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 .
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 17 December 2025 wherein Claims 1, 3, 4, 10, 12, 13, 16, 22 and 23 are amended, Claim 14 is cancelled, and Claims 27 and 28 are newly added. Therefore, Claims 1, 3, 4, 6 – 8, 10 – 13, 15, 16, 20, and 22 – 28 are currently pending.
The Applicant’s amendment to the Specification dated 17 December 2025 has been fully considered and is entered. The Applicant’s amendment has overcome each Specification Objection set forth in the Non-Final Rejection dated 22 September 2025 (hereinafter referred to as the “Non-Final Rejection”).
The Applicant’s amendments to the Claims dated 17 December 2025 has overcome each Claim Objection set forth in the Non-Final Rejection. Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendment to the Claims dated 17 December 2025 has overcome each Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection. Therefore, each Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 9 – 16, filed 17 December 2025, with respect to the rejection(s) of independent claims 1, 10, and 23 and their respective dependent claims under 35 U.S.C. §§ 102 and 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 Therefore, the rejection has been withdrawn.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 Goode et al. (US 2005/0228346 A1).
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3, 4, 7, 8, 10 – 13, 15, 16, 23 – 25, and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goode et al. (US 2005/0228346 A; hereinafter referred to as “Goode”).
With regards to claim 1, Goode discloses (see Figs. 3 and 4) an apparatus (120) (see [0052] “modular hemostatic valve 120”), comprising: a first body (126); a second body (128); and a rotatable joint (124) that pivotally secures the first body to the second body; wherein in a closed configuration the first body is folded onto the second body via the rotatable joint (see [0053] “a living hinge 124 attaching the first shell 126 and the second shell 128” and Figure 10 which shows a similar closed position for the modular hemostatic valve 120);
a securing feature (130, 132) that maintains the closed configuration (see [0009] and [0053] “The first shell 126 also includes an elongated protrusion 130, and the second shell 128 further includes a coupling hub 132 for capturing the elongated protrusion 130.”);
a catheter sheath feature (see left 134 in Fig. 3 and [0054]) that is part of at least one of the first body and the second body that geometrically locks a catheter sheath (30) (see [0044] “the second medical device can be typically a tubular medical conduit such as a splittable introducer sheath” and [0052] “a second medical device 30”) between the first body and the second body in the closed configuration (see [0054] “The splittable valve body 22 further defines an interfacing region 134 configured to capture the second medical device 30.”), wherein the catheter sheath feature comprises a catheter sheath compartment (see at left 134 and 138 in Fig. 3) having a shape that is a negative of an exterior shape of the catheter sheath (see Fig. 3 and [0054]), and wherein the catheter sheath is geometrically trapped within the catheter sheath compartment without requiring compression by elements extending into the catheter sheath compartment (see Fig. 3, [0054] and at least Figure 10 which shows how the catheter sheath 30 is geometrically trapped within the catheter sheath compartment without requiring compression by element extending into the catheter sheath compartment); and
a catheter feature (see right 134 in Fig. 3 and [0053]) that is part of at least one of the first body and the second body and that frictionally locks a catheter (28) (see [0044] “The first medical device can be typically a catheter” and [0050] “first medical device 28 for placement at the target site”) that extends through a lumen of the catheter sheath between the first body and the second body in the closed configuration (see [0007] “permit passage of a catheter or device therethrough,” [0008] “The valve body may be split open and removed from the introducer sheath, which may also be split apart, leaving the indwelling device undisturbed,” [0044] “first medical device can be typically a catheter…while the second medical device can be typically…a splittable introducer sheath,” and [0052] “facilitate the passage of the first medical device”), wherein the rotatable joint optionally comprises a hinge (see [0053] “a living hinge 124”).
With regards to claim 3, Goode discloses the claimed invention of claim 1, and Goode further discloses (Figs. 3 – 4) wherein in the closed configuration (see [0053] “a living hinge 124 attaching the first shell 126 and the second shell 128” and Figure 10 which shows a similar closed position for the modular hemostatic valve 120) a first body cooperating surface (see Examiner annotated Fig. 3 below; hereinafter referred to as Fig. A) of the first body (126) faces a second body cooperating surface (see Fig. A below) of the second body (128), and wherein the catheter sheath compartment (see at left 134 and 138 in Fig. 3) is disposed in at least one of the first body cooperating surface and the second body cooperating surface (see Fig. 3 which shows the catheter sheath compartment in both the first body cooperating surface and the second body cooperating surface).
