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, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/12/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 25-26, 28-31, 33-35, 37-46 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 25-26, 28-31, 33-35, 37-39 and 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Herken et al. (US 2013/0324894 A1) in view of Gattinoni (US 6,461,315 B1) and in further view of Hall et al. (US 2003/0004445 A1).
Regarding claim 25, Herken discloses an anteroposterior thoracic restriction device (chest compression system, Abstract and Figure 1), wherein said anteroposterior thoracic restriction device presents holding means comprising at least one reversible bilateral tightening strap (straps 5R and 5L, straps are spooled onto a drive spool located within the platform to tighten and/or loosen straps during use, Paragraph 0033 and Figure 1), and an anterior plate and configured for surrounding a patient's chest (load distributing panels 4R and 4L designed for placement over the anterior surface of the patient’s chest, Paragraph 0033 and Figure 1), a single compressible fluid bag configured to be held against the patient's sternum by said holding means (see single bladder 8 configured to be held against the patient’s sternum by said straps 5R and 5L, Figures 1-2 and Paragraph 0033) and the reversible bilateral tightening strap being arranged on either side of the single compressible fluid bag and capable of reversibly tightening said holding means around the patient's chest (straps 5R and 5L disposed on either side of the bladder 8, straps are spooled onto a drive spool to either tighten and/or loosen, Figures 1-2 and Paragraph 0033), wherein the amount of the fluid is configured to be at a constant volume in the single compressible fluid bag (the bladder 8 is operated in a static mode, such that it is filled and/or inflated prior to compressions, and therefore maintains a static volume, Paragraph 0064), wherein the strap and an anterior plate of said holding means are configured as an anteroposterior thoracic restriction device configured to be applied against the anterior part of the patient's chest so that the fluid bag is compressed between the anterior plate and the sternum of the patient's chest (straps 5R and 5L disposed on either side of the bladder 8, straps are spooled onto a drive spool located within the platform to tighten and/or loosen the straps during use, the means for tightening the straps includes a motor, drive train, and the drive spool upon which the straps spools during use, therefore the bladder 8 of constant volume is compressed between the load distribution panels 4R and 4L and the user’s chest, Figures 1-2 and Paragraph 0033), said holding means further comprising side tabs for connecting the anterior plate to the at least one tightening strap (straps 5R and 5L comprise side tabs/portions 3R and 3L for connecting to the load distribution panels 4R and 4L, Figure 1), wherein the anteroposterior thoracic restriction device further comprises a pressure sensor for measuring the pressure in the fluid bag (pressure sensor 39 in fluid communication with the bladder 8, Paragraph 0064).
However, although Herken teaches the chest compression system being used in conjunction with ventilation (Paragraph 0011 discusses use of chest compression system while patient is receiving ventilation), Herken doesn’t explicitly state an artificial ventilation system comprising a ventilator connected to a nasal and/or buccal and/or tracheal interface, for supplying air to the lungs of a patient; and although Herken teaches an anterior plate (load distribution panels 4R, 4L, Figures 1-2), Herken doesn’t specify if the plate is rigid or semi-rigid.
In regards to a ventilation system, Gattinoni teaches a system comprising a thoracic compression device comprising a bladder (a vest 24 is placed on patient 2, vest 24 includes two compartments 30A and 30B which can be selectively filled with pressurized fluid to impart pressure on the patient’s chest, while the patient is also receiving respiratory treatment via the ventilator 6, Figure 6 and Col.4 lines 64-67) and an artificial ventilation system comprising a ventilator connected to a nasal interface for supplying air to the lungs of a patient (patient 2 is connected to a ventilator 6 via a tubing system / patient interface 8 for receiving respiratory treatment, Figure 1 and Col. 4 lines 15-17).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Herken’s chest compression device to be used in combination with an artificial ventilator system for supplying air to the lungs of a patient, as taught by Gattinoni, as the use of a thoracic compression device in combination with a ventilator provides a safe and easy means of generating intrathoracic pressure while providing adequate ventilation to the patient, with the ventilator providing beneficial supplemental oxygen delivery to the patient.
