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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-6, 10-12, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin (US 20070293830 A1).
Regarding Claim 1, Martin teaches a system (apparatus for cleansing wounds, see Abstract) comprising:
a drainage structure (chamber 94 forming an outlet manifold from which tubules 99 radiate hemispherically and run to the scaffold to end in openings 100 to collect the fluid directly from the wound, see Figures7a-b; Paragraph [0465]) comprising:
a perforated tube (pipes, tubes, or tubules may comprise a blind bore with perforations, apertures, holes, openings, orifices, slits or slots along the pipes, etc., see Paragraph [0275]);
a scaffolding sized and shaped to be placed inside of a percutaneous space (a biodegradable scaffold located under the backing layer and configured to be placed in contact with a wound bed in use, see Paragraph [0035]) and configured to maintain a position of the perforated tube so that fluid is introduced into the perforated tube (tubes or tubules that radiate from an outlet or inlet manifold to the scaffold to end in apertures and deliver the aspirating fluid or collected fluid directly to the scaffold and wound bed via the apertures, see Paragraph [0272]); and
a line (outlet pipe 47) connecting the perforated tubing to a negative pressure device or positive pressure device to transfer fluid from the percutaneous space (any pump with a discrete means for aspirate flow regulation, connected to a fluid offtake tube, and/or means for supply flow regulation, connected to a fluid supply tube, see Paragraph [0089]), wherein the line is in communication with the scaffolding (outlet pipe 47 pass through and/or under the wound-facing face of the backing layer to run over the scaffold, see Paragraph [0275]) so that the fluid is transferred in a manner that is continuous, variable, or pulsed (pump of any these types may also suitably be one that is capable of pulsed, continuous, variable and/or automated and/or programmable fluid movement, see Paragraph [0112]).
Regarding Claim 3, Martin further teaches wherein the drainage structure is subjected to intermittent pressure from the negative pressure device (pump of any these types may also suitably be one that is capable of pulsed fluid movement, see Paragraph [0112]).
Regarding Claim 4, Martin further teaches wherein the scaffolding is resorbable (scaffold is left between the wound film dressing and the wound bed to biodegrade, see Paragraph [0044]).
Regarding Claim 5, Martin further teaches wherein the scaffolding holds the perforated tube open to spread out the perforated tube and increase surface area of the perforated tube (tubes or tubules that radiate from an outlet or inlet manifold to the scaffold to end in apertures, see Figure 7b; Paragraph [0465]).
Regarding Claim 6, Martin further teaches a second scaffolding spaced apart from the scaffolding (the scaffold is in an essentially two-dimensional apertured, semi-rigid form mesh, net, web or lattice, see Paragraph [0071]; wherein the different strands of the mesh web or lattice can be considered the second scaffolding spaced apart from each other).
Regarding Claim 10, Martin further teaches wherein the perforated tube is flexible (tubes, pipes or tubules are resiliently flexible, e.g. elastomeric, and preferably soft, see Paragraph [0278[) includes a lumen or a space for fluid to transfer therethrough (pipes having a lumen to carry/delivery fluid to/from the wound, see Paragraph [0040]).
Regarding Claim 11, Martin teaches all of the limitations as discussed above in Claim 10 and Martin further teaches wherein the perforated tube (99) is arranged in an overlapping relationship and the scaffolding secures the perforated tube in the overlapping relationship so that fluid is removable through the perforated tube (tubes or tubules that run over the scaffold, see Paragraph [0466]).
Regarding Claim 12, Martin teaches all of the limitations as discussed above in Claim 10 and Martin further teaches wherein the perforated tube (99) is in communication with a tubing channel (pipes 97) that routes the liquid from the perforated tube to the positive pressure device (to an inlet pipe 46 that is connected to positive pressure pump, see Paragraph [0101]).
Regarding Claim 15, Martin further teaches a reservoir in communication with the drainage structure, wherein the reservoir is configured to collect fluid collected through the drainage structure (the aspirate in the fluid offtake tube downstream of the wound dressing may be aspirated into a collection vessel, see Paragraph [0086]).
Regarding Claim 16, Martin further teaches wherein the scaffolding prevents tissue from growing into the drainage structure by supporting the tissue away from the perforated tubing (the scaffold prevents the overgrowth of tissue in the wound area, see Paragraph [0045]).
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.
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.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Martin (US 20070293830 A1).
