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. Applicant’s amendment filed 05/21/2026 amended claims 57, 63, and 64 to depend from elected independent claim 43. Claims 57, 63, and 64 are now considered in the following rejection.
Response to Arguments
Applicant's arguments filed 05/21/2026 have been fully considered but they are not persuasive. Applicant has amended claim 1 to recite “wherein the bioresorbable sheath forms a tight fit with the underlying conduit structure to fluid-permeably seal the conduit structure and prevent or minimize the ingress of solid matter into the conduit structure”. Applicant cites the specification page 20, lines 28-36 as providing support for the amended limitations. However, in the original specification on page 20, lines 28-36 reads as follows:
The sheath 3 comprising a sealing end section 3d at the end of the sheath proximal the inlet and outlet, where the conduit 11 protrudes from the sheath 3. This end section 3d is free from apertures and extends over a portion of the conduit structure 11A that comprises fluid impervious walls (Further illustrated in Figures 7 to 10). This end second 3d forms a tight fit with the underlying conduit structure 11 and acts to provide a type of seal with the conduit structure 11 that prevents or reduces the ingress of wound debris, tissue debris and fat between the sheath 3 and conduit structure 11, which has the potential to cause blockages.
The aforementioned passage provides support for the end section of the sheath 3d, that is free from apertures, to provide a type of seal with the conduit structure 11 the prevents or reduces the ingress of solid matter into the conduit structure. The limitation “fluid-permeably seal” is not supported by the specification, and can be considered as new matter.
Regarding the rejection of claims 1, 7-17, 38-43, 45-50, 58, and 65 as being anticipated by Asefi et al. WO 2019/070133, Applicant argues in Asefi et al., it is the truss enclosed by the sheath that is placed within the treatment site and together define the channel which enables fluid flow at the treatment site, whereas the conduit of Asefi et al. is the means by which negative or positive pressure is communicated to the treatment device. Applicant argues in contrast, according to the claimed invention, the conduit provides for the removal of fluid, or the delivery of fluid, to the treatment site through the porous bioresorbable sheath. Accordingly, the conduit of Asefi et al. and the conduit of the instant claims are different in configuration and function. The examiner respectfully disagrees. While the conduits of Asefi do have a source of negative pressure attached, Asefi also teaches a reservoir located external to the body of the patient and in fluid communication with the conduit for receiving fluid from the conduit or delivering fluid to the conduit (page 5, lines 12-13). Thus, the conduits of Asefi also function to remove and deliver fluids to the treatment site.
Regarding the rejection of claims 5, 6, and 44 as being unpatentable over Asefi in view of Dunn et al. US 2017/0189239, Applicant argues the claims (independent claim 1) have been amended to require that the bioresorbable sheath surrounding the conduit structure fluid-permeably seals the apertures present in the conduit structure to prevent or minimize the ingress of solid matter. Applicant argues neither of the cited references either alone or in combination, teaches or suggests the invention as currently claimed. The examiner respectfully disagrees. The present invention teaches the sheath comprises a plurality of apertures positioned to enable fluid communication between the treatment site and the conduit structure (published application US 2024/0000616 para. 0011). The present invention further teaches the sheath comprises a sealing end section free from apertures and having a tight fit with the underlying portion of the conduit structure (US 2024/0000616 paras. 0030, 051). As stated above, the present disclosure teaches the body of the sheath as having apertures for enabling fluid communication between the treatment site. The present invention also teaches the fit of the sheath 3 over the conduit structure 11 should be tight to ensure the sheath isn’t sucked into the fluid removal lumen on the application of negative pressure, and to minimize the likelihood of wound debris entering the conduit structure other than through the sheath apertures 5 (US 2024/0000616 para. 0222). Based on Applicant’s own disclosure, the examiner interprets the sheath/conduit fit as providing somewhat of a barrier to wound debris, but is not fluid permeably sealed as the apertures permit fluid to move in and out of the conduit.
