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 .
afforded.
Response to Amendment
This Office Action is in response to the amendments filed on 08/06/2025, as directed by the Non-Final Rejection on 05/07/2025. Claims 1 and 105 are amended. Claims 1, 96-109 are pending in the instant application.
Response to Arguments
Applicant's arguments filed 08/06/2025 have been fully considered but they are not persuasive.
Applicant presents arguments generally asserting that the device of Pelkus does not teach or suggest the oxygen concentrator being disposed in the housing within a chamber which is separated/isolated from the electronic components as currently recited in claim 1.
Examiner respectfully disagrees with this argument. Pelkus does have sufficient teaching or suggestion for the oxygen concentrator being disposed in a chamber of the housing separate/isolated from the electronics. Examiner agrees that Pelkus does not specifically disclose an oxygen concentrator in a particular isolated chamber of the housing, but Pelkus does teach that an oxygen concentrator can be included or built into the housing of the (Paragraph 0051 and Claim 38; The oxygen concentrator may be contained in the housing, but without specifics of the exact positioning or placement in any one chamber). To accommodate the oxygen concentrator as disclosed by Pelkus, there are only a limited number of configurations or potential layouts which can enable its inclusion. For example, inclusion of the oxygen concentrator may simply be adding an additional chamber onto the back or side of the device to contain the concentrator which can then be attached to the oxygen source/tubing to deliver the oxygen to the treatment chamber. The oxygen delivery of Pelkus is already parallel to that of the humidifier and thus it is a simple configuration/modification to include a separate chamber of the housing on the side/back of the cart to continue the parallel delivery. In such a case, the oxygen concentrator would be isolated from the electronic components in the chamber defined by the control panel lid 30 (see Fig. 1) and isolated from the humidifier located in the chamber of the cart 40. Furthermore, inclusion of gas delivery components into a chamber dedicated to the electronics would obviously be preferable to avoid, as condensation or temperature fluctuations would potentially disrupt operation of the electronics.
In an alternative modification, the oxygen concentrator could simply be positioned within the chamber of the cart 40 (see Fig. 8A). While the humidifier is located within the chamber of 40, the humidifier is also contained within its own housing/chamber (housing and lid 410 of humidifier 400, see Fig. 8A and Paragraph 0079) and would thus be isolated from the humidifier since the two would be spatially separated and fluidically isolated from one another. Furthermore, the limitation ‘isolated’ is broader than applicant may intend, as the oxygen delivery pathway and the humidification delivery pathway are both fluidically isolated from one another as they are delivered through distinct lines (Fig. 3B for instance). Since the chamber of 40 is not by default open to the gases of the humidifier and the gas delivery lines aren’t fluidically connected, they can be considered separate and isolated from one another. Thus, inclusion of the oxygen concentrator within the chamber of 40 would still have the concentrator isolated as currently claimed. Lastly, of the few possible configurations to introduce the oxygen concentrator, the oxygen concentrator could simply be disposed in its own sub-housing/sub-chamber within the chamber of 40 and would similarly be separate and isolated from both the electronics and the humidifier.
Thus, taken together, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Pelkus to include the oxygen concentrator in a chamber of the housing separated/isolated from the chamber of the electronic components.
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 and 96-109 are rejected under 35 U.S.C. 103 as obvious over Pelkus (U.S Publication No. 2010/0022941 A1) in view of Stryker (U.S Publication No. 2009/0048555 A1).