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With regards to claim 4, Goode discloses the claimed invention of claim 1, and Goode further discloses (Figs. 3 – 4) wherein in the closed configuration (see [0053] “a living hinge 124 attaching the first shell 126 and the second shell 128” and Figure 10 which shows a similar closed position for the modular hemostatic valve 120) a first body cooperating surface (see Fig. A above) of the first body (126) faces a second body cooperating surface (see Fig. A above) of the second body (128), and wherein the catheter sheath compartment (see at left 134 and 138 in Fig. 3) is distributed between the first body cooperating surface and the second body cooperating surface (see Fig. 3 which shows the catheter sheath compartment being distributed between the first body cooperating surface and the second body cooperating surface).
With regards to claim 7, Goode discloses the claimed invention of claim 1, and Goode further discloses (Figs. 3 – 4) wherein in the closed configuration (see [0053] “a living hinge 124 attaching the first shell 126 and the second shell 128” and Figure 10 which shows a similar closed position for the modular hemostatic valve 120) a first body cooperating surface (see Fig. A above) of the first body (126) faces a second body cooperating surface (see Fig. A above) of the second body (128), and wherein the catheter feature (see right 134 in Fig. 3 and [0053]) comprises a catheter compartment (see Examiner annotated Fig. 3 below; hereinafter referred to as “Fig. B”) in at least one of the first body cooperating surface and the second body cooperating surface in which the catheter is trapped in the closed configuration (see Fig. 3 which shows the catheter compartment in the first body cooperating surface and the second body cooperating surface).
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With regards to claim 8, Goode discloses the claimed invention of claim 1, and Goode further discloses (Figs. 3 – 4) wherein in the closed configuration (see [0053] “a living hinge 124 attaching the first shell 126 and the second shell 128” and Figure 10 which shows a similar closed position for the modular hemostatic valve 120) a first body cooperating surface (see Fig. A above) of the first body (126) faces a second body cooperating surface (see Fig. A above) of the second body (128), and wherein the catheter feature (see right 134 in Fig. 3 and [0053]) comprises a catheter compartment (see Fig. B above) distributed between the first body cooperating surface and the second body cooperating surface in which the catheter is trapped in the closed configuration (see Fig. 3 which shows the catheter compartment distributed between the first body cooperating surface and the second body cooperating surface in which the catheter is trapped in the closed configuration), wherein the catheter compartment optionally comprises a catheter compartment shape that is a negative of a shape of the catheter (see [0053] “a small aperture 134 to facilitate smooth passage of a relatively large-diameter first medical device 28 therethrough” and see Fig. B above).
With regards to claim 27, Goode discloses the claimed invention of claim 1, and Goode further discloses (Figs. 3 – 4) wherein the rotatable joint (124) comprises a hinge (see [0049] “living hinges 124”).
With regards to claim 10, Goode discloses (see Figs. 3 – 4) an apparatus (120) (see [0052] “modular hemostatic valve 120”), comprising:
a first body (126); a second body (128); and a securing arrangement (124, 130, 132) (see [0053]) configured to secure the first body to face the second body in a closed configuration (see [0009], [0053] “The first shell 126 also includes an elongated protrusion 130, and the second shell 128 further includes a coupling hub 132 for capturing the elongated protrusion 130,” and see Figure 10 which shows a similar closed position for the modular hemostatic valve 120);
a catheter sheath feature (see left 134 in Fig. 3 and [0054]) configured to geometrically interlock a catheter sheath (30) (see [0044] “the second medical device can be typically a tubular medical conduit such as a splittable introducer sheath” and [0052] “a second medical device 30”) with at least one of the first body and the second body in the closed configuration (see [0009] and [0053]), wherein the catheter sheath feature comprises a catheter sheath compartment (see at left 134 and 138 in Fig. 3) having a shape that is a negative of an exterior shape of the catheter sheath (see Fig. 3 and [0054]), and wherein the catheter sheath is geometrically trapped within the catheter sheath compartment without requiring compression by elements extending into the catheter sheath compartment (see Fig. 3, [0054] and at least Figure 10 which shows how the catheter sheath 30 is geometrically trapped within the catheter sheath compartment without requiring compression by element extending into the catheter sheath compartment); and
a catheter feature (see right 134 in Fig. 3 and [0053]) configured to frictionally engage a catheter (28) (see [0044] “The first medical device can be typically a catheter” and [0050] “first medical device 28 for placement at the target site”) that extends through a lumen of the catheter sheath with at least one of the first body and the second body in the closed configuration (see [0007] “permit passage of a catheter or device therethrough,” [0008] “The valve body may be split open and removed from the introducer sheath, which may also be split apart, leaving the indwelling device undisturbed,” [0044] “first medical device can be typically a catheter…while the second medical device can be typically…a splittable introducer sheath,” and [0052] “facilitate the passage of the first medical device”).