Applicant further argues there are apertures present in embodiments of the devices disclosed in Dunn et al, such as the apertures in the adhesion matrix, apertures 2. Applicant submits that the primary purpose for the apertures in Dunn is to facilitate tissue contact to promote would healing and, even if certain of the apertures disclosed in Dunn are configured to aid drainage (such as the drain tube channels of Dunn et al.), there is nothing in Dunn et al. that teaches or suggests the need for tight fitment of the bioresorbable sheath and fluid permeable sealing of any openings into a structure as currently claimed. Again, the present invention does not have support for ‘fluid-permeable seal”, only for a tight fitting sheath and underlying conduit. Additionally, the apertures of Asif/Dunn have the same aperture surface area in a range from about 1mm2 to about 5cm2, which meets the claim limitation of 1mm2 or less (Dunn para. 0034). Apertures have the same surface area would also provide openings that prevent or minimize solid matter ingress.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-11, 14-17, 40-44, 46-50, 57, 59, 63, 65-69 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a tight fit of the sheath 3 over the conduit structure 11, does not reasonably provide enablement for a fluid-permeable(ly) seal between the sheath and the conduit structure. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Applicant has amended claims 1 to recite “wherein the bioresorbable sheath forms a tight fit with the underlying conduit structure to fluid-permeably seal the conduit structure and prevent or minimize the ingress of solid matter into the conduit structure”. Applicant cites the specification page 20, lines 28-36 as providing support for the amended limitations. However, cited passage does not support the claimed “fluid-permeably seal”. What is taught in the specification is a tight fit between the sheath and conduit structure (US 2024/0000616 para. 0222).
Case law holds that applicant's specification must be "commensurately enabling [regarding the scope of the claims]" Ex parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1989) otherwise undue experimentation would be involved in determining how to practice and use applicant's invention. Although the statute itself does not use the phrase "undue experimentation", it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation as stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Specifically, in In re Wands the Court set forth a non-exhaustive list of factors to be considered in determining whether undue experimentation would be involved in making and/or using the claimed invention. These factors include, but are not limited to:
(a) the breadth of the claims;
(b) the nature of the invention;
(c) the state of the prior art;
(d) the level of one of ordinary skill;
(e) the level of predictability in the art;
(f) the amount of direction provided by the inventor;
(g) the existence of working examples; and
(h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Independent claims 1 and 43 recite “the bioresorbable sheath forms a tight fit with the with the underlying conduit structure to fluid-permeably seal the conduit structure and prevent of minimize the ingress of solid matter into the conduit structure” . Independent claim 65 recites “the porous bioresorbable sheath fluid-permeably seals said apertures of the removable conduit”. The present invention teaches the bioresorbable sheath 3 surrounding the conduit structure comprises a plurality of apertures 5 positioned to enable fluid communication across the sheath 3, between the treatment site and the conduit structure. Since the apertures function to provide fluid communication across the conduit structure, to fluid -permeably seal the apertures would contradict the function of the sheath/conduit.
Based on the amount of direction provided by the inventor (Wands Factor F) and the level of one of ordinary skill in the art (Wands Factor D), one of ordinary skill in the art would not be apprised on how to make the invention as no embodiments with an fluid-permeable seal between the sheath apertures and the conduit are disclosed in the present invention, which would still enable fluid communication between the sheath, conduit, and treatment site. Further based on the nature of the invention (Wands Factor B), the invention would not function as intended with sealed apertures.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 40-42 and 46-48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 40-42 depend from cancelled claim 39. It appears the claims intend to depend from independent claim 1. Correction is required.
Claims 46-48 depend from cancelled claim 45. It appears the claims intend to depend from independent claim 43. Correction is required.
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 1, 7-10, 14-17, 38, 40-43, 46-50, 59, 63, and 65-69 are rejected under 35 U.S.C. 103 as being unpatentable over 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).
