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 .
In response to the amendments to the claims filed 08/07/2025 in which claims 1 and 22-23 were amended, claim 25 was cancelled, and claim 26 was added, claims 1-9, 11-17, 22-24, and 26 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/GB2022/050182 filed 01/24/2022 which claims priority to GB/2100877.6 filed on 01/22/2021.
Claims 1-9, 11-17, 22-24, and 26 receive priority to the prior-filed application, filed on 01/22/2021.
Response to Arguments
Objections to the Drawings
The objections to the drawings have been withdrawn in view of the amendments to drawings filed 08/07/2025.
Objections to the Claims
The objections to the claims have been withdrawn in view of the amendments to the claims filed 08/07/2025.
Rejections of the Claims under 35 U.S.C. 112(b)
The rejections of the claims under 35 U.S.C. 112(b) have been withdrawn in view of the amendments to the claims filed 08/07/2025.
Rejections of the Claims under 35 U.S.C. 102 and 103
Applicant's arguments filed 08/07/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments necessitate a new grounds of rejection.
Regarding claim 1, the applicant asserts on pg. 16-17 that the prior art of record do not disclose a constraining sleeve with a closed distal end.
In response to the applicant’s argument, the examiner respectfully notes that the prior art of record were not used in the previous Office Action filed 04/07/2025 to read on the amended limitation.
Regarding claims 22-23, the applicant asserts on pg. 17 that the prior art of record do not disclose a funnel through which the porous element moves into the constraining sleeve.
In response to the applicant’s argument, the examiner respectfully notes that the prior art of record were not used in the previous Office Action filed 04/07/2025 to read on the amended limitations.
The amendments to the claims have necessitated new grounds of rejection.
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 16-17 and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The subject matter of claims 16-17 are directed to an embodiment that is not disclosed for use with the embodiment of amended claim 1. Applicant’s specification pg. 19 ln. 12-30 discloses the embodiment of claim 1 and applicant’s specification pg. 18 and pg. 19 ln. 1-10 discloses the embodiment of claims 16-17. The subject matter of claim 24 is directed to an embodiment that is not disclosed for use with the embodiment of amended claim 23. Applicant’s specification pg. 20-21 discloses the embodiment of claim 23 and applicant’s specification pg. 18 and pg. 19 ln. 1-10 discloses the embodiment of claim 24.
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 1-9 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over US/2021/0260335 A1 to Burke in view of US/2021/0268157 A1 to Ryan.
Regarding claim 1, Burke discloses a vacuum therapy device for treatment of a defect internal of a human or animal body (para. 0022-0023; Fig. 1, 100 vacuum therapy device), the device comprising: a suction tube (Fig. 1, 140 suction tube) extending from: (i) a proximal portion for coupling to a source of negative pressure outside the body (para. 0034; Fig. 1, 146 proximal portion of 140 suction tube coupled to 132 pressure regulator), to (ii) a distal portion for providing suction proximal to the defect when inserted into the body (para. 0058; Fig. 1, 144 distal portion of 140 suction tube); a porous medium coupled to the distal portion of the suction tube to provide suction to the defect when inserted into the body for treatment thereof (para. 0039; para. 0058; Fig. 1, 160 porous medium coupled to 144 distal portion of 140 suction tube); and a constraining sleeve for selective compression of the porous medium (para. 0045; Fig. 1, 150 constraining sleeve; Fig. 2A-2B), the constraining sleeve having a proximal end and a distal end (Fig. 1, 154 distal end of 150 constraining sleeve; Fig. 156 proximal end of 150 constraining sleeve), wherein the proximal end is open (Fig. 2A, open proximal end), and wherein the constraining sleeve is sufficiently rigid to provide the selective compression of the porous medium (para. 0045), wherein the constraining sleeve is movable relative to the porous medium between an insertion position and a treatment position, wherein in the insertion position, the proximal and distal ends of the sleeve are arranged at the distal portion of the suction tube so that the sleeve at least partially surrounds the porous medium to retain the porous medium in a compressed state during insertion into the body (para. 0051-0056; Fig. 2A; Fig. 3 showing 150 constraining sleeve in an insertion position wherein it surrounds 160 porous medium); and in the treatment position, the porous medium is in an expanded state for treatment of the defect (para. 0051-0056; para. 0058; Fig. 2B).
Burke differs from the instantly claimed invention in that Burke fails to disclose wherein the distal end is closed.
Ryan teaches a constraining sleeve comprising a portion that is configured to shrink in response to suction being provided within the sleeve (para. 0037-0040; Fig. 4A-4B showing 34 distal closed membrane portion of 102 constraining sleeve).
