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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on October 22, 2025 has been entered.
Priority
Acknowledgement is made to Applicant’s claim to priority to PCT EP2017/052004 filed January 31, 2017, to Foreign Application No. DE10201609528 filed May 24, 2016, and to Foreign Application No. DE102016103678 filed March 1, 2016.
Status of Claims
This Office Action is responsive to the amendment filed on October 22, 2025 after Patent Board Decision where the Examiner was affirmed August 27, 2025. As directed by the amendment: claims 1, 9, 11, 13, and 22 have been amended; and claims 10 and 24 have been cancelled. Thus, claims 1-9 and 11-23 are presently pending in this application.
Claims 9-11 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ernst et al. (U.S. Pat. No. 3,9,72,327). Claim(s) 1-8, 13-20, 22, and 24 were previously rejected under 35 U.S.C. 103 as being unpatentable over Ernst et al. (U.S. Pat. No. 3,9,72,327) in view of Nord (U.S. Pat. No. 5,915,381). Claim(s) 12 was previously rejected under 35 U.S.C. 103 as being unpatentable further in view of further view of Martin (U.S. PG Pub. 2010/0108066). Claim 21 was previously rejected under 35 U.S.C. 103 as being unpatentable further view of Devires (U.S. Pat. 5,915,381) and Wondka (U.S. Pat. 8,770,193). Claim 23 was previously rejected under 35 U.S.C. 103 as being unpatentable further view of Martin (U.S. PG Pub. 2010/0108066).
Applicant’s arguments were not persuasive and the previous grounds of rejection have been maintained, shown below.
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) 1-8, 13-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ernst et al. (U.S. Pat. No. 3,9,72,327; hereinafter: “Ernst”) in view of Nord (U.S. Pat. No. 5,915,381) in view of Gropper et al. (U.S. Pat. No. 5,540,220; hereinafter: “Gropper”).
Regarding Claims 1, 13, and 22, Ernst discloses a ventilation device for ventilating a patient (Abstract), the ventilation device comprising a fluid supply unit (2, 3, 4; Fig. 1, 7) and, additionally, a fluid discharge unit (5, 7, 8; Fig. 1, 7), which are suitable for supplying a fluid into at least one airway of a patient (11; Fig. 1, 7; col 2, ln 38-55; col 4, ln 4-18) and for discharging the fluid from this airway (col 4, ln 19-47; col 5, ln 62 to col 6, ln 31); and a control device (13; Fig. 1, 7) which controls a ventilation of the at least one airway (col 2, ln 56 to col 3, ln 3), and wherein at all times during the ventilation the fluid supply rate and fluid discharge rate are controlled and determined alone by the ventilation device and not by the patient, so that exhalation does not take place passively with the energy stored in the elastic tissue elements of lung and thorax driving the exhalation (col 1, ln 8-15; col 2, ln 20-55; col 4, ln 4-47; Examiner notes: Ernst discloses the ventilation device in which flow and pressure of the respiration gas are automatically regulated during inspiration and expiration and wherein the ventilation device replaces the respiratory function in patients. As such, the at all times the control device is controlling the ventilation, and exhalation is not triggered by the patient and occurs by the active application of negative pressure.).
Ernst does not specifically disclose the ventilation device wherein the control device which, during a ventilation of the at least one airway, is suitable for determining or in addition for estimating a profile of at least one subregion of a compliance curve of the at least one airway by the supply and/or discharge of the fluid from the at least one airway and by determination of at least one value of the compliance curve; wherein the following applies for the compliance C:
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wherein the compliance indicates how much fluid in a volume V [milliliter] is introduced into the at least one airway or is removed from the airway, such that a pressure in the airway changes by a pressure difference delta p [millibar]; wherein the control device, taking into account the determined or additionally estimated profile of the at least one subregion of the compliance curve, determines a position of a pressure interval with the pressures P1 and P2 and sets the ventilation device such that at least one ventilation process in the form of an inhalation and an exhalation takes place between these pressures P1 and P2 and an absolute value of the compliance of this ventilation process is as high as possible; wherein the control device is configured to regulate at least one ventilation process such that there is the fluid supply rate [milliliter/second] is substantially constant during an entirety of the inhalation or there is the fluid discharge rate [milliliter/second] is substantially constant during an entirety of the exhalation.