Regarding claim 1, Pelkus discloses a method for treating a wound, the method comprising:
introducing a human limb having a wound into a treatment chamber (see Paragraph 0046 and Fig. 3B-5, a patient inserts a limb having a wound into the vessel chamber 800 via the opening 169 in a lid 61 after cleaning of the wound), the treatment chamber comprising a substantially gas impermeable liner configured to receive the human limb (Fig. 1-5 and Paragraph 0012, 0047, the limb is placed into a liner 100 within the chamber which is impermeable to gas);
connecting the treatment chamber to a device with tubing (tubing 78/hoses 70/71 and pipe 818; see Paragraphs 0032, 0037, 0072 and Fig. 3B; The treatment chamber is connected to external sources of oxygen via tubing 78 and to a humidifier via hoses 70/71 and to a source water via pipe 818; also see Paragraphs 0031 and 0051 and Fig. 3B regarding the oxygen system, humidifier, or other components of the system being remote from the chamber of the system and thus connectable via the tubing), the device comprising:
a housing (see Figs. 1-8 and Claim 38, the cart 40 includes a housing which holds or connects to components),
a humidifier in fluid communication with a fluid source configured to contain a fluid, the humidifier configured to generate a mist from the fluid (Figs. 1, 3B and 8A/B and Paragraph 0031-0032, 0037, 0050; The system can include a humidifier, which can hold a solution of water and antibacterial agent for misting via control valve 50),
electronic components for controlling the device, wherein the electronic components are positioned within the housing (Fig. 3A-B and Paragraph 0032, 0036-0037, 0051, control electronics are disposed under the control panel 30 which are located in the housing of cart 40), and
an oxygen concentrator comprising an oxygen receiving port for receiving oxygen from an oxygen source and an oxygen dispensing port configured to dispense an O2 enriched gas (Paragraph 0051 and Claim 38, an oxygen concentrator receives a source of oxygen such an oxygen tank or air, and thus the concentrator must include a receiving port; The oxygen flows through tube 78 into an inlet port 77 and thus the concentrator must also have a dispensing port to dispense the concentrated O2 through the lid and across the limb);
surrounding the limb in the treatment chamber with the mist and the O2 enriched gas by flowing the mist and the O2 enriched gas from the device to the treatment chamber through the tubing (Paragraph 0031-0037; The humidified water/antibacterial mist and the oxygen are delivered to the treatment chambers through the tubing of 70/71 and 78, respectively).
Pelkus is silent regarding specifically wherein the treatment chamber is connected to a distinct device including the humidifier and oxygen concentrator, the treatment chamber being separately positionable relative to the device during use of the device.
However, Stryker teaches wherein the treatment chamber is connected to a distinct and separable device including the humidifier and an oxygen source (Fig. 1, Paragraph 0057, 0065; The chamber 12 may be connected to a drug delivery system of elements 20-36 which includes the humidifier 34 and the concentrated source of oxygen 28; also see Fig. 4-8, where the treatment chamber is remote from the gas delivery device/system) and wherein the treatment chamber is separately positionable relative to the device (see Paragraph 0065, 0080 and Figs. 4-8, the treatment chamber is connectable separate from the rest of the components and is thus separately positionable; also alternative embodiments include a movable treatment chamber to be placed over a limb or encompassing a part of the body).
Thus, it would have been obvious to one having ordinary skill in the prior art to have modified the device of Pelkus to include the treatment chamber being connected to a device including the humidifier and oxygen concentrator and separately postionable relative to the device in use, such as that taught by Stryker, in order to provide a modular assembly to treat different parts of the patient (Paragraph 0065, 0080 and Figs. 4-8; The components of the gas to be delivered and the types of treatment chambers can be switched to provide different treatments).
Pelkus is silent regarding specifically wherein the oxygen concentrator is positioned within a separate chamber within the housing isolated from electronic components and the humidifier.
However, Pelkus teaches wherein the electrical control components are located within a separate compartment isolated from the rest of the components (see Figs. 1-3A, where the control panel 30 includes a chamber which houses the electrical components 210/220/230/240 from the rest of the device) and additionally where the oxygen concentrator may be contained in the housing (see Claim 38, where the concentrator is contained in the housing of the device). Additionally, Pelkus teaches that the cart housing includes another chamber which is separate/isolated from the electronics for delivery of gases to the treatment chamber (see Fig. 3A, 8; the cart has a chamber below the control panel 30 where the humidifier is contained to deliver the gases through 71 to the treatment chamber via control valves; also see Response to arguments regarding the configuration of the oxygen concentrator as taught to be included). Furthermore, isolation of electronics from any gas/fluid sources which may introduce or promote condensation or temperature swings and thus is an obvious modification to prevent disruption of electrical controls.
Thus, it would have been obvious to one having ordinary skill in the prior art to have modified the device of Pelkus to include the oxygen concentrator in a separate chamber of the housing from that of the electronics, such as that taught by Pelkus, since the electronics are already disposed in a separate chamber away from the gas-delivery elements (Figs. 1-3A) and to prevent disruption to the electrical components of the device.
Regarding claim 96, the method of Pelkus discloses the method of claim 1.
Pelkus further discloses wherein surrounding the limb in the treatment chamber with an O2 enriched gas and the mist is performed without increasing the pressure around the limb by 22 mm Hg (Paragraph 0029 and 0031; The oxygen is delivered at a pressure slightly above atmospheric pressure; also see Paragraph 0063 and 0065, an adjustable valve 105 may prevent pressures within the treatment zone of liner 100 from increasing by 22 mm Hg, and additionally a foam cuff 90 will have fluid leakage when approaching an increase of 22 mm Hg and should not reach 22 mm Hg above ambient).