Ryan is considered to be analogous to the instantly claimed invention in that Ryan discloses a constraining sleeve for a vacuum therapy device. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the constraining sleeve of Burke to comprise the distal closed membrane portion of Ryan, because Ryan teaches that this configuration allows for the sponge to be loaded into a delivery system with reduced tensile forces, preventing damage to the sponge, and that it enables the sponge to be held in an even smaller diameter compressed form during deployment (para. 0038; Fig. 4A-4B).
Regarding claim 2, the combination of Burke and Ryan discloses the invention of claim 1, the combination further discloses: wherein the constraining sleeve is configured to be inserted through a nasal passageway of a human (Burke: para. 0049).
Regarding claim 3, the combination of Burke and Ryan discloses the invention of claim 2, the combination further discloses: wherein the constraining sleeve is configured to retain the porous medium in its compressed state during insertion of said porous medium and the distal portion of the suction tube through the nasal passageway (Burke: para. 0051-0056; Fig. 2A; Fig. 3 showing 150 constraining sleeve in an insertion position wherein it surrounds 160 porous medium).
Regarding claim 4, the combination of Burke and Ryan discloses the invention of claim 3, the combination further discloses: wherein the device is arranged to enable expansion of the porous medium to its expanded state once the porous medium and distal portion of the suction tube have passed through the nasal passageway (Burke: para. 0051-0056; para. 0058; Fig. 2B).
Regarding claim 5, the combination of Burke and Ryan discloses the invention of claim 4, the combination further discloses: wherein the device is configured to enable the distal portion of the suction tube, the porous medium and the constraining sleeve to be passed out through the human mouth after being inserted through their nasal passageway for movement of the constraining sleeve from the insertion position to the treatment position (Burke: para. 0023; para. 0051-0056).
Regarding claim 6, the combination of Burke and Ryan discloses the invention of claim 1, the combination further discloses: wherein the constraining sleeve comprises a gripping region and/or a gripping element configured to be gripped for movement of the constraining sleeve from the insertion portion to the treatment position (Burke: para. 0041; Fig. 2A-2B, 158 handle).
Regarding claim 7, the combination of Burke and Ryan discloses the invention of claim 6, the combination further discloses: wherein the gripping element of the constraining sleeve comprises a tab (Burke: Fig. 2A-2B, 158 handle as a tab).
Regarding claim 8, the combination of Burke and Ryan discloses the invention of claim 7, the combination further discloses: wherein the tab extends radially outward from the constraining sleeve (Burke: Fig. 2A-2B, 158 handle extending radially outward from 150 constraining sleeve).
Regarding claim 9, the combination of Burke and Ryan discloses the invention of claim 1, the combination further discloses: wherein the porous medium, constraining sleeve, and the distal portion of the suction tube are configured to be inserted into a tube of a nasal insertion applicator and/or an endoscope for placement into the body (Burke: Fig. 1, 110 endoscope comprising 150 constraining sleeve, 140 suction tube, 160 porous medium within working lumen of 120 shaft).
Regarding claim 12, the combination of Burke and Ryan discloses the invention of claim 1, the combination further discloses: wherein the constraining sleeve is small relative to the length of the suction tube (Burke: para. 0031).
Regarding claim 13, the combination of Burke and Ryan discloses the invention of claim 1, the combination further discloses: wherein the constraining sleeve is configured to move distally relative to the suction tube from the insertion position to the treatment position or to be torn away from the porous medium (Ryan: para. 0039).
Regarding claim 14, the combination of Burke and Ryan discloses the invention of claim 1, the combination further discloses: wherein the device is arranged so that movement of the constraining sleeve from the insertion position to the treatment position causes the porous medium to expand into its expanded state for treatment of the defect (Burke: Fig. 2A-2B showing movement of 150 constraining sleeve from insertion position to treatment position allowing for expansion of 160 porous medium).
Regarding claim 15, the combination of Burke and Ryan discloses the invention of claim 1, the combination further discloses: wherein the suction tube comprises a vacuum coupling for connection to a pump to provide suction to the porous medium (Burke: para. 0033-0034; para. 0041; Fig. 1, 132 pressure regulator).
Regarding claim 16, the combination of Burke and Ryan discloses the invention of claim 1, the combination further discloses: wherein the constraining sleeve is configured to shrink in response to suction being provided within the sleeve (Ryan: para. 0037-0040; Fig. 4A-4B showing 34 membrane portion of 102 constraining sleeve).