Asefi does not specifically teach the bioresorbable sheath forms a tight fit with the underlying conduit structure to fluid-permeably seal the conduit structure and prevent or minimize the ingress of solid matter into the conduit structure. However, Asefi does teach the porous bioresorbable sheet overlays a truss or is wrapped around a truss (Figs. 5a, 22, 23, 27a; page 4, lines 4-9; page 16, lines 13-25). A plurality of apertures may be provided the bioresorbable sheets along a wall of the channel to permit fluid flow into the channel. The apertures may only be provided in selected portions of the device to selectively drain fluid from or deliver fluid to target areas of the treatment site (Figs 8a, 8b, and 9; page 4, lines 4-13; page 6, lines 33-38).
The truss 2607,3107, 3907 is contained in the conduit structure 2614,3114,3914(Figs. 22, 23,27b, 40c). Asefi teaches when the conduit 3914 is coupled to the truss 3907, the portion of the conduit overlapping with the truss expands to fit over the truss such that the diameter of the conduit is greater in the region where it overlaps with the truss. A plurality of slits 3948 are provided in the wall of the conduit in the coupling region of the conduit to facilitate expansion of the conduit 3914 over the truss. The slits 3948 are useful to facilitate coupling between the oval truss 3907 and a conduit with a different cross-sectional shape, for example a cylindrical conduit. The expanded portion of the conduit applies a compressive force to the truss 3907 to form a secure connection (Figs. 40a - 40c; page 20, line 35 through page 21, line 9). Figure 22 shows the bioresorbable sheet 2619 forms a snug fit around the conduit 2614 where the flexible bioresorbable sheet expands to fit the expanded conduit/truss. It would have been obvious to one having ordinary skill in the art to provide the bioresorbable sheet and conduit with a tight fit since the flexible bioresorbable sheet and resilient conduit expand and contract with the introduction and expansion of the truss (page 21, lines 1-16).
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 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 claim 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).
Asefi does not specifically teach the bioresorbable sheath forms a tight fit with the underlying conduit structure to fluid-permeably seal the conduit structure and prevent or minimize the ingress of solid matter into the conduit structure. However, Asefi does teach the porous bioresorbable sheet overlays a truss or is wrapped around a truss (Figs. 5a, 22, 23, 27a; page 4, lines 4-9; page 16, lines 13-25). A plurality of apertures may be provided the bioresorbable sheets along a wall of the channel to permit fluid flow into the channel. The apertures may only be provided in selected portions of the device to selectively drain fluid from or deliver fluid to target areas of the treatment site (Figs 8a, 8b, and 9; page 4, lines 4-13; page 6, lines 33-38).
The truss 2607,3107, 3907 is contained in the conduit structure 2614,3114,3914(Figs. 22, 23,27b, 40c). Asefi teaches when the conduit 3914 is coupled to the truss 3907, the portion of the conduit overlapping with the truss expands to fit over the truss such that the diameter of the conduit is greater in the region where it overlaps with the truss. A plurality of slits 3948 are provided in the wall of the conduit in the coupling region of the conduit to facilitate expansion of the conduit 3914 over the truss. The slits 3948 are useful to facilitate coupling between the oval truss 3907 and a conduit with a different cross-sectional shape, for example a cylindrical conduit. The expanded portion of the conduit applies a compressive force to the truss 3907 to form a secure connection (Figs. 40a - 40c; page 20, line 35 through page 21, line 9). Figure 22 shows the bioresorbable sheet 2619 forms a snug fit around the conduit 2614 where the flexible bioresorbable sheet expands to fit the expanded conduit/truss. It would have been obvious to one having ordinary skill in the art to provide the bioresorbable sheet and conduit with a tight fit since the flexible bioresorbable sheet and resilient conduit expand and contract with the introduction and expansion of the truss (page 21, lines 1-16).
As to claim 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 59, Asefi teaches 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 63, Asefi teaches parts for the device of claim 43, comprising a conduit structure 2514, 2614, 2114 (Figs. 21, 22, 27a, 27b; page 20 , lines 5-10), 109,209,309,409, (Fig. 4a-5d) defining a fluid removal lumen (Fig. 32), and a bioresorbable sheath (sheet) defining a passage for receipt of the conduit structure (page 4, lines 4-10; Figs. 21-25; page 20, lines 22-24).
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).
