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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 5-17, 38-50, 57, 58, 64, and 65 in the reply filed on 11/25/2025 is acknowledged. The examiner submits claim 57 is dependent on nonelected claim 53 and should also be withdrawn. Additionally, claim 64 is dependent on nonelected claim 63 and should also be withdrawn.
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, 7-17, 38-43, 45-50, 58, and 65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asefi et al. WO 2019070133.
As to claim 1, Asefi teaches a device 101, 2501, 2601,3101, 3901 for implantation at a treatment site (Abstract; page 11, lines 19-22) in the body of a patient for the removal of fluid from the treatment site (Figs. 2A-4, 29, 32, 35a-36b, 41-42;page 22, lines 3-4);
the device comprising a conduit structure 2514, 2614, 2114 (Figs. 21, 22, 27a, 27b; page 20 , lines 5-10), 109,209,309,409, (Fig. 4a-5d) at least in part defining a fluid removal lumen (Fig. 32), and
a porous bioresorbable sheath surrounding a portion of the conduit structure (page 4, lines 4-10; Figs. 21-25);
wherein the conduit structure comprises a removable component configured for removal from within the bioresorbable sheath and the treatment site upon completion of treatment (page 20, lines 22-24).
As to claim 7, Asefi teaches the sheath comprises a top sheet that wraps over a top part of the conduit structure, and a bottom sheet that wraps over a bottom part of the conduit structure, wherein the top and bottom sheets are joined around the conduit structure along a side seam (page 4, lines 14-18, Figs 5a-5d).
As to claim 8, the top and bottom sheets are stitched together (Asefi page 4, lines 14-16, page 16, lines 26-29).
As to claim 9, the sheath forms one or more flange(s) or tab(s) extending beyond the side seam, for securing the device to tissue at the treatment site (page 16, lines 26-34).
As to claim 10, the flanges or tabs comprise two layers, and the layers are attached at or near an edge of the flange or tab (Figs. 5a-5d).
As to claim 11, the apertures in the sheath are provided on upper and lower surfaces of the device (page 16, lines 35-38; Figs. 8a-9).
As to claim 12, the sheath comprises an end section proximal an inlet and outlet of the device, configured to prevent or minimize the ingress of wound debris into the conduit structure (Figs. 14d and 15a).
As to claim 13, the end section of the sheath does not comprise through apertures – where Asefi teaches the apertures may be in the top layer or bottom layer only (page 17, lines 1-10).
As to claim 14, an end of the sheath distal an inlet and outlet of the device is closed (Figure 15b).
As to claim 15, an end of the sheath distal an inlet and outlet of the device is open (Fig. 8b).
As to claim 16, Asefi teaches the sheath comprises one or more layers of extracellular matrix (ECM) or polymeric material (page 4, lines 26-31; page 24, lines 21-26).
As to claim 17, Asefi teaches the ECM is formed from decellularised propria-submucosa of a ruminant forestomach (page 4, lines 26-31).
As to claim 38, Asefi teaches the treatment site 102 is a region between surfaces or planes of muscle tissue, connective tissue and/or or skin tissue that have been separated during surgery or as a result of trauma, or a region within a layer of tissue (Asefi page 1, lines 14-15; page 5, lines 1-3; page 11, lines 22-24).
As to claims 39 and 40, the sheath comprises a sealing end section free from apertures and having a tight fit with the underlying portion of the conduit structure and the sealing end section of the sheath extends over a portion of the conduit structure that comprises fluid impervious walls (Figs. 13a, 16a, 22, and 32).
As to claims 41 and 42, the cross-sectional area of the sheath and the underlying conduit structure is reduced and tapered along at least a portion of the sealing section (Figure 4 and 12a-18a; page 18, lines 10-14).
