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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/30/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, the same information disclosure statement also fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Specifically, foreign patent documents: DE 102014016111 and WO 2026064669. Further, multiple errors were found in the IDS, such as, incorrect “Name of Patentee or Applicant of cited Document,” the same reference cited twice (i.e., WO 2021148490), number of pages of a cited NPL reference, and/or incorrect citation of reference (i.e., European Application No. 23747808.6 cited in the NPL documents section of the IDS). The IDS has been annotated to indicate and highlight these discrepancies.
Response to Amendment
Acknowledgment is made to Applicant's amendments filed on 04/30/2026. With regards to the specification and claim objections documented in the Non-Final Office Action sent on 01/30/2026, they’re overcome through Applicant’s amendments and are withdrawn.
Claims 1-8 and 20-24 remain withdrawn. Claims 9-12, 14-19, and 25-33 are amended. Claim 13 is canceled. A complete action on the merits of pending claims 9-12, 14-19, and 25-33 appears below.
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.
Claims 10-11 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.
Regarding claim 10, the phrase "the first body region has a first stiffness and the second body region has a second stiffness, wherein the first stiffness is greater than the second stiffness" renders the claim indefinite because claim 9, from which claim 10 depends, requires the first body region to be more flexible than the second body region and it is not possible for the first body region to be both more flexible and at the same time be more stiff than the second body region as “flexibility” and “stiffness” are inverse characteristics of each other, therefore, it is unclear if Applicant is intending for the first body region to be more flexible and less stiff than the second body region or if Applicant is intending for first body region to be less flexible and more stiff than the second body region.
Regarding claim 11, the phrase "the first body region has a first durometer and the second body region has a second durometer, wherein the second durometer is less than the first durometer" renders the claim indefinite because claim 9, from which claim 11 depends, requires the first body region to be more flexible than the second body region and it is not possible for the first body region to have a higher flexibility than the second body region and have a higher durometer than the second region because “flexibility” and “durometer” are inverse characteristics of each other, therefore, it is unclear if Applicant is intending for the first body region to be more flexible and have a lower durometer than the second body region or if Applicant is intending for first body region to be less flexible and have a lower durometer than the second body region.
The specification consistently discloses the opposite relationship (see, e.g., Paragraphs [0013], [0029], and the corresponding Examples (Paragraph [0046]; Examples 1 and 32)) of what is recited in claim 9. The specification does not explicitly describe a second body region that is less flexible than the first body region; Paragraph [0029], broadly states, “Each of the body regions 244 can have one or more respective mechanical properties, such as a hardness, stiffness, durometer, flexibility, rigidity, Young’s modulus, density, and/or the like. The mechanical properties (e.g., varying durometer) can give the body regions 244 different flexibility profiles.” Because claim 9 and its dependent claims set forth mutually exclusive requirements for the relative flexibility profiles of the first and second body regions, a person of ordinary skill in the art cannot ascertain the metes and bounds of the claimed invention with reasonable certainty.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 9, 12, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korkuch (US 2021/0236783 A1), in view of Cope (US 5,499,975 A), and further in view of Merritt (US 2019/0070401 A1).
Regarding claim 9, Korkuch discloses, an expandable introducer sheath with an interlock dilator. Korkuch teaches, a vascular access system (Figures 1-2 and 6-7, sheath assembly (100) and dilator assembly (200); Paragraphs [0042] and [0043]), comprising:
a valve (Figure 1, hub (110) of sheath assembly (100); Paragraph [0042], discloses, “A hemostatic valve (not shown) may also be included within hub 110…”, thereby making the hub a valve) having a proximal end (Figure 1, end of hub (110) at cap (120)) and a distal end (Figure 1, end of hub (110) at butterfly/suture pad (140));
a catheter (Figure 1, sheath body (130) of sheath assembly (100); Paragraph [0042]) defining a lumen (Figures 8-9 and 10B-11, cavities (308) and (318); Paragraph [0058]) and coupled to the valve (Figure 1; Paragraph [0042]); and
a dilator (Figure 2, dilator assembly (200); Paragraph [0048]) configured to be positioned within the lumen through the valve (Figures 6-7 and 10B-11; Paragraphs [0056]-[0057] and [0064]-[0065]), wherein the dilator includes a notch (Figures 3A-3B, recess (245)) extending at least partially around a circumference of the dilator (Paragraph [0049]);
a first body region (Figure 2, dilator body (210); Paragraph [0048]) having a first flexibility profile (Paragraph [0051], discloses, “In some implementations, dilator body 210 may be other semi-rigid materials such as PEBA with other hardness ratings, polyethylene, polypropylene, or polyurethane.”); and