In regards to the anterior plate being rigid or semi-rigid, Hall teaches a chest compression device (Abstract and Figure 1) comprising a bladder (bladder 4, Figure 12) and an anterior plate disposed above the bladder to therefore compress the bladder (compression plate 83 disposed over bladder 4, Paragraph 0046 and Figure 12), wherein the plate is rigid or semi rigid (rigid compression plate or surface, Paragraph 0051).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Herken’s chest compression device by having the load distribution panels be rigid or semi-rigid, as taught by Hall, as providing a rigid or semi-rigid material and/or surface above the compressible bladder may further aid in the depth of chest compressions generated by the system.
Regarding claim 26, Herken further discloses at least one tightening strap configured for depressing at least part of the patient's chest (straps 5R and 5L disposed on either side of the bladder 8, straps are spooled onto a drive spool located within the platform to tighten and/or loosen the straps during use, the means for tightening the straps includes a motor, drive train, and the drive spool upon which the straps spools during use, Paragraph 0033 and Figures 1-2).
Regarding claim 28, Herken further discloses wherein the holding means of the anteroposterior thoracic restriction device further comprises a rigid or semi-rigid posterior plate intended to be applied against the posterior part of the patient's chest (rigid platform 2 applied against posterior part of the patient’s chest, Figure 1 and Paragraph 0033).
Regarding claim 29, Herken further discloses wherein the strap of the holding means of the anteroposterior thoracic restriction device is a semi-rigid strap (straps 5R and 5L are spooled onto a drive spool, therefore consisting of a semi-rigid material, Paragraph 0033).
Regarding claim 30, Herken further discloses wherein the at least one tightening strap of the anteroposterior thoracic restriction device is a progressive tightening strap (straps 5R and 5L disposed on either side of the bladder 8, straps are spooled onto a drive spool located within the platform to tighten and/or loosen the straps during use, the means for tightening the straps includes a motor, drive train, and the drive spool upon which the straps spools during use, therefore the straps are fully capable of being progressively tightened as needed, Paragraph 0033 and Figures 1-2).
Regarding claim 31, Herken further discloses wherein the at least one tightening strap of the anteroposterior thoracic restriction device is anterolateral (see straps 5R and 5L disposed in an anterolateral location, Figures 1-2).
Regarding claim 33, Herken further discloses wherein said single compressible fluid bag of the anteroposterior thoracic restriction device contains a liquid (the bladder 8 is operated in a static mode, such that it is filled and/or inflated prior to compressions, therefore containing a liquid, Paragraph 0064).
Regarding claim 34, Herken further discloses wherein the amount of said fluid is constant in said single compressible fluid bag (the bladder 8 is operated in a static mode, such that it is filled and/or inflated prior to compressions, and therefore maintains a static volume, Paragraph 0064).
Regarding claim 35, Herken further discloses wherein the anterior strap or plate of the anteroposterior thoracic restriction device comprises a central housing for receiving said single compressible fluid bag (the bladder 8 is received and contacted by the inner surface of the load distribution panels 4R, 4L, forming an central housing for the bladder 8, Figures 7-8).
Regarding claim 37, Herken in view of Gattinoni and Hall teach an artificial ventilation system as claimed in claim 25, with Gattinoni further teaching a method to promote redistribution of ventilation to condensed areas in a patient in need of artificial ventilation (an apparatus for improving the distribution of gas in the lungs of a patient while receiving respiratory treatment via a ventilator 6, Abstract and Figure 1) with comprising the steps of: applying the anteroposterior thoracic restriction device of the artificial ventilation system against the thoracic cage of the patient in dorsal decubitus position (patient is placed in a supine position, Figure 1; a vest 24 is placed on patient 2, vest 24 includes two compartments 30A and 30B which can be selectively filled with pressurized fluid to impart pressure on the patient’s chest, while the patient is also receiving respiratory treatment via the ventilator 6, Figure 6 and Col.4 lines 64-67); bringing air into the lungs of the patient with the ventilator connected to a nasal and/or buccal and/or tracheal interface of the patient (patient is connected to a ventilator 6 via tubing 8, Figure 1); and simultaneously; applying a positive extrathoracic pressure to the anterior part of the thoracic cage (the controllable pressure exerted by the vest 24 via the compartments 30A/30B disposed on the patient’s chest is synchronized with the inspiration phase of the supply of respiratory gas from the ventilator, therefore as air is being supplied to the patent via the ventilator, a pressure is simultaneously being applied to the patient’s chest via the inflatable vest 24, Col. 3 lines 1-4), and Herken further teaching of the patient by tightening the holding means of the anteroposterior thoracic restriction device around the patient's chest (straps 5R and 5L disposed on either side of the bladder 8, straps are spooled onto a drive spool located within the platform to tighten and/or loosen the straps during use, the means for tightening the straps includes a motor, drive train, and the drive spool upon which the straps spools during use, therefore the straps are fully capable of being progressively tightened as needed, Paragraph 0033 and Figures 1-2) and measuring the compression in the compressible fluid bag during all ventilation (pressure sensor 39 in fluid communication with the bladder 8, Paragraph 0064).
