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 .
Status of Claims
Claims 158-177 are pending; all claims are previously presented and examined on the merits. No new matter is found.
Response to Arguments
Applicant's arguments filed 5/11/2026 have been fully considered but they are not persuasive.
Applicant argues, on page 6 of the Response, that primary reference Dorian requires a continuous outflow through the outlet (292) while secondary reference Ravikumar requires pressure relief valves (23 or 24) to remain closed until it is necessary to release the pressure within the reservoir. Examiner respectfully contends that Dorian does not require the outlet to have continuous outflow and subsequently modifying with Ravikumar would not lead to a result that is contrary to Dorian’s teaching. In [0157] Dorian discloses “[a]dditionally and/or alternatively” (emphasis added), suggesting that the continuous outflow is one of the embodiments of the disclosed invention and is not a necessary or critical aspect of the Dorian invention. Furthermore, even if, arguendo, that Dorian desired a continuous outflow in all embodiments, it is clear that the outflow will need to be sufficiently small to allow the reservoir to inflate, i.e., oxygen inflow will be substantially greater than that of gas outflow to result in an inflating reservoir. Therefore Dorian provides the possibility of flow regulation because the reservoir needs to inflate and also allow air to exit such that the oxygen concentration within the reservoir remains at a desirable level. In the same paragraph, [0157] in Dorian, the last sentence states “introduction or flow of a fluid or gas (such as air) through the one or more ports 290 or septa may be introduced not only for the infusion of an inflation fluid for inflating balloons, but also for the expansion of one or more encapsulated pads as well which may be used, e.g., for providing a compressive force.” Therefore Dorian is also contemplating the same function as that of Ravikumar, which is to apply a compressive force to the body through inflating the reservoir with a gas. In that case, one skilled in the art would find it obvious to glean from Ravikumar’s disclosure such that the compressive force will not build up too high to cause harm to the patient.
Applicant then argues that modifying with Ravikumar would both render Dorian’s device unsatisfactory for its intended purpose and result in a substantially different operating mode. Examiner maintains that since Dorian disclosed the continuous outflow being an alternative mode of operation, such a continuous flow is not required. Thus modifying with Ravikumar’s valve(s) that may usually be closed but would be open to vent an over-inflated gas reservoir would not result in a device unsatisfactory for its intended purpose and would not cause the Dorian device to operate in a different mode. Dorian’s device will continue to have oxygen building up to inflate the reservoir and exert a compressive force until the pressure inside the reservoir is so great that it would lead to harm to the patient.
For reasons above, the rejection in view of Dorian and Ravikumar is maintained and repeated below.
Claim Rejections - 35 USC § 103
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 158-176 are rejected under 35 U.S.C. 103 as being unpatentable over Dorian et al. (US 2014/0107561) in view of Ravikumar (US 2009/0124944).
Re Claim 158, Dorian discloses an apparatus (see Figs. 21A & 21B) for supplying fluid to a tissue of a patient, the apparatus comprising: a fluid receptacle (inflatable balloon 274) positionable at a tissue area of the patient, the fluid receptacle comprising one or more walls (top surface and bottom surface, can be more easily seen in Figs. 20A & 20B), a fluid inlet (gas inlet port 290) for receiving fluid into the fluid receptacle, and a fluid outlet (gas outlet port 292) for the passage of fluid from the fluid receptacle, a portion of the fluid receptacle being a tissue facing portion (the bottom surface of balloon 274 is meant to face the wound), and at least a portion of the tissue facing portion comprising a membrane ([0152] discloses protruding contact surface 280 facing the wound may be a covering as previously described, and in [0149] it is disclosed a protruding contact surface 264 shown in Figs. 19A-19B would have a covering substrate 230 that allow diffusion of oxygen, [0146] discloses substrate 230 allows unhindered diffusion of oxygen) adapted to allow molecules within the fluid to diffuse through the membrane to the tissue area of the patient ([0154] "any number of agents or medicaments may be introduced through the ports for application to the underlying wound"). Dorian does not disclose a pressure regulator associated with the fluid outlet. Ravikumar discloses a wound treatment apparatus (Fig. 1) comprising an inflatable fluid receptacle (air bladder chamber 14, Fig. 2A) that provides compression to the wound ([0032]), wherein the fluid reservoir is inflatable by a pump (pumping bulb 18) and is also equipped with an outlet path where a pressure relief valve (23 or 24, Fig. 2A) is provided to vent air from the chamber to the ambient environment when the chamber internal pressure reaches a maximum threshold ([0032]). It would have been obvious to one skilled in the art at the time of filing to modify Dorian by adding the pressure regulator taught by Ravikumar since Dorian's fluid receptacle also serves as a compression balloon ([0157]) and it would be safer to have an outlet that vents to the ambient environment, thus preventing over-compressing the wound.
