigger sensitivity comprises a value which controls switching from an inspiration phase to an expiration phase, the ventilator being configured and designed to set the value of the trigger sensitivity that controls the switching from an inspiration phase to an expiration phase based on detected premature expiration triggers [0089]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify Zheng according to the exhalation trigger of Li for the benefit of providing appropriate triggering sensitivity at patient exhalation.
Claim(s) 65-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tams in view of Angelico (US 20140034054).
65. Tams discloses the system of claim 51, but does not disclose wherein a trigger delay is detected as a short trigger delay if the trigger delay is less than or equal to a threshold value, the threshold value being in a range of from 0 seconds to 0.5 seconds. Angelico discloses a trigger delay is detected as a short trigger delay if the trigger delay is less than or equal to a threshold value, the threshold value being in a range of from 0 seconds to 0.5 seconds (see [0111], wherein Angelico parses short or adequate trigger delays from other trigger delays labeled, which are then labeled as missed breaths). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the system of Tams according to the trigger delay of Angelico for the benefit of calculating the trigger delays to monitor and classify appropriate synchronization of the ventilator and living being in patients such as pediatric patients.
66. Tams as modified discloses the system of claim 65, wherein the detection unit detects and determines the trigger delay via an offset between a respiratory exertion of the living being and a triggering of the ventilator (see Angelico, [0111]).
Allowable Subject Matter
Claim 54 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Tams in view of Mulqueeny fails to disclose wherein the detection unit detects the missed breaths based on at least one of the following features of a respiratory exertion flow, an expected respiratory flow and/or a determined respiratory flow: a local maximum of the determined respiratory flow lies between two minima of the respiratory exertion flow: difference between a temporal position of a local maximus of the respiratory exertion flow and a corresponding left minimum: difference between a temporal position of a local maximum of the respiratory exertion flow and a corresponding right, minimum; difference between values of a local maximum of the respiratory exertion flow and a corresponding left minimum; difference between values of a local maximum of the respiratory exertion flow and a corresponding right minimum; expected respiratory flow at a point in time of a local maximum of the respiratory exertion flow; time between a local maximum of the respiratory exertion flow and expected trigger point in time. If furthermore would not have been obvious to one of ordinary skill in the art to modify Tams in view of Mulqueeny to include such feature without the benefit of hindsight reasoning. As such, claim 54 patentably defines over the closest prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Truschel - US 20130269697 – disclosing a sensor flow and patient effort flow
Mulqueeny - US 20130269697 – Figs. 14 – 16 discloses sensor flow against model
Liu - US 20140053840 A1 – adjustment of trigger sensitivity
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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