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 .
Priority
The instant application is a 371 of PCT/US2022/023663 filed 04/06/2022 which claims priority to U.S. Provisional App. no. 63/171,343 filed on 04/06/2021.
Claims 1-20 receive priority to the prior-filed application, filed on 04/06/2021.
Election/Restriction
Applicant's election of Species A1 and B1 in the reply filed on 12/17/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Upon reconsideration of the species elections, the examiner withdraws the requirement for election of Species B.
Applicant’s species election is allegedly drawn to claims 1-4 and 6-20. The examiner additionally notes that claims 7-8 (Species AII: Fig. 12A-C), 9-10 (Species AIII: Fig. 13A-D), and 14-15 (Species AIV: Fig. 14A-C) are directed to non-elected species are therefore withdrawn.
Claims 7-10, and 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/10/2025.
Claims 1-20 are pending in the instant application and in light of the response to restriction in which claims 7-10, and 14-15 were withdrawn, claims 1-6, 11-13, and 16-20 are examined on the merits herein.
Specification
The disclosure is objected to because of the following informalities:
The lumen is referred to by an incorrect reference number (para. 0069 ln. 10).
The sponge element is referred to by an incorrect reference number (para. 0071 ln. 4).
The sponge cone is referred to by an incorrect reference number (para. 0082 ln. 6).
Appropriate correction is required.
Claim Objections
Claim 6 is objected to because of the following informalities: Claim 6 recites the limitation “when that the sponge element” in ln. 6. This should read “when the sponge element”.
Appropriate correction is required.
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 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)(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.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US/2021/0260335 A1 to Burke.
Regarding claim 1, Burke discloses a deployable sponge system (Fig. 1) comprising:
a lumen including a proximal end and a distal end positioned opposite the proximal end (Fig. 2A, lumen 150 including proximal end 156 and distal end 154);
a catheter movably mounted in the lumen (Fig. 2A, catheter 140 movably mounted in lumen 150), wherein the lumen is flexible and hollow (para. 0032); and
a sponge element mounted on a distal end of the catheter and configured to fit in the lumen and movable with the catheter in the lumen from a retracted position in the lumen to an extended position in which the sponge element extends beyond the distal end of the lumen (Fig. 2A-2B, sponge element 160; para. 0037-0039);
wherein the catheter includes at least one distal opening formed in the distal end thereof and configured to allow fluid to flow from the sponge element into the catheter (Fig. 2A-2B, distal openings 143 in catheter 140; para. 0044).
Regarding claim 2, Burke discloses the invention of claim 1. Burke further discloses a flange formed on the lumen between the proximal end and the distal end (Fig. 2A-2B, lumen 150 comprising flange 158 between proximal-most end 156 and distal end 154) and configured to secure the lumen to the body of a patient (para. 0049-0055, flange 158 is fully capable of being in contact with and securing the lumen outside of the body of a patient through an increased diameter while catheter 140 is moved to deploy sponge element 160).
Regarding claim 4, Burke discloses the invention of claim 1. Burke further discloses wherein the lumen is substantially straight (Fig. 2A-2B showing lumen 150 as substantially straight).
Regarding claim 5, Burke discloses the invention of claim 1. Burke further discloses wherein the lumen is bent in at least one direction along its length (para. 0032, lumen 150 is flexible such that it can bend, rotate, and/or twist).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Burke as applied above, and further in view of WO/8602826 A1 to Pickhard.
Regarding claim 3, Burke discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that Burke fails to disclose wherein a diameter of the proximal end of the lumen is larger than a distal diameter of the distal end of the lumen.
Pickhard teaches a sponge deployment system (Fig. 4) comprising a lumen wherein a diameter of the proximal end of the lumen is larger than a distal diameter of the distal end of the lumen (Fig. 4, combined lumen of 35/36 comprises a proximal end diameter 38 which is larger than distal diameter 39 and diameter at conical surface distal end 42).