Regarding claim 17, the combination of Burke and Ryan discloses the invention of claim 16, the combination further discloses: wherein the constraining sleeve is configured to shrink and compress the porous medium into its compressed state when the sleeve surrounds the porous medium and suction is applied to the porous medium by the suction tube (Ryan: para. 0037-0040; Fig. 4A-4B showing 34 membrane portion of 102 constraining sleeve).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Burke and Ryan as applied above, and further in view of WO/2007/106589 A2 to Johnson.
Regarding claim 11, the combination of Burke and Ryan discloses the invention of claim 1; however the combination of the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the constraining sleeve comprises an inner lining configured to reduce friction between the sleeve and the porous medium.
Johnson teaches a constraining sleeve comprising an inner lining configured to reduce friction between the sleeve and a porous medium (Fig. 21 showing 721 constraining sleeve and 761 porous medium; pg. 22 ln. 4-10).
Johnson is considered to be analogous to the instantly claimed invention in that Johnson discloses a vacuum therapy device. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the constraining sleeve of Burke to comprise an inner lining as taught by Johnson, because Johnson teaches that the inner lining of their invention reduces friction (pg. 22 ln. 4-10), which allows for ease of removal of the porous medium.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over US/2021/0260335 A1 to Burke in view of WO/8602826 A1 to Pickhard.
Regarding claim 22, Burke discloses a kit of parts for nasal insertion of a vacuum therapy device into a human or animal body for treatment of a defect in the body (para. 0022-0023; Fig. 1, 100 kit of parts), the kit comprising: a suction tube (Fig. 1, 140 suction tube) extending from: (i) a proximal portion for coupling to a source of negative pressure outside the body (para. 0034; Fig. 1, 146 proximal portion of 140 suction tube coupled to 132 pressure regulator), to (ii) a distal portion for providing suction proximal to the defect when inserted into the body (para. 0058; Fig. 1, 144 distal portion of 140 suction tube); a porous medium couplable to the distal portion of the suction tube to provide suction to the defect when inserted into the body for treatment thereof (para. 0039; para. 0058; Fig. 1, 160 porous medium coupled to 144 distal portion of 140 suction tube); and a constraining sleeve for selective compression of the porous medium (para. 0031; para. 0051-0056; Fig. 2A-B, 150 constraining sleeve for 160 porous medium) configured to be (i) placeable into an insertion position in which proximal and distal ends of the sleeve are arranged at the distal portion of the suction tube with the sleeve at least partially surrounding the porous medium to retain the porous medium in a compressed state during insertion into the body (para. 0031, 150 constraining sleeve may be half the length of 140 suction tube; Fig. 2A, 150 constraining sleeve in place at a distal portion of 140 suction tube around 160 porous medium; para. 0051-0056) and (ii) movable from the insertion position to a treatment position in which the porous medium is in an expanded state for treatment of the defect (para. 0051-0056; Fig. 3 showing placement of 100 kit of parts within body; Fig. 2B, 160 porous medium moved from 150 constraining sleeve into expanded state).
Burke differs from the instantly claimed invention in that Burke fails to disclose a funnel having an inlet providing an inlet cross-sectional area and an outlet providing an outlet cross-sectional area, wherein the outlet cross-sectional area is less than the inlet cross-sectional area, and wherein the outlet cross-sectional area is selected so that movement of the porous element through the funnel from the inlet to the outlet and into the constraining sleeve compresses the porous medium to a size at which it fits into the constraining sleeve.
Pickhard teaches a system for placement of a porous medium within the body (Fig. 4) comprising a funnel having an inlet providing an inlet cross-sectional area and an outlet providing an outlet cross-sectional area, wherein the outlet cross-sectional area is less than the inlet cross-sectional area, and wherein the outlet cross-sectional area is selected so that movement of the porous element through the funnel from the inlet to the outlet and into the constraining sleeve compresses the porous medium to a size at which it fits into the constraining sleeve (Fig. 4, 35 funnel; para. 0079-0081).
Pickhard is considered to be analogous to the instantly claimed invention in that Pickhard discloses a constraining sleeve of a placement system for a porous medium within the body. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the kit of parts of Burke to further comprise a funnel as taught by Pickhard, because Pickhard teaches that providing a funnel for compression of the porous medium allows for ease of compression and positioning of the porous medium in the sheath such that even inexperienced users can achieve a perfect fit of the porous medium (para. 0033).
