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 Invention I, claims 1-12, 21-28, in the reply filed on July 10, 2026 is acknowledged.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Loske (US 2023/0012427), disclosed in the IDS of January 3, 2025, and as evidenced by Cotton (US 2014/0309574).
Regarding claim 1, Loske discloses a device for treating a wound in an endoluminal space of a patient (see Figs. 1-7, 18-20, 38), the device comprising: an elongate tube 8 defining a proximal end, a distal end, and a lumen (see Figs. 6-7); an expandable component 10 (see par. 14, 89 and Figs. 1-7, sponge goes from compressed to expanded) adjustably positioned at the distal end of the elongate tube between a delivery position within the elongate tube and a fully deployed position at least partially exterior of the elongate tube (see Figs. 1-7), wherein the expandable component is absorbent (see par. 14, 20, 33 open pored polyurethane sponge and open cell polyurethane foam, interpreted as sponge, is absorbent, as disclosed by Cotton in paragraph 91); and a tether 3 coupled to the expandable component (see Figs. 1-2, 6) and extending proximally from the expandable component through the lumen to a location exterior of the elongate tube (see Figs. 1, 6).
Regarding claim 2, Loske discloses the expandable component 10 is adjustable to a partially deployed position (see Fig. 2) having a desired volume between a first volume when the expandable component is in the delivery position (see Fig. 1) and a second volume when the expandable component is in the fully deployed position (see Figs. 4-6).
Regarding claim 3, Loske discloses the elongate tube 8 is an elongate outer tube (see Figs. 2-4, 6) and the device further comprises: an elongate inner member 7 configured to extend into the lumen of the elongate outer tube and having a proximal end exterior of the elongate outer tube (see Figs. 2-4, 6).
Regarding claim 4, Loske discloses the elongate inner member 7 is configured to engage a proximal portion of the expandable component to adjust a volume of the expandable component deployed from the distal end of the elongate outer tube (see Figs. 1-4).
Regarding claim 5, Loske discloses the elongate inner member 7 is an elongate inner tube defining a lumen and the tether 3 extends through the lumen of the elongate inner tube to a location exterior of the elongate inner tube (see Fig. 6).
Regarding claim 6, Loske discloses a distal end of the tether is coupled to the expandable component at a location of the expandable component distal of the distal end of the elongate tube when the expandable component is in the fully deployed position (see Fig. 6).
Regarding claim 10, Loske discloses one or more cavities within the expandable component (see par. 14 describing open cells, which can be interpreted as cavities and Fig. 6, which shows a cavity).
Regarding claim 11, Loske discloses the expandable component is a sponge (see par. 89).
Regarding claim 12, Loske discloses the expandable component is configured to be wrung-out when it is positioned within the elongate tube (see Figs. 1-3).
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loske as applied to claim 1 above, and further in view of To et al. (US 2005/0273138).
Regarding claim 9, Loske discloses limitations of claim 1 but does not specifically teach a lubricious layer at a location of an outer surface of the expandable component configured to contact the distal end of the elongate tube when the expandable component adjusts between the delivery position and the fully deployed position.
To discloses an elongate shaft/tube 204 through which a part 210 is deployed (see par. 100) within a body during an operation (see Abstract), the part including a lubricious coating to help minimize friction when deploying the part (see par. 65). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the expandable component, which is also deployed through an elongate tube, to include a lubricious coating to help minimize friction during deployment, as disclosed by To.
Claim(s) 21-22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loske.
Regarding claim 21, Loske discloses device for treating a wound in an endoluminal space of a patient (see Figs. 1-7, 18-20, 38), the device comprising: an outer tube 8 defining a lumen and including a distal containment portion (see Figs. 1-3); an expandable component 10, the expandable component (see par. 14, 89 and Figs. 1-7, sponge goes from compressed to expanded) being positionable in a delivery configuration and a deployed configuration (see Figs. 1-7); an inner member 7 extending through the lumen of the outer tube and configured to engage the expandable component to advance the expandable component distally out of the distal containment portion (see Figs. 1-7); and a tether 3 coupled to the expandable component and extending proximally from the expandable component through the lumen of the outer tube (see Figs. 1-3), wherein a front portion of the sponge is biased to expand radially outward as the inner member advances the front portion distally out of the distal containment portion (see Figs. 2-3).
Loske does not specifically teach in the embodiment described above, the expandable component including a stem portion and a cap portion; the expandable component being positionable in a delivery configuration in which the cap portion is contained within the distal containment portion and a deployed configuration in which the cap portion is positioned exterior of the distal containment portion; an inner member 7 extending through the lumen of the outer tube and configured to engage the stem portion of the expandable component to advance the cap portion distally out of the distal containment portion; wherein the cap portion is biased to expand radially outward as the inner member advances the cap portion distally out of the distal containment portion.