Regarding Claim 7, Martin teaches all of the limitations as discussed above in Claim 6 and Martin further teaches wherein perforated tube (99) is connected to the scaffolding and the second scaffolding (radiate from an outlet or inlet manifold to the scaffold to end in apertures, see Paragraph [0465]). However, Martin does not explicitly disclose wherein perforated tube is connected to the scaffolding and the second scaffolding at points of intersection.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the perforated tube to be located on to the scaffolding and the second scaffolding at points of intersection, since the claims to the perforated tube, which read on the prior art expect with regard to the position of the perforated tube would not have modified the operation of the device (collecting fluid from wound). The particular placement of the perforated tube would be obvious matter of design choice to one skilled in the art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.). See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).
Regarding Claim 8, Martin teaches all of the limitations as discussed above in Claim 7 and Martin further teaches wherein the scaffolding and the second scaffolding are spaced apart so that fluid is passable between the scaffolding and the second scaffolding into the perforated tube (an apertured or holed scaffold comprises a section of biodegradable polymer mesh, which permits fluid supply towards the wound bed, the withdrawal of tissue fluid through the pores of the scaffold, see Paragraph [0076]).
Regarding Claim 9, Martin teaches all of the limitations, as discussed above in Claim 7 and Martin further teaches a port (hemispherical membrane 92) that includes a film connected to the scaffolding and the second scaffolding and the port assists in guiding fluid into the perforated tube (openings that deliver the fluid directly to the wound bed over an extended area, in the form of one or more inflatable hollow bodies defined by a film sheet or membrane, see Paragraph [0168]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Martin (US 20070293830 A1) in view of Locke et al. (US 20130131616 A1), hereinafter referred to as “Locke”.
Regarding Claim 13, Martin teaches all of the limitations, as discussed above in Claim 1. However, Martin does not explicitly disclose wherein the drainage structure is configured to provide treatment to two separate wounds.
Locke teaches a system (a system for treating multiple tissue sites of a patient, see Abstract; Figure 9) comprising: a drainage structure (multi-path connector 961 includes four connection ports, one for receiving each of the reduced pressure delivery tubes 956 and one for receiving a supply tube 963 fluidly connected between the multi-path connector 961 and a therapy unit 958, see Paragraph [0061]) wherein the drainage structure is configured to provide treatment to two separate wounds (tissue sites 902, see Figure 9).
Martin and Locke are analogous art because both disclose a negative pressure wound therapy dressing.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the drainage structure of Martin and further include wherein the drainage structure is configured to provide treatment to two separate wounds, as taught by Locke. Locke teaches it may be necessary to treat a patient having a plurality of tissue sites requiring treatment. This is particularly true of patients injured by burns, war, or other trauma. Moreover, the plurality of tissue sites may need to be treated in the field or during transportation to a hospital or other care facility (see Paragraph [0006]).
Regarding Claim 14, Martin and Locke teach all of the limitations, as discussed above in Claim 13 and Martin further teaches a reservoir of material, wherein the reservoir of material comprises pain-relief, treatment of a disease, treatment of an infection, or a combination thereof (a fluid reservoir connected by a fluid supply tube to an inlet pipe, see Paragraph [0036]; the fluid reservoir which contains nutrients for wound cells to aid proliferation, and other molecules that are beneficially involved in wound healing and/or that are favorable to the wound healing process, see Paragraph [0043]).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Martin (US 20070293830 A1) in view of Hutchinson et al. (US 8216175 B2), hereinafter referred to as “Hutchinson”.
Regarding Claim 17, Martin teaches all of the limitations, as discussed above in Claim 1. However, Martin does not explicitly disclose wherein the perforated tube is encapsulated within the scaffolding.
Hutchinson teaches a system (system 200, see Figure 2A) comprising: a drainage structure (removes fluids from the interstitial and intracellular spaces of a tissue site 204 by way of a fluid removal subsystem 203, see Col. 9 lines 24-26;) comprising: a perforated tube (fluid-removal subsystem 203 comprising a plurality of tributary conduits 205, see Col. 13 lines 30-38); a scaffolding (leg manifold member 260) sized and shaped to be placed inside of a percutaneous space (placed in or near a first paracolic gutter 208, see Figure 2A-B) wherein the perforated tube is encapsulated within the scaffolding (tributary conduits 205 encapsulated in member 260, see Figure 2B).
Martin and Hutchinson are analogous art because both disclose a negative pressure would dressing.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the scaffolding of Martin and further include wherein the perforated tube is encapsulated within the scaffolding, as taught by Hutchinson. Hutchinson teaches technical advantages of the encapsulation may include that fluids from the tissue water spaces may be removed in a controlled manner. Another advantage is that it may help reduce intraabdominal pressure (IAP) and reduce organ damage. Another advantage may be that the system and method readily remove ascites and other fluids from the abdominal cavity. Another advantage may be that portions of a system can readily be placed in the paracolic gutters (see Col. 3 lines 23-39).
