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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3 September 2025 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 3 September 2025 wherein Claim 1 is amended, Claim 4 is cancelled, and Claims 10 – 20 are withdrawn, and no claims are newly added. Therefore, Claims 1 – 3 and 5 – 20 are currently pending within the application wherein Claims 10 – 20 are withdrawn therefrom.
The Applicant’s amendment to the Claims dated 3 September 2025 has overcome the 35 U.S.C. 112(a), (b) and (d) rejections set forth in the Final Rejection dated 4 March 2025. Therefore, each 35 U.S.C. 112(a), (b), and (d) rejection set forth in the Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 5 – 7, filed 3 September 2025, with respect to the rejection(s) of independent claim 1 and its dependent claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ueda et al. (US 2014/0358123 A1), Peterson et al. (US 2014/0128814), Yang et al. (US 2020/0155798 A1), Lockwood (US 5,449,206 A), and Zadno-Azizi et al. (US 5,997,562).
Claim Rejections - 35 USC § 112
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.
Claim(s) 1 – 3 and 5 – 9 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.
Claim 1 recites:
…
a flexible inducer coupled externally to the converter sheath, the flexible inducer comprising:
a ball and socket corrugated outer tube; and
a stiffened inner tube; and
…
Claim 1 is indefinite for failing to particular point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because (1) the metes and bounds for what the term “stiffened” means is undefined and (2) the broadest reasonable interpretation of the ball and socket corrugated outer tube and stiffened inner tube cannot be determined.
Claim 1 recites “a stiffened inner tube.” The metes and bounds of the term “stiffened” is undefined. The specification recites “the flexible inducer 350 is a flexible corrugated outer tube 352 with a flexible but stiffened inner tube 354 (inside the corrugated tube).” The recitation of “flexible but stiffened” creates confusion as to what degree of flexibility is considered to be stiff? A person having skill in the art reading the claims and the specification would not be able to determine what would be considered as flexible or stiff. Therefore, since the claims and specification are not clear as to what is considered to be stiff and flexible the term “stiffened” is indefinite.
Claim 1 recites “the flexible inducer comprising: a ball and socket corrugated outer tube; and a stiffened inner tube.” The broadest reasonable interpretation for the ball and socket corrugated outer tube and the stiffened inner tube cannot be determined based on the claims, specification and drawings. Are these structures two independent tubes or two tubes integral together? Is the stiffened inner tube an inserted sleeve that is located within each ball and socket component? Figure 3B and paragraph [0026] do not clarify the understanding of the claim language. Figure 3B, reproduced below, appears to show the stiffened inner tube 354 to be the lumen of the ball and socket corrugated outer tube 352 because of the reference label’s location, the lack of differentiating shading, and the lack of differentiating cross-hashing for separate components. However, paragraph [0026] recites that “the flexible inducer 350 is a flexible corrugated outer tube 352 with a flexible but stiffened inner tube 354 (inside the corrugated tube).” Does this sentence mean that the stiffened inner tube 354 is a separate tube that is inserted into the flexible corrugated outer tube 352? Since the claims, specification, and drawings do not clarify the claim language the broadest reasonable interpretation of the claim cannot be determined therefore making the claim indefinite.
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Claims 2, 3, and 5 – 9 are rejected under 35 U.S.C. § 112(b) because they are dependent upon rejected Claim 1.
Claim 1 recites
…
a converter sheath with a helical radial curve of 90 degrees over about 2.5 cm to about 13 cm, the converter sheath comprising:
…
Claim 7 recites the following:
The artery catheter adaptor of claim 1, wherein the converter sheath has a length in a range of about 2 cm to about 8 cm.
Claim 7 is indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it cannot be determined how the converter sheath can comprise a helical radial curve of 90 degrees over about 2.5 cm to about 13 cm and a length in a range of about 2 cm to about 8 cm. There appears to be combinations of these ranges that conflict. For example, if the converter sheath has a helical radial curve of 90 degrees over about 2.5 cm then how is it possible that the converter sheath has a length of 2 cm as recited as a possibility within Claim 7.
The Specification does not sufficiently define what the term “about” means to resolve the indefiniteness regarding Claim 7. Paragraph [0020] describes that the term “amount” to be a high degree of variability for example within 10%, 5%, or 1% of the stated value. However, as recited within this paragraph the term “about” is not limited to the example degrees of variability. Therefore, the Examiner requests further clarity regarding the term “about” and what degree of variability the term conveys? How much can a number deviate from the recited numerical value and still be within the “about” language?
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
If the ball and socket corrugated outer tube and stiffened inner tube are two separate, non-integral components (see the 35 U.S.C. § 112(b) rejection above) then these two separate tubes must be shown or the feature(s) canceled from the claim(s).