Loske discloses a different embodiment of the expandable component that includes a cap portion (see Figs. 18-20, par. 111, cap portion is top portion) and a stem portion (see Figs. 18-20, par. 111, stem portion is the trunk below the cap portion that surrounds drainage tube 20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the sponge of Figure 1 of Loske with that of Figure 20, Loske disclosing such an alternative and this predictably resulting in the required expandable component that collects fluid as a sponge. Due to the position of the cap portion and the stem portion, the expandable component would then be positionable in a delivery configuration in which the cap portion is contained within the distal containment portion, like in Figure 1 of Loske, and a deployed position configuration in which the cap portion is positioned exterior of the distal containment portion, similar to Figures 4-6 of Loske; the inner member would be configured to engage the stem portion of the expandable component to advance the cap portion distally out of the distal containment portion, similar to in Figures 2-3 of Loske, and the cap portion would be biased to expand radially outward as the inner member advances the cap portion distally out of the distal containment portion, similar to in Figures 2-6 of Loske. Loske discloses a different embodiment of the expandable component that includes a cap portion (see Figs. 18-20, par. 111, cap portion is top portion) and a stem portion (see Figs. 18-20, par. 111, stem portion is the trunk below the cap portion that surrounds drainage tube 20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the sponge of Figure 1 of Loske with that of Figure 20, Loske disclosing such an alternative and this predictably resulting in the required expandable component that collects fluid as a sponge.
Regarding claim 22, Loske discloses the limitations of claim 21 and Loske further discloses the cap portion defines a distal-facing opening when the expandable component is in the delivery configuration (see Figs. 1, 7, cap would be at most distal portion of sponge 10, which includes a distal-facing opening for tether 3).
Regarding claim 24, Loske discloses the limitations of claim 21 and further discloses the cap portion includes at least one cavity configured to radially expand as the cap portion advances out of the distal containment portion (see par. 14, 20, 33 open pored polyurethane sponge, pores interpreted as cavities which expand when the sponge, including the cap portion, goes from the delivery to deployed configurations).
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loske as applied to claim 21 above, and further in view of Leeds (US 2020/0276056), disclosed in the IDS of January 3, 2025.
Regarding claim 25, Loske discloses limitations of claim 21 but does not teach the tether is coupled to an anchor positioned at a distal end of the expandable component.
Leeds discloses a negative pressure therapy unit with for treating internal wounds (see Abstract) comprising an expandable component 109 (see Figs. 8-9) and a tether 121, the tether coupled to an anchor 123 positioned at a distal end of the expandable component (see par. 35), the anchor helping to determine the correct position (see par. 35). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further include an anchor as disclosed by Leeds in order to help determine the correct position.
Regarding claim 26, Loske and Leeds disclose the limitations of claim 25 and further disclose the anchor is positioned distal of a distal end of the outer tube when the expandable component is in the deployed configuration (see Loske, Figure 6 and teachings of Leeds described in the rejection of claim 25 above having the anchor adjacent to distal end of expandable component, which would make the anchor positioned distal of the outer tube).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loske as applied to claim 21 above, and further in view of Lestoquoy (US 2018/0353197).
Regarding claim 27, Loske discloses the limitations of claim 21 but does not disclose the distal containment portion includes a first portion tapering proximally toward a core portion of the outer tube and a second portion extending distally from the first portion.
Lestoquoy discloses an outer tube 10 (see Fig. 1) defining a lumen (see Fig. 1) that includes a distal containment portion (see Fig. 1), the distal containment portion including a first portion tapering proximally toward a core portion of the outer tube (see Fig. 1, taper near distal end 14), and a second portion extending distally from the first portion (see Fig. 1, non-tapering portion after taper at distal end 14), such a configuration helping to facilitate reintroduction of a compressible member 20 to ensure its progressive compression (see par. 84). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the distal containment portion include first and second portions as disclosed by Lestoquoy in order to help facilitate reintroduction of the expandable component to ensure its progressive compression to help with removal from the body when the device is not longer needed in the body.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loske as applied to claim 21 above, and further in view of Miyake et al. (WO 2021/075230). Citations of Miyake are to the document provided with this office action.
Regarding claim 28, Loske discloses limitations of claim 21 but does not disclose the outer tube includes an intermediate port positioned between a proximal end and a distal end of the outer tube, and wherein the inner member and the tether extend through the intermediate port.