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 lumen of Burke to comprise a larger proximal diameter than a distal diameter as taught by Pickhard, because Pickhard teaches that compressing the sponge using a funnel and positioning the sponge using the guide tube in the sheath allows even inexperienced users to achieve a perfect fit of the sponge (para. 0033).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Burke as applied above, and further in view of U.S. Patent no. 8,721,520 B2 to Caira.
Regarding claim 6, Burke discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that Burke fails to disclose a first movable element provided at the distal end of the lumen; and a second movable element provided at the distal end of the lumen: wherein the first movable element is movable relative to the second movable element and the second movable element is movable relative to the first movable element when that the sponge element passes between the first movable element and the second movable element to the extended position.
Caira teaches an expandable implant delivery system (para. 0003; para. 0100) comprising a first movable element provided at the distal end of the lumen; and a second movable element provided at the distal end of the lumen: wherein the first movable element is movable relative to the second movable element and the second movable element is movable relative to the first movable element when that the sponge element passes between the first movable element and the second movable element to the extended position (Fig. 14A-14B, first and second rounded movable elements at a distal end of lumen 8 movable relative to each other to allow for expandable element to pass through; para. 0168).
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 lumen of Burke to comprise the first and second movable elements of Caira, because Caira teaches that the movable elements facilitate the expansion or expulsion of the expandable implant within the body (para. 0168) and that providing the movable elements as a rounded atraumatic tip prevents trauma which could possibly be provided by an open end of the lumen (para. 0150).
Claims 11-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Burke as applied above, and further in view of U.S. Patent no. 5,339,828 A to Keating.
Regarding claims 11-13, Burke discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that Burke fails to disclose
(Claim 11) wherein the catheter further comprises a blocker element extending outward from an outer wall of the catheter and having a blocker diameter larger than the proximal diameter of the proximal end of the lumen such that the blocker element limits movement of the catheter and sponge element into the lumen;
(Claim 12) wherein the blocker element is positioned on the catheter to set a maximum extended position of the sponge element and the catheter; and
(Claim 13) a fastening element configured to releasably secure the blocker element to the catheter such that the position of the blocker element on the catheter is adjustable.
Keating teaches an absorbent swab deployment system (Fig. 4)
(Claim 11) wherein a catheter further comprises a blocker element extending outward from an outer wall of the catheter and having a blocker diameter larger than the proximal diameter of a proximal end of a lumen such that the blocker element limits movement of the catheter and absorbent element into the lumen (Fig. 4, catheter 10 comprising removable blocking element 58 and blocking element 62 extending outward from outer wall of catheter 10 and having a diameter larger than a proximal end of cannula 20; col. 6 ln. 33-68; col. 7 ln. 62-68 and col. 8 ln. 1-27);
(Claim 12) wherein the blocker element is positioned on the catheter to set a maximum extended position of the sponge element and the catheter (Fig. 4-7, catheter 10 comprising removable blocking element 58 and blocking element 62 extending outward from outer wall of catheter 10 and having a diameter larger than a proximal end of cannula 20; col. 6 ln. 33-68; col. 7 ln. 62-68 and col. 8 ln. 1-27); and
(Claim 13) a fastening element configured to releasably secure the blocker element to the catheter such that the position of the blocker element on the catheter is adjustable (Fig. 4-7, catheter 10 comprising removable blocking element 58 and blocking element 62 extending outward from outer wall of catheter 10 and having a diameter larger than a proximal end of cannula 20; col. 6 ln. 33-68; col. 7 ln. 62-68 and col. 8 ln. 1-27; removable blocking element 58 must comprise some fastening element to allow it to be releasably secured to catheter 10).
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 catheter of Burke to comprise a blocker element as taught by Keating, because Keating teaches that blocking elements can permit a catheter to pass only a predetermined distance into a body cavity and can allow for maneuvering of the catheter through the lumen without the danger of losing the catheter and absorbent swab elements within the body cavity (col. 6 ln. 33-68; col. 7 ln. 7-22).