Figure 3B, reproduced below, is the only figure that shows the ball and socket corrugated outer tube 352 and the stiffened inner tube 354. The stiffened inner tube 354 appears to be labeling the lumen of the ball and socket corrugated outer tube 352 and not a separate, non-integral tube. The drawing does not have different shading, cross-hashing or other feature to differentiate the stiffened inner tube 354 from the ball and socket corrugated outer tube 352. Paragraph [0026] of the specification describes the flexible inducer 350. This paragraph recites that “the flexible inducer 350 is a flexible corrugated outer tube 352 with a flexible but stiffened inner tube 354 (inside the corrugated tube).” Does this sentence mean that the stiffened inner tube 354 is a separate non-integral component of the ball and socket corrugated outer tube 352? If yes, then this structure must be shown. If the stiffened inner tube 354 is the lumen of the ball and socket corrugated outer tube 352 then no drawing amendments are necessary because that is what appears to be already shown.
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No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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(s) 1 – 3, 5, 6, and 8 – 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueda et al. (US 2014/0358123 A1 hereinafter referred to as “Ueda”), Peterson et al. (US 2014/0128814 hereinafter referred to as “Peterson”), Yang et al. (US 2020/0155798 A1 hereinafter referred to as “Yang”), Lockwood (US 5,449,206 A), and Zadno-Azizi et al. (US 5,997,562 hereinafter referred to as “Zadno-Azizi”).
Ueda is cited in the Notice of References Cited form dated 4 March 2025.
Peterson and Zadno-Azizi are cited in the Notice of References Cited form dated 16 September 2024.
With regards to claim 1, Ueda discloses (Figs. 1 – 3) an artery catheter adaptor (22) (see [0090]) comprising:
a hub (48) (see [0111]) for coupling one or more catheters (14, 16) (see [0089])
a converter sheath (46) with a helical radial curve (see Examiner annotated Fig. 3 below hereinafter referred to as Fig. A), the converter sheath comprising:
an artery terminus (50a) (see [0111] “a distal opening 50a (see FIG. 3)”) configured to align with an entry point to an artery (see Fig. 3),
a hub terminus coupled to the hub (see Fig. A below), and
a catheter conduit (50) (see [0111]) between the artery terminus and the hub.
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However, Ueda is silent with regards to:
an immobilizer configured to stabilize the artery catheter adaptor;
the helical radial curve being 90 degrees over about 2.5 cm to about 13 cm
a flexible inducer coupled externally to the converter sheath, the flexible inducer comprising:
a ball and socket corrugated outer tube; and
a stiffened inner tube; and
an interior sheath disposed coaxially and at least partially within the converter sheath, wherein the interior sheath protrudes from the converter sheath at the artery terminus of the adaptor.
Nonetheless Peterson, which is within the analogous art of catheter securement via integrated securement strips (see abstract), teaches (Figs. 1A – 1B) an immobilizer (50; see [0020] “adhesive strip 50 comprises self-adhering adhesive…adhesive strip 50 may comprises a mechanical fastener, such as Velcro®, a snap, a hook and button”) configured to stabilize the artery catheter adaptor (20; see [0017] “a catheter adapter 20”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the artery catheter adaptor of Ueda in view of a teaching of Peterson such that the artery catheter adaptor further comprises an immobilizer configured to stabilize the artery catheter adaptor. One of ordinary skill in the art would have been motivated to make this modification because Peterson teaches the immobilizer maintains a desired position of the catheter adapter following catheterization (see [0018] of Peterson). Therefore, the immobilizer would limit any undesirable movement of the catheter adapter after catheterization.
The artery catheter adaptor of Ueda modified in view of Peterson will hereinafter be referred to as the artery catheter adaptor of Ueda and Peterson.
However, neither Ueda nor Peterson teaches:
the helical radial curve being 90 degrees over about 2.5 cm to about 13 cm;
a flexible inducer coupled externally to the converter sheath, the flexible inducer comprising:
a ball and socket corrugated outer tube; and
a stiffened inner tube; and
an interior sheath disposed coaxially and at least partially within the converter sheath, wherein the interior sheath protrudes from the converter sheath at the artery terminus of the adaptor.
Nonetheless Yang, which is within the analogous art of deflectable catheters (see abstract and title), teaches the helical radial curve being 90 degrees over about 2.5 cm to about 13 cm (see [0043] “In some examples, a degree of curvature of preformed curve segment 430 may be in a range between about 10 degrees to about 180 degree, such as between about 30 degrees and about 140 degrees or between about 43.5 degrees and about 124.1 degrees. In some examples, a length of preformed curve segment 430 defining second curve 431 is within a range between about 6 mm and about 10 cm, such as between about 1 cm and about 5 cm or between about 1 cm and about 2 cm”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the helical radial curve of the artery catheter adaptor of Ueda and Peterson in view of a teaching of Yang such that the helical radial curve is 90 degrees over about 2.5 cm to about 13 cm. One of ordinary skill in the art would have been motivated to make this modification because adjusting the degree of curvature and the length facilitates navigation through tortuous or obstructed anatomy, which enhances safety, improves patient comfort, and increases the successful insertion of medical instruments into the vasculature of the patient.