Regarding claim 97, the method of Pelkus discloses the method of claim 96.
Pelkus further discloses illuminating the wound with ultraviolet (UV) and/or infrared (IR) light sources positioned in the treatment chamber (Paragraph 0010-0012, 0029, 0036 ,0071, Claim 41; ultraviolet and/or infrared light delivered via a diode array is delivered to the limb and into the chamber for sterilization of the limb; The device is a wound treatment system and thus the wound would similarly be illuminated for sterilization and destruction of bacteria).
Regarding claim 98, the method of Pelkus discloses the method of claim 97.
Pelkus further discloses connecting electrical wiring that extends along the tubing to power the ultraviolet (UV) and/or infrared (IR) light sources (see Paragraph 0053 and Fig. 2-3, 8A; Electrical wiring 311 extends from a cable 240 at the top of the cart housing in which the humidifier is held and through the bottom of the carriage 15 and then through the chamber to the UV lights; Thus, the wiring extends along/beside the tubing that extends from the internal humidifier to the chamber; Additionally see Fig. 4B and 6A for example, where the electrical wiring extends along tubing 818 which provides water into the chamber).
Regarding claim 99, the method of Pelkus discloses the method of claim 1.
Pelkus further discloses wherein the human limb comprises a foot, and the treatment chamber comprises a bag configured to surround the foot (Fig. 3B-4B and Paragraph 0031, 0047; The patient’s limb, particularly a foot, is inserted into the chamber 800 and into a bag or liner 100).
Regarding claim 100, the method of Pelkus discloses the method of claim 1.
Pelkus further discloses sealing an opening of the treatment chamber with the human limb (Paragraph 0047, 0065 and Fig. 3B/4B; The limb is inserted through opening 161 and a cuff 90 and circular walls 67/68 seal around the limb).
Regarding claim 101, the method of Pelkus discloses the method of claim 1.
Pelkus further discloses surrounding the limb with a medication along with the mist and the O2 enriched gas (Paragraph 0031-0037; An antibacterial is administered along with the water mist and the O2).
Regarding claim 102, the method of Pelkus discloses the method of claim 101.
Pelkus further discloses wherein the medication is an antibiotic (Paragraph 0031-0037, 0045 and 0079; The antibacterial can be an antibiotic).
Regarding claim 103, the method of Pelkus discloses the method of claim 102.
Pelkus further discloses wherein the antibiotic comprises ionic silver (Paragraph 0079, the antibacterial agent can be ionic silver).
Regarding claim 104, the method of Pelkus discloses the method of claim 102.
Pelkus further discloses wherein the antibiotic is selected from the group consisting of betadine, isopropyl alcohol, bacitracin, hydrogen peroxide, and combinations thereof (Paragraph 0079, the antibacterial agent can include betadine, isopropyl alcohol, bacitracin, hydrogen peroxide; It is noted that a combination of hydrogen peroxide and silver solution can be used and thus teaches a combination of the antibacterial agents).
Regarding claim 105, Pelkus discloses a variable hyperoxia treatment apparatus (Paragraph 0029), comprising:
a housing (see Fig. 1 and 3A, the device includes a plastic carriage and cart 40 which houses the components) that at least partially encloses:
a humidifier in fluid communication with a fluid source configured to contain a fluid, the humidifier configured to generate a mist from the fluid (Figs. 1, 3B and 8A/B and Paragraph 0031-0032, 0037, 0050; The system can include a humidifier, which can hold a solution of water and antibacterial agent for misting via control valve 50), and the humidifier positioned within the housing and in fluid communication with a mist dispensing port (see Fig. 1, 8 and Paragraph 0032; Humidifier 400 is positioned within the housing of 40 and is in fluid communication with a hose 70/71 and valve 50 to deliver fluid to the chamber 830; Thus, the humidifier includes a dispensing port connected to the hose and the valve);
electronic components for controlling the variable hyperoxia treatment apparatus, wherein the electronic components are housed within the housing (Fig. 3A-B and Paragraph 0032, 0036-0037, 0051, control electronics are disposed under the control panel 30 which are located in the housing of cart 40; Additionally, the oxygen flows from the source and through an optional oxygen concentrator through tubing 78 and into the oxygen inlet port 77 of the lid 62; Since the electronics are not exposed to the oxygen gas flow, they are both fluidically and spatially isolated form the oxygen concentrator and oxygen receiving port); and
an oxygen concentrator comprising an oxygen receiving port for receiving oxygen from an oxygen source and an oxygen dispensing port configured to dispense an O2 enriched gas (Paragraph 0051 and Claim 38, an oxygen concentrator receives a source of oxygen such an oxygen tank or air, and thus the concentrator must include a receiving port; The oxygen flows through tube 78 into an inlet port 77 and thus the concentrator must also have a dispensing port to dispense the concentrated O2 through the lid and across the limb); and
a treatment chamber (vessel chamber 800, see Paragraph 0046 and Fig. 3B-5), the treatment chamber comprising a substantially gas impermeable liner configured to receive a human body part and form a treatment zone around the human body part (Fig. 1-5 and Paragraph 0012, 0047, a limb is placed into a liner 100 within the chamber which is impermeable to gas); and
tubing connecting the treatment chamber to the mist dispensing port and the oxygen dispensing port (Paragraph 0031-0037; The humidified water/antibacterial mist and the oxygen are delivered to the treatment chambers through the tubing of 70/71 and 78, respectively).