Re Claim 159, Dorian and Ravikumar combine to disclose claim 158, and Ravikumar also discloses wherein the pressure regulator is positioned in spaced relation from the fluid receptacle (Fig. 2A shows the outlets where the valve 23 or 24 are extending a distance from the air bladder chamber 14).
Re Claim 160, Dorian and Ravikumar combine to disclose claim 158, and Ravikumar also discloses a fluid outlet conduit arranged in fluid communication with the fluid receptacle, wherein the pressure regulator is disposed on the fluid outlet conduit (clearly shown in Fig. 2A).
Re Claim 161, Dorian and Ravikumar combine to disclose claim 158, and Dorian further discloses wherein a fluid flow path through the fluid receptacle is defined by the one or more walls of the fluid receptacle, the fluid inlet and the fluid outlet.
Re Claim 162, Dorian and Ravikumar combine to disclose claim 161, and Dorian further discloses wherein the one or more walls is present between the fluid flow path and the tissue of the patient in use. Re Claim 163, Dorian and Ravikumar combine to disclose claim 158, and Dorian further discloses wherein the fluid inlet is adapted for providing a positive pressure within the fluid receptacle, and the one or more walls of the fluid receptacle define a positive pressure receptacle ([0157] "introduction or flow of a fluid or gas (such as air) through the one or more ports 290 for providing a compressive force"). Re Claim 164, Dorian and Ravikumar combine to disclose claim 158, and Dorian further discloses wherein the fluid receptacle is inflatable ("inflatable balloon 274," e.g., [0156]). Re Claim 165, Dorian and Ravikumar combine to disclose claim 158, and Ravikumar also discloses wherein the pressure regulator comprises a pressure relief valve ("automatic pressure relief valve 23 and a manual pressure relieve valve 24," [0032]).
Re Claim 166, Dorian and Ravikumar combine to disclose claim 158, and Ravikumar also discloses wherein the pressure regulator is configurable to relieve pressure within the receptacle when the pressure within the receptacle reaches a threshold value ([0032]).
Re Claim 167, Dorian and Ravikumar combine to disclose claim 158, and Dorian also discloses wherein the pressure regulator is configurable to adjust the pressure threshold value (manual pressure relief valve 24 is controlled manually and thus the threshold is determined by the user).
Re Claim 168, Dorian and Ravikumar combine to disclose claim 158, but neither Dorian nor Ravikumar wherein the pressure regulator comprises a conduit having a small internal diameter and/or a long length to generate a large resistance to fluid flow exiting the fluid receptacle. However, the terms "small," "long" and "large" are not expressly defined in the current claim and therefore one skilled in the art can reasonably interpret whatever dimensions to fit the claim terms. Additionally, Ravikumar shows that the outlet/valve (23 or 24) to have a smaller dimension than the air bladder chamber (14) and that the outlet/valve extends away from the air bladder chamber for a length about as long as the longer dimension of the air bladder chamber (Fig. 2A), thus suggesting to one skilled in the art that the outlet conduit has a small diameter and a long length, thereby expected to generate a large resistance to flow.