With regards to claim 11, Goode discloses the claimed invention of claim 10, and Good further discloses (see Figs. 3 – 4) wherein the securing arrangement (124, 130, 132) (see [0053]) comprises:
a rotatable joint (124) that pivotally folds the first body (126) onto the second body (128) in the closed configuration (see [0009] and [0053]); and
a securing feature (130, 132) that maintains the closed configuration (see [0053]).
With regards to claim 12, Goode discloses the claimed invention of claim 10, and Goode further discloses (Figs. 3 – 4) wherein the catheter sheath compartment (see at left 134 and 138 in Fig. 3) is disposed in at least one of the first body (126) and the second body (128) (see Figure 3 which shows the catheter sheath compartment being disposed in both the first body and the second body).
With regards to claim 13, Goode discloses the claimed invention of claim 10, and Goode further discloses (see Figs. 3 – 4) wherein the catheter sheath compartment (see at left 134 and 138 in Fig. 3) is distributed between both the first body (126) and the second body (128) (see Fig. 3 which shows the catheter sheath compartment being distributed between the first and second bodies).
With regards to claim 15, Goode discloses the claimed invention of claim 10, and Goode further discloses (see Figs. 3 – 4) wherein the catheter feature (see right 134 in Fig. 3 and [0053]) comprises a catheter compartment (see at right 134 in Fig. 3) in at least one of the first body (126) and the second body (128) (see Figure 3 which show the catheter feature comprising a catheter compartment in both the first body and second body).
With regards to claim 16, Goode discloses the claimed invention of claim 10, and Goode further discloses (see Figs. 3 – 4) wherein the catheter feature (see right 134 in Fig. 3 and [0053]) comprises a catheter compartment (see at right 134 in Fig. 3) distributed between both the first body (126) and the second body (128) (see Figure 3 which shows the catheter feature being distributed between both the first and second body), wherein the catheter feature comprises a catheter feature shape that comprises a negative of a shape of the catheter (see [0053] “a small aperture 134 to facilitate smooth passage of a relatively large-diameter first medical device 28 therethrough” and see Fig. B above).
With regards to claim 23, Goode discloses (see Figs. 3 – 4) an apparatus (120) (see [0052] “modular hemostatic valve 120”), comprising:
a first body (126) comprising a first body cooperating surface (see Figure A reiterated below); and a second body (128) comprising a second body cooperating surface (see Fig. A reiterated below) that faces the first body cooperating surface when the apparatus is in a closed configuration; and
a securing arrangement (130, 132) (see [0053]) configured to secure the first body to face the second body around a catheter sheath (30) (see [0044] “the second medical device can be typically a tubular medical conduit such as a splittable introducer sheath” and [0052] “a second medical device 30”) and around a catheter (28) (see [0044] “The first medical device can be typically a catheter” and [0050] “first medical device 28 for placement at the target site”) that extends through a lumen of the catheter sheath in the closed configuration (see [0007] “permit passage of a catheter or device therethrough,” [0008] “The valve body may be split open and removed from the introducer sheath, which may also be split apart, leaving the indwelling device undisturbed,” [0044] “first medical device can be typically a catheter…while the second medical device can be typically…a splittable introducer sheath,” and [0052] “facilitate the passage of the first medical device”).;
a catheter sheath feature (see left 134 in Fig. 3 and [0054]) disposed in at least the first body cooperating surface that traps the catheter sheath between the first body and the second body via a geometric interference (see [0009], [0044], and [0053]), wherein the catheter sheath feature comprises a catheter sheath compartment (see at left 134 and 138 in Fig. 3) having a shape that is a negative of an exterior shape of the catheter sheath (see Fig. 3 and [0054]), and wherein the catheter sheath is geometrically trapped within the catheter sheath compartment without requiring compression by elements extending into the catheter sheath compartment (see Fig. 3, [0054] and at least Figure 10 which shows how the catheter sheath 30 is geometrically trapped within the catheter sheath compartment without requiring compression by element extending into the catheter sheath compartment); and
a catheter feature (see right 134 in Fig. 3 and its same location on the first body 126) disposed in at least the first body cooperating surface (see Fig. A reiterated below), wherein in the closed configuration the catheter feature holds the catheter in position via friction but does not occlude the catheter (see [0007], [0008], [0044], and [0052]).