Regarding claim 23, Burke discloses a method of preparing a vacuum therapy device for treatment of a defect internal to a human or animal body (para. 0022-0023; para. 0051-0056; Fig. 1, 100 vacuum therapy device), the device comprising: (i) a suction tube extending from a proximal portion for coupling to a source of negative pressure outside the body to a distal portion for providing suction proximal to the defect when inserted into the body (Fig. 1, 140 suction tube; para. 0034; Fig. 1, 146 proximal portion of 140 suction tube coupled to 132 pressure regulator; para. 0058; Fig. 1, 144 distal portion of 140 suction tube), and (ii) a porous medium coupled to the distal portion of the suction tube to provide suction to the defect when inserted into the body for treatment thereof (para. 0039; para. 0058; Fig. 1, 160 porous medium coupled to 144 distal portion of 140 suction tube), the method comprising: providing the porous medium in a compressed state within a constraining sleeve with the sleeve in an insertion position in which proximal and distal ends of the sleeve are arranged near the distal portion of the suction tube so that the sleeve at least partially surrounds the porous medium to enable the sleeve to retain the porous medium in the compressed state during insertion into the body (para. 0031; para. 0051-0056; Fig. 2A; Fig. 3 showing 150 constraining sleeve in an insertion position wherein it surrounds 160 porous medium), wherein the constraining sleeve is movable relative to the porous medium between the insertion position and a treatment position in which the porous medium is in an expanded state for treatment of the defect (para. 0051-0056; para. 0058; Fig. 2B).
Burke differs from the instantly claimed invention in that Burke fails to disclose wherein providing the porous medium in the compressed state within the constraining sleeve comprises moving the porous medium through a funnel from a larger cross-sectional area to a smaller cross-sectional area, wherein at the smaller cross-sectional area the porous medium is in its compressed state and it fits within the constraining sleeve.
Pickhard teaches a system for placement of a porous medium within the body (Fig. 4) wherein providing a porous medium in the compressed state within a constraining sleeve comprises moving the porous medium through a funnel from a larger cross-sectional area to a smaller cross-sectional area, wherein at the smaller cross-sectional area the porous medium is in its compressed state and it fits within the constraining sleeve. (Fig. 4, 35 funnel; para. 0079-0081).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the kit of parts of Burke to further comprise a funnel as taught by Pickhard, because Pickhard teaches that providing a funnel for compression of the porous medium allows for ease of compression and positioning of the porous medium in the sheath such that even inexperienced users can achieve a perfect fit of the porous medium (para. 0033).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Burke and Pickhard as applied above, and further in view of US/2021/0268157 A1 to Ryan.
Regarding claim 24, the combination of Burke and Pickhard discloses the method of claim 23; however, the combination of the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein providing the porous medium in the compressed state within the constraining sleeve comprises placing the constraining sleeve over the porous medium and applying suction to the porous medium through the suction tube to shrink the sleeve.
Ryan teaches placing a porous medium within a constraining sleeve comprising a portion that is configured to shrink in response to suction being provided within the sleeve to compress the porous medium (para. 0037-0040; Fig. 4A-4B showing 34 membrane portion of 102 constraining sleeve; Fig. 4A showing uncompressed state of 12 porous medium; Fig. 4B showing compressed state of 12 porous medium).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the constraining sleeve of Burke and Pickhard to further comprise the flexible membrane of Ryan, because Ryan teaches Ryan teaches that this configuration allows for the sponge to be loaded into a delivery system with reduced tensile forces, preventing damage to the sponge (para. 0038).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Burke and Ryan as applied above, and further in view of WO/8602826 A1 to Pickhard.
Regarding claim 26, the combination of Burke and Ryan discloses the invention of claim 1; however, the combination of the prior art differs from the instantly claimed invention in that Burke fails to disclose a funnel having an inlet providing an inlet cross-sectional area and an outlet providing an outlet cross-sectional area, wherein the outlet cross-sectional area is less than the inlet cross-sectional area, and wherein the outlet cross-sectional area is selected so that movement of the porous element through the funnel from the inlet to the outlet and into the constraining sleeve compresses the porous medium to a size at which it fits into the constraining sleeve.
Pickhard teaches a system for placement of a porous medium within the body (Fig. 4) comprising a funnel having an inlet providing an inlet cross-sectional area and an outlet providing an outlet cross-sectional area, wherein the outlet cross-sectional area is less than the inlet cross-sectional area, and wherein the outlet cross-sectional area is selected so that movement of the porous element through the funnel from the inlet to the outlet and into the constraining sleeve compresses the porous medium to a size at which it fits into the constraining sleeve (Fig. 4, 35 funnel; para. 0079-0081).
Pickhard is considered to be analogous to the instantly claimed invention in that Pickhard discloses a constraining sleeve of a placement system for a porous medium within the body. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the kit of parts of Burke and Ryan to further comprise a funnel as taught by Pickhard, because Pickhard teaches that providing a funnel for compression of the porous medium allows for ease of compression and positioning of the porous medium in the sheath such that even inexperienced users can achieve a perfect fit of the porous medium (para. 0033).
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (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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/Linnae E. Raymond/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781