Re Claim 169, Dorian and Ravikumar combine to disclose claim 158, and Dorian also discloses wherein the fluid receptacle comprises multiple layers, comprising a first layer (wound facing layer that forms protruding portion 276 of the balloon 274) configured to form a tissue facing layer and a second layer (the top side of balloon 274). wherein the second layer includes one or more apertures (port 292) configured to permit fluid within the fluid receptacle to pass there through to exit the fluid receptacle.
Re Claim 170, Dorian and Ravikumar combine to disclose claim 169, and Dorian further disclose the one or more apertures are configured to provide pressure relief within the fluid receptacle (gas outlet port 292 necessarily lets out gas and therefore relieves pressure).
Re Claim 171, Dorian and Ravikumar combine to disclose claim 158, and Dorian also discloses a fluid source in fluid communication with the fluid inlet and adapted to provide a substantially continuous supply of fluid to the fluid receptacle (implied in [0154]).
Re Claim 172, Dorian and Ravikumar combine to disclose claim 158, and Dorian also discloses wherein the fluid comprises a therapeutic gas comprising one or more of oxygen (e.g., [0156]), carbon dioxide, and carbon monoxide.
Re Claim 173, Dorian and Ravikumar combine to disclose claim 158, and Dorian also discloses wherein the receptacle is substantially hollow ([0151] discloses "compressible pad or inflatable balloon" and thus implying that the balloon is hollow and is an alternative to earlier embodiments that use a compressible pad, such as shown in Fig. 19A).
Re Claim 174, Dorian and Ravikumar combine to disclose claim 158, and Dorian also discloses structures associated with the tissue facing portion of the receptacle, the structures being configured to face the tissue of the patient, wherein the structures are microstructures and/or wherein the structures comprise formations which protrude from the one or more walls of the receptacle (at least [0037], also [0152]).
Re Claim 175, Dorian and Ravikumar combine to disclose claim 158, and Dorian also discloses wherein the membrane adapted to allow molecules within the fluid to diffuse through the membrane to the tissue area is substantially pore free (see at least [0082] disclosing that the oxygen-diffusive substrate be formed of a coating that would fill gaps between fibers, implying that pore-free substrate is at least one of the options for allowing oxygen to diffuse into the wound).
Re Claim 176, Dorian and Ravikumar combine to disclose claim 158, and Dorian also discloses wherein the membrane is impermeable to bulk transport of fluid (implied because balloon 274 needs to inflate sufficiently to exert compression on the wound, [0157]).
Claim 177 is rejected under 35 U.S.C. 103 as being unpatentable over Dorian and Ravikumar as applied to claim 158 above, and further in view of Locke et al. (US 2012/0302979).
Re Claim 177, Dorian and Ravikumar combine to disclose claim 158, further comprising a cover positionable over the fluid receptacle at the tissue area of the patient to form a compartment substantially bounded by the cover, the receptacle and the tissue area, wherein the compartment is pressurised during use to form a negative pressure compartment. Locke discloses a wound dressing having a balloon (e.g., filler member 125) that exerts positive pressure on the wound, wherein the balloon is further surrounding by a negative pressure environment (where manifold 121 is located, see [0027], with reduced pressure source 151 generating the necessary suction) that is sealed by a cover (drape 110). It would have been obvious to one skilled in the art at the time of filing to modify with Locke to further promote wound healing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Felding (US 2014/0336564) discloses a wound treatment system that forms an enclosed volume over a wound site and means to finely regulate the oxygen concentration within said enclosed volume.
Blott et al. (US 2012/0130325) discloses a wound treatment system the circulates a fluid to/from the wound and uses ultrafiltration/dialysis principles, via a diffusion process, to remove deleterious components from said fluid.
Shaffer et al. (US 2007/0166357) discloses a bandage having a reservoir of oxygen that diffuses through a membrane wall of the reservoir to reach the skin. The reservoir does not have an inlet or an outlet.
Smith (US 2007/0118096) discloses a wound care system wherein oxygen is delivered ([0055]) into the wound space sealed by a drape. The wound care system further includes an oxygen diffusion sensor (45) to measure the diffusion of oxygen into the wound ([0076]).
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.
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
18 July 2026
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