Pelkus is silent regarding wherein the treatment chamber is remotely located from and separately positionable during use relative to the housing of the hyperoxia treatment apparatus.
However, Stryker teaches wherein the treatment chamber is remotely located from and separately positionable during use relative to the housing of the humidifier (see Fig. 1 and Paragraphs 0011 and 0065, Claim 7; The humidifier is separable from and optionally/selectively in communication with the treatment chamber 12 and the housing of the humidifier is remote/distant from the treatment chamber; also see Fig. 4-8 and Paragraph 0080).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Pelkus to include the treatment chamber being separably positionable and remote from the housing of the humidifier, such as that taught by Stryker, in order to provide a selective/optional connection with the humidifier (Paragraph 0011, 0065 and Claim 7 for example; A remote/optional connection with the treatment chamber allows for removal of the humidifier if not needed) and to provide treatment to different parts/orientations of the body (Fig. 4-8 and Paragraph 0080 for example).
Pelkus is silent regarding specifically wherein the oxygen concentrator is positioned within the housing in a separate chamber isolated from electronic components and the humidifier.
However, Pelkus teaches wherein the electrical control components are located within a separate compartment isolated from the rest of the components (see Figs. 1-3A, where the control panel 30 includes a chamber which houses the electrical components 210/220/230/240 from the rest of the device) and additionally where the oxygen concentrator may be contained in the housing (see Claim 38, where the concentrator is contained in the housing of the device). Additionally, Pelkus teaches that the cart housing includes another chamber which is separate/isolated from the electronics for delivery of gases to the treatment chamber (see Fig. 3A, 8; the cart has a chamber below the control panel 30 where the humidifier is contained to deliver the gases through 71 to the treatment chamber via control valves; also see Response to arguments regarding the configuration of the oxygen concentrator as taught to be included). Furthermore, isolation of electronics from any gas/fluid sources which may introduce or promote condensation or temperature swings and thus is an obvious modification to prevent disruption of electrical controls.
Thus, it would have been obvious to one having ordinary skill in the prior art to have modified the device of Pelkus to include the oxygen concentrator in a separate chamber of the housing from that of the electronics, such as that taught by Pelkus, since the electronics are already disposed in a separate chamber away from the gas-delivery elements (Figs. 1-3A) and to prevent disruption to the electrical components of the device.
Regarding claim 106, the modified device of Pelkus discloses the device of claim 105.
Pelkus further discloses wherein the human body part comprises a foot, and the treatment chamber comprises a bag configured to surround the foot (Fig. 3B-4B and Paragraph 0031, 0047; The patient’s limb, particularly a foot, is inserted into the chamber 800 and into a bag or liner 100).
Regarding claim 107, the method device of Pelkus discloses the device of claim 105.
Pelkus further discloses wherein the treatment chamber comprises an opening configured to sealingly engage with the body part (Paragraph 0047, 0065 and Fig. 3B/4B; The limb is inserted through opening 161 and a cuff 90 and circular walls 67/68 seal around the limb).
Regarding claim 108, the method device of Pelkus discloses the device of claim 105.
Pelkus further discloses wherein the fluid comprises water (Paragraph 0031-0032; Humidified water is delivered to the chamber).
Regarding claim 109, the method device of Pelkus discloses the device of claim 105.
Pelkus further discloses wherein the treatment chamber further comprises ultraviolet (UV) and/or infrared (IR) light sources configured to illuminate the body part with UV and/or IR light (Paragraph 0010-0012, 0029, 0036, 0071, Claim 41; ultraviolet and/or infrared light delivered via a diode array is delivered to the limb and into the chamber for sterilization of the limb).
Conclusion
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 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 THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785