a second body region (Figure 2, dilator tip (220); Paragraph [0048]) having a second flexibility profile less than the first flexibility profile (Paragraph [0050], discloses, “In some implementations, dilator tip 220 may be formed of other flexible materials such as PEBA with other hardness ratings, silicone, thermoplastic polyurethane (“TPU”), or thermoplastic elastomer (“TPE”).” As such, a combination where the flexibility profile of tip (220) formed of PEBA (with a higher hardness rating) is indeed less flexible (stiffer/harder) than a dilator body (210) formed of polypropylene/ Polyethylene),
wherein the valve (hub (110)) is configured (ii) to sealingly engage against the dilator (dilator assembly (200)) when at least a portion of the dilator is inserted through the valve into the lumen (cavities (308) and (318)) of the catheter (sheath body (130)) (Paragraph [0042], discloses, “A hemostatic valve (not shown) may also be included within hub 110, the hemostatic valve being configured to prevent blood from leaking outside of the patient during insertion and/or removal of an intracardiac blood pump or other components.” This clearly indicates “sealing engagement” to achieve the stated purpose. Further, the disclosure of Figures 6-7 and Paragraphs [0056]-[0057] describing/showing the engagement between sheath assembly (100) and dilator assembly (200) reinforces such an engagement).
Korkuch does not explicitly teach, wherein the first body region and the second body region have a same diameter. Further, Korkuch fails to teach, wherein the valve is configured (i) to be releasably coupled to the dilator via the notch to inhibit movement of the dilator relative to the catheter.
Cope discloses, an introducer set including a sheath and dilator. Cope teaches, a dilator (Figure 5, dilator (30’)) comprising a first body region (Figures 5-6, portion of the dilator (30’) that the cannula/sheath (21’) is disposed coaxially about; Col. 5, line 34-36) and a second body region (Figure 6, portion of the dilator (30’) extending distally beyond the distal end (22’) of the sheath (21’); Col. 5, line 37-38), wherein the first body region and the second body region have a same diameter (Col. 5, line 67-Col. 6, line 6, discloses, “As noted above, with the exception of the annular ledge 36', which starts at the transition 50' and then tapers into the body of the dilator, the dilator has the same outer diameter inside the sheath as it does outside the sheath, from the proximal end of the dilator 30' to the beginning of the external taper at the distal end 31' of the dilator.” Meaning, that the main body of the dilator (30’)/ portion of the dilator (30’) that the cannula/sheath (21’) is disposed coaxially about and the portion of the dilator (30’) extending distally beyond the distal end (22’) of the sheath (21’), specifically, the portion between the ledge (36’) and distal end (31’), do indeed possess the same outer diameter as seen in Figure 6).
Merritt discloses, a hemostatic valve for sealing a wide range of medical devices, such as catheters, wires, embolectomy systems. Merritt teaches, a valve (Figure 1, valve (104); Paragraph [0035]; Where the valve (104) couples to the proximal/first end (108) of elongate sheath (106) of catheter (102) of delivery system (100)) configured to be releasably coupled to the dilator (Figure 4, tool (400); Where paragraph [0061] discloses that constricting mechanism (141) of valve (104) is capable of sealing the tool (400) and specifically the shaft (402) regardless of the size of tool (400) and that the valve can be used with a variety of tools. Thus, the tool is indeed capable of being a dilator) to inhibit movement of the dilator relative to the catheter (Figure 1, catheter (102)) (Paragraphs [0071]-[0076] discloses the method for sealing a valve and/or catheter. The method discloses advancing a tool (400) through the valve (104) with the constricting mechanism (141) in the open (second) configuration, then returning the constricting mechanism to the closed (first) configuration so that it tightens/collapses and seals the central lumen of the valve around the shaft (402) of the tool while the tool remains in position within the delivery device/catheter).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the dilator of Korkuch to incorporate the same outer diameter at its first (body) and second (tip) regions as taught by Cope (Examiner notes that Figure 10A (not to scale) of Korkuch already demonstrates that the body (210) and at a certain point of the taper of tip (220), the diameter is indeed the same, it is simply not explicitly taught in Korkuch’s disclosure, Cope is relied upon to reinforce that the limitation is known in the prior art), and to substitute or supplement the hemostatic valve engagement of Korkuch with the active tensioning filament/locking mechanism of Merritt for releasable coupling via the existing recess/notch of Korkuch as the dilator assembly is inserted through the sheath assembly, where engagement between the notch and valve becomes possible, as all the references and the claimed invention are directed to vascular access systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, first, Cope’s same outer diameter at both body regions of the dilator allows for avoiding major deformation of the catheter (Col. 6, line 60-67 of Cope) while preserving the differing flexibility profiles already present in Korkuch; and second, Merritt’s filament-based tensioning/locking mechanism provides reliable, user-controlled releasable locking and sealing around the dilator via Korkuch’s existing recess/notch ((245) engaging a step (316) of the sheath assembly (100); Paragraph [0049] and Figure 10B of Korkuch), directly addressing Korkuch’s goals of preventing over-insertion, back-sliding, and unwanted relative movement while enabling the hemostasis benefits already sought in Korkuch’s hub valve.