Again, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Herken’s chest compression device to be used in combination with an artificial ventilator system for supplying air to the lungs of a patient simultaneously with the chest compressions, as taught by Gattinoni, as the use of a thoracic compression device in combination with a ventilator provides a safe and easy means of generating intrathoracic pressure while providing adequate ventilation to the patient, with the ventilator providing beneficial supplemental oxygen delivery to the patient.
Regarding claim 38, Herken further discloses wherein the at least one reversible bilateral tightening strap exerts an homogeneous pressure on both sides of the chest of the patient (straps 5R and 5L disposed on either side of the bladder 8, straps are spooled onto a drive spool located within the platform to tighten and/or loosen the straps during use, the means for tightening the straps includes a motor, drive train, and the drive spool upon which the straps spools during use, therefore the straps are fully capable of being progressively tightened as needed, Paragraph 0033 and Figures 1-2).
Regarding claim 39, Gattinoni further teaches wherein the patient has inhomogeneous distribution of lung lesions leading to overdistension of the anterior areas of the lungs and a lack of ventilation of the posterior condensed areas (the supplied pressure applied via the inflatable vest 24 will cause the breathing gas supplied from the ventilator 6 to become more evenly distributed in the lungs, in particular toward the lower or posterior regions of the lungs, Col. 4 lines 33-39; without this additional applied chest pressure, other parts of the lung may be exposed to pressures that may cause overdistension, Col. 1 lines 40-44).
Regarding claim 42, Herken further discloses wherein the anterior plate integrates a pressure sensor in direct communication with the bag (pressure sensor 39 in fluid communication with the bladder 8, Paragraph 0064).
Regarding claim 43, Herken further discloses wherein the fluid bag is attached to the inner wall of the anterior plate (see bladder 8 attached to an inner side/wall of the load distribution panel, Figure 2).
Regarding claim 44, Herken further discloses the restriction device is configured for automatic release (compression device may be operated automatically, Paragraph 0010).
Claim(s) 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Herken et al. (US 2013/0324894 A1) in view of Gattinoni (US 6,461,315 B1) and in further view of Hall et al. (US 2003/0004445 A1) and Sherman (US 2002/0177793 A1).
Regarding claim 40, Herken in view of Gattinoni and Hall teach the method to promote redistribution of ventilation to condensed areas in a patient in need of artificial ventilation of claim 37, however are silent wherein holding means comprises a strap and wherein the at least one tightening strap of the anteroposterior thoracic restriction device is held between the strap and the patient's chest and applies a pressure of between 20 and 150 cm of water (cmH2O) ± 20 in said single compressible fluid bag.
However, Sherman teaches a similar thoracic restriction device comprising a strap (chest compression device with compression belt 3, Figure 37 and Paragraph 0134), a fluid filled bladder (bladder 140 is located on the inner side of the compression vest over the sternum of the patient, Figure 37 and Paragraph 0134; bladder may be filled with any fluid such as water, Paragraph 0135), tightening means on either side of the fluid filled bag (chest compression belt 3 is repeatedly tightened about the chest of a patient through the action of tightening spools 7 located within support board 6, Paragraph 0077), further teaching operating at a minimum compressive pressure of 240 mmHg (a minimum effective pressure of about 240 mmHg is achieved in each compression, Paragraph 0135).