The artery catheter adaptor of Ueda and Peterson modified in view of a teaching of Yang will hereinafter be referred to as the artery catheter adaptor of Ueda, Peterson, and Yang.
However, none of Ueda, Peterson, or Yang teaches:
a flexible inducer coupled externally to the converter sheath, the flexible inducer comprising:
a ball and socket corrugated outer tube; and
a stiffened inner tube; and
an interior sheath disposed coaxially and at least partially within the converter sheath, wherein the interior sheath protrudes from the converter sheath at the artery terminus of the adaptor.
Nonetheless Lockwood, which is within the analogous art of ball and socket joints for catheters (see abstract and Col. 2, lines 38 – 57) teaches a flexible inducer (10, 18) (see Col. 2, lines 38 – 57) coupled externally to the converter sheath (“catheter” see Col. 2, lines 38 – 57), the flexible inducer comprising:
a ball and socket corrugated outer tube (14, 16) (see Col. 2, lines 38 – 57); and
a stiffened inner tube (62) (Col. 3, lines 48 – 63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the artery catheter adaptor of Ueda, Peterson, and Yang in view of a teaching of Lockwood such that the artery catheter adaptor further comprises a flexible inducer coupled externally to the converter sheath, the flexible inducer comprising: a ball and socket corrugated outer tube; and a stiffened inner tube. One of ordinary skill in the art would have been motivated to make this modification because the flexible inducer limits the pivoting movement of the adjacent ball and socket couplings of the outer tube thereby preventing damage to the converter sheath from excessive bending or stretching at this portion of the converter sheath (see Col. 3, lines 64 – Col. 4, line 24 of Lockwood). A flexible inducer of this configuration allows the clinician to prevent excessive bending or stretching of the converter sheath outside of the patient while still allowing the necessary bending of the converter sheath within the tortuous passageways of the patient.
The artery catheter adaptor of Ueda, Peterson, and Yang modified in view of a teaching of Lockwood will hereinafter be referred to as the artery catheter adaptor of Ueda, Peterson, Yang, and Lockwood. However, none of Ueda, Peterson, Yang, or Lockwood teaches
an interior sheath disposed coaxially and at least partially within the converter sheath, wherein the interior sheath protrudes from the converter sheath at the artery terminus of the adaptor.
Nonetheless Zadno-Azizi, which is within the analogous art of medical protective sheaths (see abstract), teaches an interior sheath (101; see Col. 8, lines 9 – 43 “a protective sheath 101”) disposed coaxially and at least partially within the converter sheath (102; see Col. 8, lines 9 – 43 “a strain relief tubing 102”), wherein the interior sheath protrudes from the artery terminus of the converter sheath (see Fig. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the converter sheath of the artery catheter adaptor of Ueda, Peterson, Yang, and Lockwood in view of a teaching of Zadno-Azizi such that the converter sheath further comprises an interior sheath disposed coaxially and at least partially within the converter sheath, wherein the interior sheath protrudes from the artery terminus of the converter sheath. One of ordinary skill in the art would have been motivated to make this modification because the interior sheath protects a catheter and seals around the catheter preventing fluid flow (see abstract, Col. 3, lines 24 – 40, and Col. 6, line 62 – Col. 7, line 7 of Zadno-Azizi).
The artery catheter adaptor of Ueda, Peterson, Yang and Lockwood modified in view of a teaching of Zadno-Azizi will hereinafter be referred to as the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi.
With regards to claim 2, the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi teaches the claimed invention of claim 1, and Ueda further teaches wherein the artery terminus (50a; see [0111] “a distal opening 50a (see FIG. 3)”) of the converter sheath (46; see [0111]” a flexible tubular sheath 46”) is aligned at an at least one-degree angle from the hub terminus (see Fig. A above) of the converter sheath (see Fig. 3).
With regards to claim 3, the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi teaches the claimed invention of claim 1, and Ueda further teaches wherein the converter sheath (46; see [0111]” a flexible tubular sheath 46”) is configured to contour about a limb (see Fig. 3, abstract, [0088], and [0090]).
With regards to claim 5, the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi teaches the claimed invention of claim 1, however, Ueda is silent with regards to wherein the immobilizer further comprises a hook-and-loop fastener to stabilize the artery catheter adaptor.