Regarding claim 12, Korkuch further teaches, wherein the first body region (dilator body (210)) comprises a first material (Paragraph [0051], discloses, “In some implementations, dilator body 210 may be other semi-rigid materials such as PEBA with other hardness ratings, polyethylene, polypropylene, or polyurethane.”), and wherein the second body region (dilator tip (220)) comprises a second material (Paragraph [0050], discloses, “In some implementations, dilator tip 220 may be formed of other flexible materials such as PEBA with other hardness ratings, silicone, thermoplastic polyurethane (“TPU”), or thermoplastic elastomer (“TPE”).”) different than the first material (The cited disclosures of Korkuch clearly demonstrate that the material of the dilator body (210) is indeed capable of being different from the material of dilator tip (220)).
Regarding claim 14, Korkuch further teaches, wherein the notch (recess (245)) defines a recessed region of the dilator having a notch diameter less than the diameter of the first body region (dilator body (210)) and the second body region (dilator tip (220)) (Paragraph [0049], discloses, “…the cylindrical section (247) is followed by a recess (245) with a smaller outer diameter…”; see Figure 10B).
Regarding claim 15, modified Korkuch teaches, wherein the valve includes a tether (Figures 2-3 of Merritt, filament (150) of constricting mechanism (14) of valve (104); Paragraph [0043] of Merritt), and wherein the tether is configured to be positioned at least partially within the notch (recess (245) of Korkuch) to releasably couple the dilator (dilator assembly (200) of Korkuch) to the valve (valve (104) of Merritt) (Paragraphs [0042]-[0044] and [0071]-[0076] of Merritt, disclosed that the filament (150) collapses and seals around the shaft (402) of the inserted tool (400) when in the closed configuration. Thus, and in view of the modification set forth in the rejection of claim 9, one of ordinary skill would have used Merritt’s tether/filament mechanism as the valve’s coupling and sealing structure that interacts with the notch already present on the dilator of Korkuch. This is a direct and predictable application of Merritt’s explicit teaching of the tether engaging an inserted device to achieve releasable coupling and inhibition of relative movement. No additional motivation beyond the combination already applied to the independent claim 9 is required, the claim merely recites the specific implementation details of that very valve mechanism taught by Merritt).
Regarding claim 16, modified Korkuch teaches, wherein the tether (filament (150) of Merritt) is biased in a first direction to releasably couple the dilator (dilator assembly (200) of Korkuch) to the valve (valve (104) of Merritt) (Figure 2 and Paragraphs [0045]-[0049] of Merritt describe springs (148-A & 148-B) bias the constricting mechanism (141) toward the closed/first configuration in which the filament constricts and seals), the valve further comprising a button (Figures 1-3 of Merritt, buttons (144); Paragraph [0043] of Merritt) operably coupled to the tether and configured to move the tether in a second direction, opposite the first direction, to cause the tether to uncouple the dilator from the valve (Figure 3 and Paragraph [0050] of Merritt describe depressing the buttons, moves the filament to the open/second configuration to release the constriction) (The base modification for claim 9 already replaces/supplements Korkuch’s hemostatic valve engagement with Merritt’s active tensioning valve (including the filament, bias springs, and buttons) to achieve secure, releasable coupling via the dilator’s notch while providing superior hemostasis and control. No additional motivation beyond the combination already applied to the independent claim 9 is required, the claim merely recites the specific implementation details of that very valve mechanism taught by Merritt).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korkuch, in view of Cope and Merritt, as applied to claim 9 above, and further in view of Yee (US 2001/0037141 A1).