Nord teaches the ventilation device for ventilating a patient [col. 1 lines 58-59 discloses a breathing apparatus; Fig. 1 breathing apparatus (2; Fig. 1)], the ventilation device comprising a fluid supply unit (10; Fig. 1), additionally, a fluid discharge unit (20; Fig. 1), which is suitable for supplying a fluid into at least one airway of a patient and for discharging the fluid from this airway [col. 2 Lines 48-67 disclose inspiratory valve (10) supplying fluid and expiratory valve (20) discharging fluid; Fig 1]; and a control device (12; Fig. 1) which, during a ventilation of the at least one airway, is suitable for determining or in addition for estimating a profile of at least one sub-region of a compliance curve of the at least one airway by the supply from the at least one airway and by determination of at least one value of the compliance curve (col. 3 Lines 50-60; Fig. 2 and Fig. 3 show a volume vs. Pressure curve with sub-region 36A 36B 36C and a compliance vs. Time curve with sub-region 40A and 40B); wherein the following applies for the compliance C:
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wherein the compliance indicates how much fluid in a volume V [milliliter] is introduced into the at least one airway, such that a pressure in the airway changes by a pressure difference delta ppressures P1 and P2 and an absolute value of the compliance of this ventilation process is as high as possible (col. 3 Lines 52-67; col. 4 lines 10-14; Examiner notes: Nord discloses a compliance cure being constantly high; col. 4 lines 26-34) for the purpose of improving the health of the patients lungs by increasing the compliance of the lungs of the patient (col 2, ln 5-14; col 4, ln 15-23).
Gropper teaches a mechanical ventilator comprising a control device (56; Fig. 4; col 8, ln 4-27) is configured to regulate at least one ventilation process such that there is the fluid supply rate [milliliter/second] is substantially constant during an entirety of the inhalation (Fig. 2; col 4, ln 64 to col 5, ln 21; col 8, ln 57 to col 9, ln 8) for the purpose of delivering the fluid using a square waveform such that the proximal pressure increases approximately linearly throughout the inspiratory phase to a peak inspiratory pressure (col 5, ln 3-16).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the ventilation device of Ernst to include controlling the ventilation based on compliance C, wherein C=V/(Δp), as recited above, as taught by Nord and include the control device is configured to regulate at least one ventilation process such that there is the fluid supply rate [milliliter/second] is substantially constant during an entirety of the inhalation as taught by Gropper for the purpose of improving the health of the patients lungs by increasing the compliance of the lungs of the patient (See Nord: col 2, ln 5-14; col 4, ln 15-23) and delivering the fluid using a square waveform such that the proximal pressure increases approximately linearly throughout the inspiratory phase to a peak inspiratory pressure (See Gropper: col 5, ln 3-16), respectively.
Regarding claims 2 and 14, the modified device of Ernst further discloses the control device, at least during an inhalation of a ventilation process, determines a plurality of values for the compliance and from the plurality of values for compliance determines, for at least one subsequent ventilation process, the position of the pressure interval with the pressures P1 and P2, for which an absolute value of the compliance is as high as possible (See Nord: col. 3 lines 43-67; col. 4 Lines 1-33 discloses a compliance cure being constantly high).
Regarding claims 3 and 15, the modified device of Ernst further discloses the control device continuously determines values for the compliance, such that the position of the pressure interval with the pressures P1 and P2 can be newly determined optionally for each subsequent ventilation process or for a plurality of successive ventilation processes (See Nord: col. 3 lines 43-67; col. 4 lines 1-33).
Regarding claims 4 and 16, the modified device of Ernst further discloses the control device, as a function of the determined position of the pressure interval, of the pressure interval itself and of the determined compliance, determines at least for the subsequent ventilation process at least one of the following parameters: a pressure P1 and pressure P2 (See Nord: col. 3 lines 43-67; col. 4 lines 1-33).
Regarding claims 5 and 17, the modified device of Ernst further discloses a pressure sensor is arranged inside the at least one airway, and the pressure is determined by a measurement inside the at least one airway (See Ernst: 9, 105’; Fig. 1, 7; col 12, ln 4-6, See Nord: col. 3 lines 4-20; Fig. 1; pressure meter 24).
Regarding claims 6 and 18, the modified device of Ernst further discloses at least one pressure rise during an inhalation is controlled and limited by the ventilation device (See Ernst: col 2, ln 38-55; col 4, ln 4-18; Fig. 9, See Nord: col. 2 lines 26-33; col. 3 Lines 52-67; col. 4 Lines 1-14).
Regarding claims 7 and 19, the modified device of Ernst further discloses at least one pressure drop during an exhalation is controlled and limited by the ventilation device (See Ernst: col 4, ln 19-47; col 5, ln 62 to col 6, ln 31; Fig. 9, See Nord: col. 2 lines 26-33; col. 3 Lines 52-67; col. 4 Lines 1-14).
