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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/19/2026 has been entered.
Response to Amendment
This Office Action is in response to the arguments filed in the RCE on 05/19/2026. No claims are amended. Claims 1, 96-109 are pending in the instant application.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant presents arguments generally asserting that the prior art of Pelkus does not teach or suggest the limitation of “an oxygen concentrator positioned within a separate chamber within the housing isolated from the electronic components and the humidifier”. Examiner respectfully disagrees with this argument.
Examiner agrees that Pelkus is silent regarding exact positioning or arrangements for the oxygen concentrator in such embodiments, but disagrees that the teaching of Pelkus is insufficient to suggest/meet the limitations as currently filed.
First, as previously cited, Pelkus teaches a device in which humidified gases and compressed oxygen are delivered in parallel to the treatment chamber (Fig. 1-5). Pelkus additionally teaches that an oxygen concentrator (in substitution for the oxygen tank as shown in the Figures) can be included or built into the housing of the device (Paragraph 0051 and Claim 38). The humidification housing and chamber are self-sufficient and operable independent of the oxygen concentrator and the deliveries of the humidified gases and oxygen are shown to be parallel and separate from one another (Figs. 1-5, the gases from the humidifier and gas tank are delivered separately to the chamber; The oxygen is not delivered in/through the humidifier housing or mixed into the delivery conduit). Additionally, the electronics are disposed in their own discrete chamber and are separated from the humidifier assembly and conduits in which moisture/condensation may be generated (Paragraph 0052). For similar reasoning, electronics are also disposed separate from the oxygen concentrator delivery line which does not run through the chamber enclosing the electronics below the control panel lid (Fig. 1, Paragraph 0052).
Thus, in considering where the oxygen concentrator may be disposed in the housing from the teaching of Pelkus, it is held that it is obvious and reasonable to suggest that such a modification would entail an addition to the housing and/or disposal of the concentrator within a separate/isolated chamber from the other components of the humidifier and electronics. The compartmentalization of the other components within the housing provides support for the obviousness of providing the same separate compartmentalization for the oxygen concentrator, which is disclosed as an additional element which may be added onto/integrated into the housing.
To rephrase the core assertion, while Pelkus does not explicitly discuss an exact embodiment for location of the oxygen concentrator in the housing, Pelkus does disclose the two gas delivery sub-systems as separate and discrete/independent of one another. Both of these gas delivery pathways are also separate/isolated from the sensitive electronics controlling the overall device, as condensation/moisture is known to be generated from heated gas delivery or from gas compression/decompression. When considering how the oxygen concentrator may be incorporated as taught by Pelkus, it is reasonable and obvious that this would entail an addition to the housing or compartmentalization of the oxygen concentrator which is separate/isolated from the other components to maintain the separate gas flow lines and to protect the electronics from condensation.
All rejections are thus maintained and repeated 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.
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
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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