Regarding claim 17, Korkuch teaches, the notch (recess (245)) of the dilator (dilator assembly (200)) is a first notch.
Korkuch fails to teach, wherein the dilator further includes a second notch positioned on a proximal side or a distal side of the first notch.
Cope teaches, aspects of the vascular access system according to claim 9 (See above rejection of claim 9).
Merritt teaches, other aspects of the vascular access system according to claim 9 (See above rejection of claim 9).
Yee discloses, a multi-sheath delivery catheter. Yee teaches, handles (20 & 21) (see Figures 3-5) that function as (and are expressly equated to) tubes/catheters: handle (20) is attached to (or formed as the distal end of) the innermost tube pusher (13), and handle (21) is attached to (or formed as the distal end of) the middle sheath/tube (12) (Paragraphs [0036]-[0038] and [0040]; Yee explicitly states that the handles may be formed integrally with or as the tubes themselves, or that the tubes may be formed entirely in the non-round profile such that the “handles” are effectively simply the distal ends of the tubes). These tube/handle structures include discrete engagement features (e.g., notches (49) formed in the corners of handle/tube (20) that receive prongs (41) of a prong assembly (40) for selective locking (see Figures 6-6A; Paragraph [0050]-[0053]); and multiple sets of notches (57) formed in handle/tube (20) that are selectively engaged by the cam surface of cam-lock knob (51) (see Figures 9-13; Paragraphs [0057]-[0062], with paragraph [0062] specifically disclosing, “…cam-lock assembly 50 has the ability to lock handle 20 in more than one position if multiple sets of notches 57 are provided. This may be useful when deploying different sizes of prostheses, for example. Notches 57 in handle 20 may be machined, by methods known to those skilled in the art, before the device is assembled. Notches 57 may also be molded instead of machined, or cut after assembly but before locking.”)). Thus, Yee is teaching that multiple sets of notches may be provided and how they may be formed along the tube/handle so that the locking/engagement position can be selected among different axial locations. The multiple notches are allowing selective axial positioning (and locking against further relative movement) of the inner tube relative to the outer tube(s), thereby adjusting the relative length of the inner component that extends beyond the outer component to accommodate different prosthesis sizes without requiring a different-length inner tube.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to further modify the dilator of Korkuch (as already modified by Cope to provide same-diameter body regions of differing flexibility and by Merritt to provide releasable valve-to-notch coupling the inhibits relative movement while sealing) by adding a second notch on the proximal side or distal side of the first notch (recess (245)), as taught by the multiple notches/notch sets of Yee on the inner tube (handle (20)/pusher (13)), as all the references and the claimed invention are directed to vascular access/introducer systems employing coaxial inner and outer components. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, providing a second discrete notch at a different axial location on the dilator would enable the valve (already configured per Merritt to releasably engage a notch via its tether/filament to inhibit relative movement) to lock the dilator at a second selectable axial position relative to the catheter (Paragraph [0062] of Yee). The modification uses known techniques (adding axially spaced recesses for selective engagement) for their known purpose (selectable axial locking of coaxial tubes) with no change in their respective functions, yielding only the expected benefit of greater positional control and versatility already sought in Korkuch’s interlock system (prevention of over-insertion, back-sliding, and unwanted relative movement). See MPEP 2143 (I)(A), (C), & (G); KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Regarding claim 18, Korkuch teaches, wherein the catheter (sheath body (130) of Korkuch) includes a distal terminus (Figures 1, 8-9, and 10B, tapered sheath tip (150); Paragraph [0042]). Korkuch further teaches, the dilator extends beyond the distal terminus (Figures 10B-11; Paragraph [0065])
Korkuch fails to teach, wherein a first length of the dilator extends beyond the distal terminus when the first notch is coupled to the valve, and wherein a second length of the dilator extends beyond the distal terminus when the second notch is coupled to the valve.
Cope teaches, aspects of the vascular access system according to claim 9 (See above rejection of claim 9).
Merritt teaches, the valve (valve (104)) of claim 9 (See above rejection of claim 9).
Yee teaches, the multiple axially spaced notches (notches (57)) on the inner tube are expressly for locking the inner component at different relative axial positions with respect to the outer tube(s) (to accommodate different prosthesis sizes) (Paragraph [0062]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would knowingly determine that applying the above teaching of Yee’s notches to Korkuch’s dilator necessarily produces different lengths of the dilator extending beyond the catheter’s distal terminus depending on which notch is coupled to the valve, where engagement at the more distal notch yields a shorter protruding length, while engagement at the more proximal notch yields a longer protruding length, as all the references and the claimed invention are directed to vascular access/introducer systems employing coaxial inner and outer components. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the notches this way for the same reasons given for claim 17, namely, to allow a single dilator to provide selectable extension lengths for different clinical needs without requiring multiple dilators of different lengths (using known elements for their known purpose with predictable results). See MPEP 2143; KSR v. Teleflex.