Miyake discloses an outer tube 5 defining a lumen and including a distal containment portion (see Figs. 1, 2), a tether 60 and an expandable component 22 pushed forward through shaft 21 (see Figs. 1-2), interpreted as an inner member, the outer tube includes an intermediate port 52 positioned between a proximal end and a distal end of the outer tube, wherein the inner member and the tether extend through the intermediate port (see Fig. 1) allowing for branched sections, one branch 55 for control of negative pressure and the other for control of operating movement of parts within the tube (see Fig. 1, page 13). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute the setup of the outer tube of Loske with that of Miyake in having an intermediate port positioned between a proximal end and a distal end of the outer tube, and the inner member and the tether extend through the intermediate port, as this predictably would result in a section allowing for negative pressure and a section allowing for control of the tether and inner member for deployment of the expandable component and therefore treatment of a wound in an endoluminal space of a patient.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Loske, which does not disclose the required expandable component being configured to evert as it transitions between the delivery position and the fully deployed position. While Greenhalgh (US 2023/0241303), disclosed in the IDS of January 3, 2025, discloses a negative pressure surgical drain with an expandable component 107 configured to evert as it transitions between the delivery position and the fully deployed position, the expandable component is made of mesh and expands by an elongate tube that pushes on the mesh such that its length is shortened, allowing for the width of the mesh to expand (see Figs. 1A-1B), and therefore is not positioned within the elongate tube and deployed at least partially exterior of the elongate tube, and therefore has a different method of deploying and expanding. In Loske, the expandable component is foam while in Greenhalgh, the expandable component is mesh and due to such different materials and manner of expansion in the configuration of parts in the materials, one of ordinary skill in the art would not be motivated to modify the expandable component of Loske such that it is configured to evert as claimed.
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Loske discloses the limitations of claim 1 but in the specific embodiment discussed above does not disclose the expandable component includes a stem portion and a cap portion and the elongate tube is configured to extend between the stem portion and the cap portion of the expandable component when the expandable component is in the fully deployed position.
Loske discloses a different embodiment of the expandable component that includes a cap portion (see Figs. 18-20, par. 111, cap portion is top portion) and a stem portion (see Figs. 18-20, par. 111, stem portion is the trunk below the cap portion that surrounds drainage tube 20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the sponge of Figure 1 of Loske with that of Figure 20, Loske disclosing such an alternative and this predictably resulting in the required expandable component that collects fluid as a sponge. However, the elongate tube would not be configured to extend between the stem portion and the cap portion of the expandable component when the expandable component is in the fully deployed position, as it would be below the stem portion, on the opposite side of the stem from the cap portion. No prior art could be found to address the deficiency of teachings of Loske.
In applicant’s invention, the eversion capability of the expandable component allows the elongate tube to extend between the stem portion and the cap portion when the expandable component is in the fully deployed position (see Figure 4C of the current application).
Additionally, while the written opinion of the international searching authority for PCT/US2024/040512 discusses Burke et al. (US 2021/0260335) disclosing claim 8, both the written opinion and Burke disclosed in the January 3, 2025 IDS submitted by applicant, the written opinion cites Figure 4a, which does not disclose the expandable component adjustably positioned at the distal end of the elongate tube between a delivery position within the elongate tube and a fully deployed position at least partially exterior of the elongate tube, as the expandable component is always located outside the elongate tube, with the elongate tube pushing on the expandable component and expanding the expandable component by shortening its length and increasing its width (see Figs. 4A-4B). Such a position within the elongate tube is required by claim 1 and consequently, if Figures 4A-4B do not disclose claim 1, they cannot disclose claim 8 due to its dependency from claim 1.
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Loske, which does not disclose the required cap portion being configured to evert as the cap portion advances from the delivery configuration to the deployed configuration. While Greenhalgh (US 2023/0241303), disclosed in the IDS of January 3, 2025, discloses a negative pressure surgical drain with an expandable component 107 configured to evert as it transitions between the delivery position and the fully deployed position, the expandable component is made of mesh and expands by an elongate tube that pushes on the mesh such that its length is shortened, allowing for the width of the mesh to expand (see Figs. 1A-1B), and therefore is not positioned within the elongate tube and deployed at least partially exterior of the elongate tube, and therefore has a different method of deploying and expanding. In Loske, the expandable component is foam while in Greenhalgh, the expandable component is mesh and due to such different materials and manner of expansion in the configuration of parts in the materials, one of ordinary skill in the art would not be motivated to modify the expandable component of Loske such that it is configured to evert as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Patel et al. (US 2020/0330660), disclosing an elongate tube 1, a sponge 2, and a tether 6.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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