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With regards to claim 24, Goode discloses the claimed invention of claim 23, and Goode further discloses (see Figs. 3 – 4) wherein the catheter sheath feature (see left 134 in Fig. 3 and [0054]) is distributed between the first body cooperating surface (see Fig. A above) and the second body cooperating surface (see Fig. A above) (see Figure 3 which shows the catheter sheath feature being distributed between the first body cooperating surface and the second body cooperating surface).
With regards to claim 25, Goode discloses the claimed invention of claim 23, and Goode further discloses (Figures 3 – 4) wherein the catheter feature (see right 134 in Fig. 3 and [0053]) is distributed between the first body cooperating surface (see Fig. A above) and the second body cooperating surface (see Fig. A above) (see Figure 3 which shows the catheter feature being distributed between the first body cooperating surface and the second body cooperating surface).
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goode in view of Olson et al. (US 2020/0206468 A1 hereinafter referred to as “Olson”).
Olson is cited in the Notice of References Cited form dated 22 September 2025.
With regards to claim 6, Goode discloses the claimed invention of claim 4, and Good further discloses (see Figs. 3 – 4) wherein the shape of the catheter sheath (30) comprises a shape of a hub (137) (see [0055]) of the catheter sheath.
However, Goode is silent with regards to a shape of a side port of the catheter sheath.
Nonetheless Olson, which is within the analogous art of external catheter stabilizers (see abstract and title), teaches (Figs. 12 – 15) wherein the shape of the catheter sheath (20) (see [0067]) comprises a shape of a side port (see at the “inflation port” arrow in Fig. 15) of the catheter sheath.
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 catheter sheath of Goode in view of a teaching of Olson such that the shape of the catheter sheath comprises a shape of a side port of the catheter sheath. Additionally, the shape of the catheter sheath feature would be modified to accommodate the change in shape of the catheter sheath. One of ordinary skill in the art would have been motivated to make this modification because a side port allows for multiple, concurrent uses, such as administering medications, receiving fluids, or taking blood samples without needing to access the patient’s vasculature multiple times. A side port provides a stable, long-term access point, reducing risk of damaging a patient’s vasculature, thereby minimizing a patient’s discomfort. Additionally, Olson teaches that changing the shape of the catheter sheath feature and catheter sheath allows for further stabilization of the catheter sheath and its side port (see Abstract of Olson).
Claim(s) 20 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goode in view of Harris et al. (US 2017/0203079 A1; hereinafter referred to as “Harris”).
Harris is cited in the Notice of References Cited from dated 22 September 2025.
With regards to claim 20, Goode discloses the claimed invention of claim 10, however, Goode is silent with regards to the apparatus further comprising an anchoring feature configured to anchor the apparatus in place on a patient, wherein the anchoring feature optionally comprises an adhesive configured to adhere the apparatus to the patient.
Nonetheless Harris, which is within the analogous art of anchoring features (see [0103]), teaches (Figs. 3 - 31) an anchoring feature (see [0103] “bottom adhesive”) configured to anchor the apparatus in place on a patient (see [0103] and [0104]), wherein the anchoring feature optionally comprises an adhesive configured to adhere the apparatus (see Fig. 28) to the patient (see [0103] “bottom adhesive” and [0104]).