Regarding claim 19, modified Korkuch teaches, wherein the second length is greater than the first length (as stated in the above rejection of claim 18, applying the teaching of Yee’s notches to Korkuch’s dilator necessarily produces different lengths of the dilator extending beyond the catheter’s distal terminus depending on which notch is coupled to the valve, where engagement at the more distal notch yields a shorter protruding length, while engagement at the more proximal notch yields a longer protruding length; same reasons given for claim 17 and 18 above).
Claim(s) 25-28 and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korkuch, in view of Merritt.
Regarding claim 25, Korkuch teaches, a vascular access system (Figures 1-2 and 6-7, sheath assembly (100) and dilator assembly (200); Paragraphs [0042] and [0043]), comprising:
a dilator extending along a longitudinal axis (Figure 2, dilator assembly (200); Paragraph [0048]), wherein the dilator has a varying flexibility profile at least partially along the longitudinal axis (Paragraph [0050]-[0051], clearly demonstrate that the dilator assembly (200) has a varying flexibility profile across its dilator body (210) and dilator tip (220). It is explicitly disclosed that the body is made of a "semi-rigid" material and the tip is made of a "flexible" material), and wherein the dilator defines a notch (Figures 3A-3B, recess (245)) extending at least partially circumferentially about the longitudinal axis (Paragraph [0049]);
a valve (Figure 1, hub (110) of sheath assembly (100); Paragraph [0042], discloses, “A hemostatic valve (not shown) may also be included within hub 110…”) having a proximal end (Figure 1, end of hub (110) at cap (120)) and a distal end (Figure 1, end of hub (110) at butterfly/suture pad (140)); and
a catheter (Figure 1, sheath body (130) of sheath assembly (100); Paragraph [0042]) coupled to the valve (Figure 1; Paragraph [0042]) and defining a lumen (Figures 8-9 and 10B-11, cavities (308) and (318); Paragraph [0058]);
wherein the valve (hub (110)) is configured (ii) to sealingly engage against the dilator (dilator assembly (200)) when at least a portion of the dilator is inserted through the valve into the lumen (cavities (308) and (318)) of the catheter (sheath body (130)) (Paragraph [0042], discloses, “A hemostatic valve (not shown) may also be included within hub 110, the hemostatic valve being configured to prevent blood from leaking outside of the patient during insertion and/or removal of an intracardiac blood pump or other components.” This clearly indicates “sealing engagement” to achieve the stated purpose. Further, the disclosure of Figures 6-7 and Paragraphs [0056]-[0057] describing/showing the engagement between sheath assembly (100) and dilator assembly (200) reinforces such an engagement).
Korkuch fails to teach, wherein the valve is configured (i) to be releasably coupled to the dilator via the notch to inhibit movement of the dilator relative to the catheter.
Merritt teaches, a valve (Figure 1, valve (104); Paragraph [0035]; Where the valve (104) couples to the proximal/first end (108) of elongate sheath (106) of catheter (102) of delivery system (100)) configured to be releasably coupled to the dilator (Figure 4, tool (400); Where paragraph [0061] discloses that constricting mechanism (141) of valve (104) is capable of sealing the tool (400) and specifically the shaft (402) regardless of the size of tool (400) and that the valve can be used with a variety of tools. Thus, the tool is indeed capable of being a dilator) to inhibit movement of the dilator relative to the catheter (Figure 1, catheter (102)) (Paragraphs [0071]-[0076] discloses the method for sealing a valve and/or catheter. The method discloses advancing a tool (400) through the valve (104) with the constricting mechanism (141) in the open (second) configuration, then returning the constricting mechanism to the closed (first) configuration so that it tightens/collapses and seals the central lumen of the valve around the shaft (402) of the tool while the tool remains in position within the delivery device/catheter).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to substitute or supplement the hemostatic valve engagement of Korkuch with the active tensioning filament/locking mechanism of Merritt for releasable coupling via the existing recess/notch of Korkuch, as both references and the claimed invention are directed to vascular access systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, Merritt’s filament-based tensioning/locking mechanism provides reliable, user-controlled releasable locking and sealing around the dilator via Korkuch’s existing recess/notch ((245) engaging a step (316) of the sheath assembly (100); Paragraph [0049] and Figure 10B of Korkuch), directly addressing Korkuch’s goals of preventing over-insertion, back-sliding, and unwanted relative movement while enabling the hemostasis benefits already sought in Korkuch’s hub valve.
