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 and examined on the merits.
Information Disclosure Statement
The references cited by applicants in the information disclosure statements filed between 2/15/2024 and 10/3/2025 have been made of record. Examiner has considered the voluminous references to the best of her ability.
While the statements filed do not comply with the guidelines set forth in MPEP 2004 regarding both the number of references cited and the elimination of clearly irrelevant art and marginally cumulative information, compliance with these guidelines is not mandatory. Furthermore, 37 CFR 1.97 and 1.98 does not require that the information be material; rather, they allow for submission of information regardless of its pertinence to the claimed invention. Also, there is no requirement to explain the materiality of the submitted references. However, the cloaking of a clearly relevant reference by inclusion in a long list of citations may not comply with Applicant’s duty of disclosure. See Penn Yan Boats, Inc. v. Sea Lark boats Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338.
Applicant is advised that the MPEP states the following with respect to large information disclosure statements:
Although a concise explanation of the relevance of information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted. Concise explanations (especially those that point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more is highly relevant to patentability. MPEP § 609.04(a)(III).
This statement is in accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), states that forcing the Examiner to find “a needle in a haystack” is “probative of bad faith.” Id. at 1888. This case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Id. 1888.
The MPEP provides more support for this position. In a subsection entitled “Aids to Compliance With Duty of Disclosure,” item thirteen states:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant information and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of the most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp 948 (S.D. Fla. 1972) aff’d 479 F.2d 1338 (5th Cir 1974). See also MPEP § 2004.
Therefore, it is recommended that if any information that has been cited by Applicants in the previous disclosure statement is known to be material for patentability as defined by 37 CFR 1.56, Applicant should present a concise statement as to the relevance of that/those particular documents therein cited.
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
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
11 February 2026