Regarding claims 8 and 20, the modified device of Ernst does not disclose the absolute value of the pressure rise is limited to at most 40 mbar/s [millibar/second].
It would have been obvious as to one of ordinary skill in tire art before the effective filing date of the claimed invention to modify the ventilation device of Ernst to the absolute value of the pressure rise to be limited to at most 40 mbar/s. Applicant places no criticality on one particular pressure rise value (Par. [0032] of applicant’s specification). Modifying the modified device of Ernst to have the claimed range would not have adverse effects on the performance of the device and thus the changing the range would not destroy the device. The courts have held that, “where the only difference between the prior art and the claims was a recitation of relative ranges of the claimed device and a device having the claimed relative ranges would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. In Gardner v. TEC Syst. Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cm. 1984), cert, denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claim(s) 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ernst (U.S. Pat. No. 3,9,72,327) in view of Gropper (U.S. Pat. No. 5,540,220).
Regarding claim 9, Ernst discloses a ventilation device for ventilating a patient (Abstract), the ventilation device comprising a fluid supply unit (2, 3, 4; Fig. 1, 7) and, additionally, a fluid discharge unit (5, 7, 8; Fig. 1, 7), which is suitable for supplying a fluid into at least one airway of a patient (11; Fig. 1, 7; col 2, ln 38-55; col 4, ln 4-18) and for discharging the fluid from this airway (col 4, ln 19-47; col 5, ln 62 to col 6, ln 31); and a control device (13; Fig. 1, 7) which, during a ventilation of the at least one airway, in which the fluid is supplied into the at least one airway (col 2, ln 38-55; col 4, ln 4-18) and the fluid is discharged from the at least one airway by operation of the ventilation device (col 4, ln 19-47; col 5, ln 62 to col 6, ln 31), is suitable for regulating the ventilation (col 1, ln 8-15; col 2, ln 20-55; col 4, ln 4-47; col 5, ln 62 to col 6, ln 31); wherein the control device regulates at least one ventilation process such that a pressure in the at least one airway is continuously changed at least during an entire exhalation (col 4, ln 19-47; col 5, ln 62 to col 6, ln 31; Fig. 9), by continuous control of a fluid discharge rate during the ventilation process (col 1, ln 8-15; col 4, ln 19-47; col 5, ln 62 to col 6, ln 31; Fig. 9); wherein at all times during the ventilation the fluid supply rate and fluid discharge rate are controlled and determined alone by the ventilation device and not by the patient, so that exhalation cannot take place passively with the energy stored in the elastic tissue elements of lung and thorax driving the exhalation (col 1, ln 8-15; col 2, ln 20-55; col 4, ln 4-47; Examiner notes: Ernst discloses the ventilation device in which flow and pressure of the respiration gas are automatically regulated during inspiration and expiration and wherein the ventilation device replaces the respiratory function in patients. As such, the at all times the control device is controlling the ventilation, and exhalation is not triggered by the patient and occurs by the active application of negative pressure.).
Ernst does not specifically disclose the ventilation device for ventilating the patient wherein the control device is configured to regulate at least one ventilation process such that there is the fluid supply rate [milliliter/second] is substantially constant during an entirety of the inhalation or there is the fluid discharge rate [milliliter/second] is substantially constant during an entirety of the exhalation.
Gropper teaches a mechanical ventilator comprising a control device (56; Fig. 4; col 8, ln 4-27) is configured to regulate at least one ventilation process such that there is the fluid supply rate [milliliter/second] is substantially constant during an entirety of the inhalation (Fig. 2; col 4, ln 64 to col 5, ln 21; col 8, ln 57 to col 9, ln 8) for the purpose of delivering the fluid using a square waveform such that the proximal pressure increases approximately linearly throughout the inspiratory phase to a peak inspiratory pressure (col 5, ln 3-16).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the ventilation device of Ernst to include the control device is configured to regulate at least one ventilation process such that there is the fluid supply rate [milliliter/second] is substantially constant during an entirety of the inhalation as taught by Gropper for the purpose of delivering the fluid using a square waveform such that the proximal pressure increases approximately linearly throughout the inspiratory phase to a peak inspiratory pressure (See Gropper: col 5, ln 3-16.
Regarding Claim 11, the modified device of Ernst discloses the ventilation device for ventilating the patient wherein the control device regulates at least one ventilation process.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ernst in view of Gropper as applied to claim 9 above, and further in view of further view of Martin (U.S. PG Pub. 2010/0108066).