Asefi does not specifically teach the bioresorbable sheath forms a tight fit with the underlying conduit structure to fluid-permeably seal the conduit structure and prevent or minimize the ingress of solid matter into the conduit structure. However, Asefi does teach the porous bioresorbable sheet overlays a truss or is wrapped around a truss (Figs. 5a, 22, 23, 27a; page 4, lines 4-9; page 16, lines 13-25). A plurality of apertures may be provided the bioresorbable sheets along a wall of the channel to permit fluid flow into the channel. The apertures may only be provided in selected portions of the device to selectively drain fluid from or deliver fluid to target areas of the treatment site (Figs 8a, 8b, and 9; page 4, lines 4-13; page 6, lines 33-38).
The truss 2607,3107, 3907 is contained in the conduit structure 2614,3114,3914(Figs. 22, 23,27b, 40c). Asefi teaches when the conduit 3914 is coupled to the truss 3907, the portion of the conduit overlapping with the truss expands to fit over the truss such that the diameter of the conduit is greater in the region where it overlaps with the truss. A plurality of slits 3948 are provided in the wall of the conduit in the coupling region of the conduit to facilitate expansion of the conduit 3914 over the truss. The slits 3948 are useful to facilitate coupling between the oval truss 3907 and a conduit with a different cross-sectional shape, for example a cylindrical conduit. The expanded portion of the conduit applies a compressive force to the truss 3907 to form a secure connection (Figs. 40a - 40c; page 20, line 35 through page 21, line 9). Figure 22 shows the bioresorbable sheet 2619 forms a snug fit around the conduit 2614 where the flexible bioresorbable sheet expands to fit the expanded conduit/truss. It would have been obvious to one having ordinary skill in the art to provide the bioresorbable sheet and conduit with a tight fit since the flexible bioresorbable sheet and resilient conduit expand and contract with the introduction and expansion of the truss (page 21, lines 1-16).
The conduit is configured for removal from within the bioresorbable sheath and the treatment site upon completion of treatment (page 20, lines 22-24).
As to claim 66, the fluid removal lumen 3414 has an open end and wherein said open end is surrounded by the porous bioresorbable sheath 3419 (the bioresorbable flexible sheets and 2719, 2819, 2919, 3919, etc. page 16, lines 22-25) – where Asif teaches the device has a reservoir in fluid communication with the conduit 3414 for receiving fluid from the conduit, conduit 3414 is delivering fluid and a separate conduit 3414 is receiving fluid from the device (Figs. 31, 32; page 22, lines 3-12).
As to claim 67, device as claimed in claim 43, wherein the fluid supply lumen, or the fluid removal lumen, or both the fluid supply lumen and the fluid removal lumen, has an open end and wherein said open end is surrounded by the porous bioresorbable sheath 3419 (the bioresorbable flexible sheets and 2719, 2819, 2919, 3919, etc. page 16, lines 22-25). Asif teaches the device has a reservoir in fluid communication with the conduit 3414 for receiving fluid from the conduit, conduit 3414 is delivering fluid and a separate conduit 3414 is receiving fluid from the device (Figs. 31, 32; page 20, lines page 22, lines 3-12).
As to claim 68, the porous bioresorbable sheath comprises a sealing end section proximal the open end of the fluid removal lumen and wherein the sealing end section is free from through-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, line s10-14; page 20, lines page 22, lines 3-34).
As to claim 69, Asif teaches a device as claimed in claim 67, wherein the porous bioresorbable sheath comprises a sealing end section proximal the open end of the fluid supply lumen, or proximal the open end of the fluid removal lumen, or proximal the open ends of the fluid supply lumen and the fluid removal lumen, and wherein the sealing end section is free from through-apertures and having has a tight fit with the underlying portion of the conduit structure 3414 (Figs. 13a, 16a, 22, and 32; page 18, lines 10-14; page 20, lines page 22, lines 3-34).
Claims 5, 6, 11, 44, and 57 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, 44, and 57, 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.
As to claim 11, the apertures in the sheath are provided on upper and lower surfaces of the device (Asif page 16, lines 35-38; Figs. 8a-9).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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.
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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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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