As to claim 43, Asefi teaches a device 101, 2501, 2601,3101, 3901 for implantation at a treatment site (Abstract; page 11, lines 19-22) in the body of a patient for the removal of fluid from the treatment site (Figs. 2A-4, 29, 32, 35a-36b, 41-42;page 22, lines 3-4);
the device comprising a conduit structure 2514, 2614, 2114 (Figs. 21, 22, 27a, 27b; page 20 , lines 5-10), 109,209,309,409, (Fig. 4a-5d) at least in part defining a fluid removal lumen (Fig. 32), and
a porous bioresorbable sheath surrounding a portion of the removable conduit structure (page 4, lines 4-10; Figs. 21-25; page 20, lines 22-24);
and comprising a plurality of apertures sized and positioned to enable fluid communication between the treatment site and the conduit structure while preventing blockages in the device (page 4, lines 4-13, Figs. 8-9).
As to claims 45 and 46, the sheath comprises a sealing end section free from apertures and having a tight fit with the underlying portion of the conduit structure and the sealing end section of the sheath extends over a portion of the conduit structure that comprises fluid impervious walls (Figs. 13a, 16a, 22, and 32; page 18, lines 10-14).
As to claims 47 and 48, the cross-sectional area of the sheath and the underlying conduit structure is reduced and tapered along at least a portion of the sealing section (Figures 4 and 12a-18a; page 18, lines 10-13).
As to claim 49, the device in claim 43 further comprising a port 111, 3411 (Fig. 3a and 32) in fluid communication with the lumen(s) of the conduit structure.
As to claim 50, the conduit structure comprises a removable component configured for removal from the treatment site upon completion of treatment (page 20, lines 22-24).
As to claim 58, the sheath comprises a sealing end section free from apertures and having a tight fit with the underlying portion of the conduit structure (Figs. 12a, 13a, 16a, 22, and 32; page 18, lines 10-14).
As to claim 65, Asefi teaches a device 101, 2501, 2601,3101, 3901 for implantation at a treatment site (Abstract; page 11, lines 19-22) in the body of a patient for the removal of fluid from the treatment site (Figs. 2A-4, 29, 32, 35a-36b, 41-42;; page 22, lines 3-4);
the device comprising:
a removable silicone a conduit structure having apertures through a wall thereof 2514, 2614, 2114 (Figs. 8, 9, 21, 22, 27a, 27b; page 4, lines 4-13; page 20 , lines 5-10), 109,209,309,409, (Fig. 4a-5d) at least in part defining a fluid removal lumen (Fig. 32), and
a porous bioresorbable sheath surrounding a portion of the removable conduit structure (page 4, lines 4-10; Figs. 21-25; page 20, lines 22-24);
the sheath comprising comprises one or more layers of extracellular matrix (ECM) or polymeric material (page 4, lines 26-31; page 24, lines 21-26);
wherein the conduit is configured for removal from within the bioresorbable sheath and the treatment site upon completion of treatment (page 20, lines 22-24).
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.
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 5, 6, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Asefi et al. WO 2019070133 in view of Dunn et al. US Patent Application Publication 2017/0189239.
As to claim 5, 6, and 44, Asefi teaches the present invention substantially as claimed. Asefi teaches the bioresorbable sheath comprises a plurality of apertures (page 4, lines 4-13, Figs. 8-9). Asefi further teaches in portions of the channel wall comprising apertures, the surface area of the apertures may be from about 20% of the surface area of the channel wall to about 70% (Asefi page 17, lines 24-27). However, Asefi does not specifically teach the area of the apertures. Dunn teaches a surgical cavity drainage and closure system using an implantable device to promote drainage (Dunn Abstract). Dunn teaches the device comprises a plurality of apertures which allow tissue contact through the drain device for the benefit of promoting wound healing and the sealing of capillaries. Dunn teaches the size, shape and distribution of the apertures can be varied according to individual needs. However, greater tissue contact across the device will promote better adhesion, drainage, and wound closure. Dunn teaches it is preferred that at least about 50%, 60%, or 70%, and preferably 75-80% of the total surface area (one side) of the drain device comprises apertures. Dunn further teaches the average individual aperture surface area can be in the range from about 1mm2 to about 5cm2 (Dunn para. 0034), which has a value in the claimed range of about 1mm2 or less. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to provide the aperture surface area of Dunn for the apertures of Asefi for the benefits taught in Dunn and since both prior art references are from the same field of endeavor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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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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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781