Therefore, it would have been obvious to one of ordinary skill in the art to use Herken’s device with a minimum effective compressive pressure of 240 mmHg, as such a value is art recognized to be a suitable minimum effective compressive pressure value for a similar type compression device, as exemplified by Sherman.
Regarding claim 41, Herken in view of Gattinoni and Hall teach the ventilation system as claimed in claim 25, however are silent wherein said single compressible fluid bag of the anteroposterior thoracic restriction device contains a liquid and the at least one tightening strap of the anteroposterior thoracic restriction device applies a pressure of between 20 and 150 cm of water (cmH2O) ± 20 in the single compressible fluid bag when said single compressible fluid bag is held between the strap and the patient's chest.
However, Sherman teaches a similar thoracic restriction device comprising a strap (chest compression device with compression belt 3, Figure 37 and Paragraph 0134), a fluid filled bladder (bladder 140 is located on the inner side of the compression vest over the sternum of the patient, Figure 37 and Paragraph 0134; bladder may be filled with any fluid such as water, Paragraph 0135), tightening means on either side of the fluid filled bag (chest compression belt 3 is repeatedly tightened about the chest of a patient through the action of tightening spools 7 located within support board 6, Paragraph 0077), further teaching operating at a minimum compressive pressure of 240 mmHg (a minimum effective pressure of about 240 mmHg is achieved in each compression, Paragraph 0135).
Therefore, it would have been obvious to one of ordinary skill in the art to use Herken’s device with a minimum effective compressive pressure of 240 mmHg, as such a value is an art recognized to be a suitable minimum effective compressive pressure value for a similar type compression device, as exemplified by Sherman.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Herken et al. (US 2013/0324894 A1) in view of Gattinoni (US 6,461,315 B1), Hall et al. (US 2003/0004445 A1) and in further view of Avitable et al. (US 2010/0081975 A1).
Regarding claim 45, Herken in view of Gattinoni and Hall teach the artificial ventilation system as claimed in claim 25, however are silent wherein the anterior plate is multi-perforated.
However, Avitable teaches a device configured to exert compressions on a user’s chest (compression device 10 may be wrapped around a user’s chest, Paragraph 0024 and Figure 1) comprising an anterior plate (layer 14, Figures 1-2) wherein the anterior plate/later is multi-perforated (layer 14 may comprise multiple perforation lines 93 extending across the layer, Paragraph 0034 and Figures 1-2).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Herken’s chest compression by having the anterior plate and/or load distribution panels be multi-perforated, as taught by Avitable, as providing an anterior plate/panel with multi-perforations may make the device more breathable and lightweight to the user, as the holes would allow for free air movement throughout the plate.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Herken et al. (US 2013/0324894 A1) in view of Gattinoni (US 6,461,315 B1), Hall et al. (US 2003/0004445 A1) and in further view of Biondo et al. (US 7,931,607 B2).
Regarding claim 46, Herken in view of Gattinoni and Hall teach the method to promote redistribution of ventilation to condensed areas in a patient in need of artificial ventilation of claim 37, however doesn’t explicitly state wherein the device is configured to be applied during acute respiratory distress syndrome (ARDS).
However, Biondo teaches a pulmonary therapy apparatus (Abstract and Figure 1) comprising a patient configured to received respiratory gas from a ventilator (ventilator tube 68, Figure 5 and Col. 10 lines 53-55), and a thoracic compression device (bladders 102 may be inflated to provide chest binding and compression when a ventilator is used to supply air or oxygen to the patient, Col. 11 lines 53-55 and Figure 8), wherein the device is configured to be applied during acute respiratory distress syndrome (ARDS) (Col. 10 lines 39-40)).
Therefore, it would have been obvious to one of ordinary skill in the art to use Herken’s device to treat acute respiratory distress syndrome, as taught by Biondo, as applying compressive forces to the user’s chest while the user is receiving oxygen or air from a ventilator source is an effective means to further increase oxygenation in a patient suffering from ARDS (Col. 10 lines 39-40 of Biondo).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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