Regarding claim 12, Ernst discloses the ventilation device for ventilating the patient, shown above.
Ernst does not explicitly disclose the ventilation device for ventilating the patient does wherein a continuous change of the pressure entails that the pressure remains constant for at most 0.5 s [seconds].
Martin teaches a continuous change of the pressure entails that the pressure remains constant for at most 0.5 s [seconds] (¶ 0023), discloses a continuous change of pressure and will inherently be constant for some fraction of time) for the purpose of slowing of a patient’s breathing during sleep by using positive pressure therapy comprising a variable pressure waveform delivered to the patient’s airway (¶ 0027).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the ventilation device of Ernst to include the continuous change of the pressure entails that the pressure remains constant for at most 0.5 s [seconds] as taught by Martin for the purpose of slowing of a patient’s breathing during sleep by using positive pressure therapy comprising a variable pressure waveform delivered to the patient’s airway (See Martin: ¶ 0027).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ernst in view of Nord in view of Gropper as applied to claim 13 above, in further view of Devires (U.S. Pat. 5,915,381) and Wondka (U.S. Pat. 8,770,193).
Regarding claim 21, the modified device of Ernst discloses the ventilation device for ventilating the patient, shown above.
The modified device of Ernst does not disclose the ventilation device for ventilating the patient wherein the patient is ventilated using a catheter which has a cross section of at most 30 mm2 [square millimeters] for the passage of at least one fluid supplied during the inhalation.
However, Devires teaches using an endotracheal tube to ventilate a patient (Col. 45 lines 35-49).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ernst to incorporate an endotracheal tube to deliver airflow to a patient as taught by Devires. The skilled artisan would have been motivated to make the modification in order to provide for a direct insertion of the breathing device to ensure proper ventilation is occurring.
The modified device of Ernst does not disclose the catheter having a cross section of at most 30 mm2.
However, Wondka teaches a catheter having a cross section of less than 30mm2 (Col. 18 Lines 30-38 discloses an outer diameter of at most 5mm, when converting the outer diameter of 5mm using the area formula (
A
=
π
r
2
) the cross section is found to be 19.625mm2 thus, being less than the claimed 30mm2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ernst to incorporate a catheter with a cross section of less than 30 mm2 as taught by Wondka for the purpose of ensuring the catheter is sized to fit in a patient.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ernst in view of Nord in view of Gropper as applied to claim 22 in further view of Martin (U.S. PG Pub. 2010/0108066).
Regarding claim 23, the modified device of Ernst discloses the ventilation device for ventilating the patient, shown above.
The modified device of Ernst does not explicitly disclose the ventilation device for ventilating the patient does wherein a continuous change of the pressure entails that the pressure remains constant for at most 0.5 s [seconds].
Martin teaches a continuous change of the pressure entails that the pressure remains constant for at most 0.5 s [seconds] (¶ 0023), discloses a continuous change of pressure and will inherently be constant for some fraction of time) for the purpose of slowing of a patient’s breathing during sleep by using positive pressure therapy comprising a variable pressure waveform delivered to the patient’s airway (¶ 0027).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Ernst to include the continuous change of the pressure entails that the pressure remains constant for at most 0.5 s [seconds] as taught by Martin for the purpose of slowing of a patient’s breathing during sleep by using positive pressure therapy comprising a variable pressure waveform delivered to the patient’s airway (See Martin: ¶ 0027).
Response to Arguments
Applicant’s arguments regarding the new limitations with respect to “wherein the control device is configured to regulate at least one ventilation process such that there is the fluid supply rate [milliliter/second] is substantially constant during an entirety of the inhalation or there is the fluid discharge rate [milliliter/second] is substantially constant during an entirety of the exhalation” as recited in independent claim 1 and similarly in independent claims 9, 13, and 22 have been considered but are moot because the arguments do not apply to the rejection in the previous office action (e.g., do not apply to claim limitations previously rejected). All arguments directed to new limitations in the amended claims are addressed in the 35 U.S.C. 103 rejection over Ernst in view of Nord in view of Gropper of independent claims 1, 13, and 22; and over Ernst in view of Gropper of independent claim 9, shown above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A.S.J. Lee (U.S. Pat. No. 3,045,668) discloses an artificial respirator wherein the control device is configured to regulate at least one ventilation process such that there is the fluid supply rate [milliliter/second] is substantially constant during an entirety of the inhalation (col 1, ln 10-12; col 1, ln 30-34; col 1, ln 41-46; col 2, ln 7-20; col 4, ln 6-36; col 7, ln 46 to col 8, ln 2), which has not yet been claimed.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785