Regarding claims 16-17, Burke discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that Burke fails to disclose
(Claim 16) wherein the catheter further comprises a sponge cone positioned adjacent to a proximal portion of the sponge element and configured to seal the proximal end of the lumen to prevent fluid from flowing into the lumen when the sponge element and catheter are in the extended position; and
(Claim 17) wherein the sponge cone is flexible and flexes to allow the sponge element to retract into the lumen.
Keating teaches an absorbent swab deployment system (Fig. 4)
(Claim 16) wherein the catheter further comprises a sponge cone positioned adjacent to a proximal portion of the absorbent swab element and configured to seal the proximal end of the lumen to prevent fluid from flowing into the lumen when the sponge element and catheter are in the extended position (Fig. 4-7, stopper 52 as a cone positioned adjacent to absorbent swab element 12 and configured to seal proximal end of the lumen to prevent fluid from flowing beyond stopper 52 into cannula 20; col. 5 ln. 40-53, 65-68 and col. 6 ln. 1-4); and
(Claim 17) wherein the sponge cone is flexible and flexes to allow the absorbent swab element to retract into the lumen (Fig. 4-7, stopper 52 as a cone positioned adjacent to absorbent swab element 12 and configured to seal proximal end of the lumen to prevent fluid from flowing beyond stopper 52 into cannula 20; col. 5 ln. 40-53, 65-68 and col. 6 ln. 1-4).
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 catheter of Burke to comprise a sponge cone as taught by Keating, because Keating teaches that the stopper of their invention provides a seal to stop gas, blood, and other bodily fluids in the body cavity from rushing over and past the absorbent element (col. 1 ln. 40-54), such that they may not leak from the body cavity.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burke as applied above, and further in view of US/2021/0268157 A1 to Ryan.
Regarding claims 18-19, Burke discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that Burke fails to disclose
(Claim 18) a sponge housing surrounding the sponge element, wherein the sponge housing compresses the sponge element to pass into the proximal end of the lumen; and
(Claim 19) wherein the sponge housing is configured to pass at least partially into the proximal end of the lumen and the sponge housing separates from the sponge element as the sponge element advances to the extended position.
Ryan teaches a sponge deployment system (Fig. 1) comprising
(Claim 18) a sponge housing surrounding a sponge element, wherein the sponge housing compresses the sponge element to pass into the proximal end of the lumen (Fig. 3, netting 24 as sponge housing surrounding sponge 12; para. 0032); and
(Claim 19) wherein the sponge housing is configured to pass at least partially into the proximal end of the lumen and the sponge housing separates from the sponge element as the sponge element advances to the extended position (para. 0034).
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 sponge of Burke to further comprise a sponge housing as taught by Ryan, because Ryan teaches that providing the sponge in a compressed state by the sponge housing makes the sponge more easily deliverable through a working channel and through a natural body lumen of a subject (para. 0022).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Burke as applied above, and further in view of U.S. Patent no. 9,603,753 B2 to Ihde.
Regarding claim 20, Burke discloses the invention of claim 1; however, the prior art differs from the instantly claimed invention in that Burke fails to disclose wherein the catheter further comprises at least one marking provided on a sidewall thereof indicating a position of the sponge element relative to the lumen.
Ihde teaches a sponge deployment system comprising a tube that comprises at least one marking on a sidewall thereof indicating a position of the sponge element relative to a lumen (Fig. 1, marker 104 on tube 100; col. 5 ln. 49-67 and col. 6 ln. 1-9).
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 catheter of Burke to further comprise a marking as taught by Ihde, because Ihde teaches that providing a marker can be used to indicate an insertion distance with respect to a cannula and can further be utilized to indicate to a user an optimal insertion distance (col. 5 ln. 49-67 and col. 6 ln. 1-9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent no. 11,992,600 B1 to Newkirk discloses a sponge catheter. US/2023/0372602 A1 to Folan discloses a sponge deployment system comprising moveable elements at the distal end of the lumen. US/2022/047270 A1 to Kim discloses an implant deployment system comprising an expandable distal end of the lumen and a piston seal behind the implant.
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 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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/Linnae E. Raymond/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781