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 apparatus of Goode in view of a teaching of Harris such that the apparatus further comprises an anchoring feature configured to anchor the apparatus in place on a patient, wherein the anchoring feature optionally comprises an adhesive configured to adhere the apparatus to the patient. One of ordinary skill in the art would have been motivated to make this modification in order to secure the apparatus to the patient (see [0103] and [0104] of Harris).
The apparatus of Goode modified in view of a teaching of Harris will hereinafter be referred to as the apparatus of Goode and Harris.
With regards to claim 28, the apparatus of Goode and Harris teaches the claimed invention of claim 20, however, Goode is silent with regards to wherein the anchoring feature comprises an adhesive configured to adhere the apparatus to the patient.
Nonetheless Harris, which is within the analogous art of anchoring features (see [0103]), teaches (Figs. 3 - 31) the anchoring feature (see [0103] “bottom adhesive”) comprises an adhesive (see [0103] “bottom adhesive” and [0104]) configured to adhere the apparatus (see Fig. 28) to the patient.
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 apparatus of Goode and Harris in view of a further teaching of Harris such that the anchoring feature comprises an adhesive configured to adhere the apparatus to the patient. One of ordinary skill in the art would have been motivated to make this modification in order to secure the apparatus to the patient (see [0103] and [0104] of Harris).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goode and Harris as applied to claim 20 above in further view of Erskine (US 4,897,082 A).
Erskine is cited in the Notice of References Cited form dated 22 September 2025.
With regards to claim 22, the apparatus of Goode and Harris teaches the claimed invention of claim 20, however, Goode is silent with regards to wherein the anchoring feature comprises an anchor tab configured to receive a suture that sutures the anchoring feature to the patient.
Nonetheless Erskine, which is within the analogous art of apparatus for providing a suture tab (see abstract and title), teaches (see Fig. 1) the anchoring feature (35) comprises an anchor tab (25) configured to receive a suture that sutures the anchoring feature to the patient (Col. 5, lines 1 – 17 and Fig. 1).
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 anchoring feature (adhesive) taught by the apparatus of Goode and Harris in view of a teaching of Erskine such that the anchoring feature comprises an anchor tab configured to receive a suture that sutures the anchoring feature to the patient. One of ordinary skill in the art would have been motivated to make this modification because Erskine teaches that using tapes, dressings and the like to secure the catheter to the patient causes discomfort to the patient after a period of time due to anhidrosis which is a condition of the skin as a consequence of trapping moisture between the tape and the skin. Similarly, adhesive tapes tend to have less flexibility than the skin and as a result are physically uncomfortable (see Col. 1, lines 56 – Col. 2, line 2 of Erskine).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goode in view of Navarro et al. (US 2007/0043326 A1; hereinafter referred to as “Navarro”).
Navarro is cited in the Notice of References Cited form dated 22 September 2025.
With regards to claim 26, Goode discloses the claimed invention of claim 23, however Goode is silent with regards to wherein at least one of the first body and the second body comprise a material that is transparent, thereby enabling a user to see at least one of the catheter sheath and the catheter in the closed configuration.
Nonetheless Navarro, which is within the analogous art of devices for fixing catheters to the body of a patient (see abstract and title), teaches (see Fig. 1) wherein at least one of the first body (6) and the second body comprise a material that is transparent (see [0065] “the cap 6 can be made of a transparent plastic material”), thereby enabling a user to see at least one of the catheter sheath (see at 13 in Fig. 1) and the catheter (4) in the closed configuration.
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 first body of the apparatus of Goode in view of a teaching of Navarro such that at least one of the first body and the second body comprise a material that is transparent, thereby enabling a user to see at least one of the catheter sheath and the catheter in the closed configuration. One of ordinary skill in the art would have been motivated to make this modification because Navarro teaches that the first body can be made of a transparent material in order to visualize the puncture area of the catheter (see [0065] of Navarro). Making portions of the device to be transparent allows for the surgeon to view the internal components of the device to ensure that everything is properly coupled and operating.
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 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 03/20/2026