Regarding Claim 18, Martin and Hutchinson teach all of the limitations, as discussed above in Claim 17 and Martin further teaches wherein the drainage structure (chamber 94 forming an outlet manifold) is in communication with a fluid reservoir that is located external to the percutaneous space (connected to outlet pipe 47 may be aspirated into a collection vessel external, see Paragraph [0086]).
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Martin and Hutchinson as applied to claim 18 above, and further in view of Capone et al. (US 20140228762 A1), hereinafter referred to as “Capone”.
Regarding Claim 19, Martin and Hutchinson teach all of the limitations, as discussed above in Claim 17. However, Martin and Hutchinson do not explicitly disclose wherein the fluid reservoir is replaceable when the fluid reservoir fills so that the fluid reservoir is configured to accept additional fluid.
Capone teaches a system (a fluid pump device 10 and an associated drive and actuating system for continuous multi-fluid delivery applications in medical diagnostic and therapeutic procedures wherein one or more fluids are infused/injected into a patient, see Paragraph [0003]) comprising: a fluid reservoir (fluid supply section 20 includes one or more fluid source containers 30 containing various fluids to be supplied to the pump 10, see Figure 1 and 40), wherein the fluid reservoir is replaceable when the fluid reservoir fills so that the fluid reservoir is configured to accept additional fluid (the fluid supply set 32 may allow the fluid source containers 30 to be replaced without contamination of the pump 10, see Paragraph [0189]).
Martin, Hutchinson, and Capone are analogous art because all disclose a fluid reservoir to supply fluids to a patient.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the fluid reservoir of Modified Martin and further include fluid reservoir wherein the fluid reservoir is replaceable when the fluid reservoir fills so that the fluid reservoir is configured to accept additional fluid, as taught by Capone. Capone teaches the replaceable reservoir allow the pump to be intended for multiple uses prior to disposal. Such multiple uses may be for multiple patients or for a multiple and discrete number of uses in medical diagnostic and therapeutic procedures which may involve a single or multiple patients (see Paragraph [0113]).
Regarding Claim 20, Modified Martin teaches all of the limitations as discussed above in Claim 19 and Capone further teaches wherein the fluid reservoir (20) is compartmentalized into segmented structures (each fluid source is compartmentalize in their own container 30, see Figure 1).
Regarding Claim 21, Modified Martin teaches all of the limitations as discussed above in Claim 20 and Capone further teaches wherein the segmented structures are rigid walls that restrict movement of fluid within the fluid reservoir (fluid source containers 30 being define by their own container walls restricting movement within fluid supply section 20, see Figure 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kazala et al. (US 8920395 B2) teaches a system (see Abstract; Figure 1) comprising:
a drainage structure (reduced-pressure interface 126) comprising:
a scaffolding sized and shaped to be placed inside of a percutaneous space (inflatable bladders 108 that may be fluidly coupled to one another by one or more distribution conduits 110 placed on a tissue site 102); and
a line (128) connecting the perforated tubing to a negative pressure device or positive pressure device to transfer fluid from the percutaneous space (reduced-pressure source 107), wherein the line is in communication with the scaffolding so that the fluid is transferred in a manner that is continuous, variable, or pulsed (a reduced pressure, such as a vacuum pump providing continuous pressure, see Col. 3 line 50).
However, Wu fails to teach a perforated tube and the scaffolding configured to maintain a position of the perforated tube so that fluid is introduced into the perforated tube.
Wu et al. (US 8444614 B2) teaches a system (see Abstract; Figure 1A) comprising: a drainage structure (a static negative pressure device 100) comprising:
a perforated tube (collection chamber 120 may comprise a plurality of openings 150);
a scaffolding (a contact layer 130) sized and shaped to be placed inside of a percutaneous space and configured to maintain a position of the perforated tube so that fluid is introduced into the perforated tube (the contact layer 130, the sealant layer 110, and the collection chamber 120 may be coupled or integrated together, see Col. 10 lines 43-56); and
a line (an external evacuator device 270, such as a durable medical equipment evacuator or a constant force syringe, see Figure 2) connecting the perforated tubing to a negative pressure device or positive pressure device to transfer fluid from the percutaneous space, wherein the line is in communication with the scaffolding so that the fluid is transferred in a manner that is continuous, variable, or pulsed (the collection chamber can then be re-evacuated using an external evacuator 270 introduced through the opening 276 of the evacuator fitting 278, see Col. 13 lines 20-22).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC RASSAVONG/ (8/6/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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