Nonetheless, Peterson teaches the immobilizer further comprises a hook-and-loop fastener ([0020] “adhesive strip 50 comprises self-adhering adhesive…adhesive strip 50 may comprises a mechanical fastener, such as Velcro®, a snap, a hook and button”) to stabilize the artery catheter adaptor (20; see [0017] “a catheter adapter 20”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the immobilizer of the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi in view of a further teaching of Peterson such that the immobilizer further comprises a hook-and-loop fastener to stabilize the artery catheter adaptor. One of ordinary skill in the art would have been motivated to make this modification because Peterson teaches the immobilizer maintains a desired position of the catheter adapter following catheterization (see [0018] of Peterson).
With regards to claim 6, the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi teaches the claimed invention of claim 1, and Ueda further teaches (Figs. 1 – 3) wherein the artery is a radial, brachial or femoral artery (200; see [0090] “a sheath introducer 22 (see FIGS. 2 and 3) is inserted into a right radial artery 200”).
With regards to claim 8, the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi teaches the claimed invention of claim 1, however, Ueda is silent with regards to wherein the immobilizer and hub are one unit.
Nonetheless, Peterson which is within the analogous art of catheter securement via integrated securement strips (see Abstract), teaches the immobilizer (52, 54, 100; see [0027] “the top surface 44 of the opposite winged extension 40 comprises an adhesive patch 52 that temporarily retains strap 100 in a folded configuration, prior to use. Strap 100 further comprises a second adhesive patch 54 that further retains strap 100 in a folded configuration, prior to use”) and hub (20; see [0017] “a catheter adapter 20”) are one unit.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to substitute the immobilizer of the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi in view of a further teaching of Peterson such that the immobilizer and hub are one unit. One of ordinary skill in the art would have been motivated to make this modification because Peterson teaches the immobilizer maintains a desired position of the catheter adapter following catheterization (see [0018] of Peterson).
With regards to claim 9, the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi teaches the claimed invention of claim 1, however, Ueda is silent with regards to wherein the immobilizer is an adhesive.
Nonetheless, Peterson which is within the analogous art of catheter securement via integrated securement strips (see Abstract), teaches the immobilizer is an adhesive (52, 54; see [0027] “the top surface 44 of the opposite winged extension 40 comprises an adhesive patch 52 that temporarily retains strap 100 in a folded configuration, prior to use. Strap 100 further comprises a second adhesive patch 54 that further retains strap 100 in a folded configuration, prior to use”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the immobilizer of the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi in view of a further teaching of Peterson such that the immobilizer is an adhesive. One of ordinary skill in the art would have been motivated to make this modification because Peterson teaches the immobilizer maintains a desired position of the catheter adapter following catheterization (see [0018] of Peterson).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi as applied to claim 1 above, and further in view of Adamson (US 2013/0110085 A1).
Adamson is previously cited in the Notice of References Cited form dated September 16, 2024.
With regards to claim 7, the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi teaches the claimed invention of claim 1, however, Ueda is silent with regards to wherein the converter sheath has a length in a range of from about 2 cm to about 8 cm.
Nonetheless, Adamson which is within the analogous art of a catheter with a converter sheath, teaches (Figs. 9 – 11) the converter sheath (40; see [0051] “adjustable length catheter portion 40”) has a length in a range of from about 2 cm to about 8 cm (see [0059] “The adjustable length portions or zones may be a variety of lengths when extended, such as about…8 cm, about 7 cm, about 6 cm, about 5 cm, about 3 cm, about 2 cm”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the length of the converter sheath of the artery catheter adaptor of Ueda, Peterson, Yang, Lockwood, and Zadno-Azizi in view of a teaching of Adamson such that the converter sheath has a length in a range of from about 2 cm to about 8 cm. One of ordinary skill in the art would have been motivated to make this modification, because Ueda is silent with regards to the length of the converter sheath, and Adamson teaches a range of lengths that the catheter/converter sheath may be while achieving advantageous results (see [0059] of Adamson). Adamson teaches that the length and shape of a plurality of circumferential corrugations allow the catheter/converter sheath to be shortened by decreasing the distance between the ridges or lengthened by increasing the distance between ridges (see [0044] of Adamson). The shortening and lengthening of the catheter/converter sheath provides the user with the ability to directly manipulate the catheter/converter sheath to the desired shape and size (see [0012] of Adamson).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following prior art teaches a ball and socket corrugated outer tube:
Perry (US 2010/0069715 A1).
Christianson (US 2003/0184086 A1)
Vargas et al. (US 2008/0091170 A1)
Kuniyasu (US 2015/0011977 A1) cited within the notice of references cited form dated 16 September 2024.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 12/26/2025