Regarding claim 26, Korkuch further teaches, wherein the dilator (dilator assembly (200)) includes a body region (Figure 2, dilator body (210); Paragraph [0048]) having a diameter (Figure 10B), and wherein the notch (recess (245)) includes a recessed region of the dilator having a notch diameter less than the diameter of the body region (Paragraph [0049], discloses, “…the cylindrical section (247) is followed by a recess (245) with a smaller outer diameter…”; see Figure 10B).
Regarding claim 27, modified Korkuch teaches, wherein the valve includes a tether (Figures 2-3 of Merritt, filament (150) of constricting mechanism (14) of valve (104); Paragraph [0043] of Merritt), and wherein the tether is configured to be positioned at least partially within the notch (recess (245) of Korkuch) to releasably couple the dilator (dilator assembly (200) of Korkuch) to the valve (valve (104) of Merritt) (Paragraphs [0042]-[0044] and [0071]-[0076] of Merritt, disclosed that the filament (150) collapses and seals around the shaft (402) of the inserted tool (400) when in the closed configuration. Thus, and in view of the modification set forth in the rejection of claim 9, one of ordinary skill would have used Merritt’s tether/filament mechanism as the valve’s coupling and sealing structure that interacts with the notch already present on the dilator of Korkuch. This is a direct and predictable application of Merritt’s explicit teaching of the tether engaging an inserted device to achieve releasable coupling and inhibition of relative movement. No additional motivation beyond the combination already applied to the independent claim 25 is required, the claim merely recites the specific implementation details of that very valve mechanism taught by Merritt).
Regarding claim 28, modified Korkuch teaches, wherein the tether (filament (150) of Merritt) is biased in a first direction to releasably couple the dilator (dilator assembly (200) of Korkuch) to the valve (valve (104) of Merritt) (Figure 2 and Paragraphs [0045]-[0049] of Merritt describe springs (148-A & 148-B) bias the constricting mechanism (141) toward the closed/first configuration in which the filament constricts and seals), the valve further comprising a button (Figures 1-3 of Merritt, buttons (144); Paragraph [0043] of Merritt) operably coupled to the tether and configured to move the tether in a second direction, opposite the first direction, to move the tether at least partially out of the notch to uncouple the dilator from the valve (Figure 3 and Paragraph [0050] of Merritt describe depressing the buttons, moves the filament to the open/second configuration to release the constriction) (The base modification for claim 25 already replaces/supplements Korkuch’s hemostatic valve engagement with Merritt’s active tensioning valve (including the filament, bias springs, and buttons) to achieve secure, releasable coupling via the dilator’s notch while providing superior hemostasis and control. No additional motivation beyond the combination already applied to the independent claim 28 is required, the claim merely recites the specific implementation details of that very valve mechanism taught by Merritt).
Regarding claim 32, Korkuch further teaches, wherein the dilator (dilator assembly (200)) includes a proximal body region (Figure 2, dilator body (210); Paragraph [0048]) having a first flexibility profile (Paragraph [0051], discloses, “…dilator body 210 may be formed of a semi-rigid material such as PEBA with a durometer hardness of 70D. In some implementations, dilator body 210 may be other semi-rigid materials such as PEBA with other hardness ratings, polyethylene, polypropylene, or polyurethane.”) and a distal body region (Figure 2, dilator tip (220); Paragraph [0048]) having a second flexibility profile greater than the first flexibility profile (Paragraph [0050], discloses, “…dilator tip 220 may be formed of a flexible material such as polyether block amide (“PEBA”) with a durometer hardness of 40D. In some implementations, dilator tip 220 may be formed of other flexible materials such as PEBA with other hardness ratings, silicone, thermoplastic polyurethane (“TPU”), or thermoplastic elastomer (“TPE”).” As such, the flexibility profile of tip (220) is indeed greater than the flexibility profile of body (210)), wherein the notch (recess (245)) is positioned at least partially between the proximal body region and the distal body region (As seen in Figures 2-3B, recess (245) is indeed between body (210) and tip (220)).
Regarding claim 33, Korkuch further teaches, wherein the dilator (dilator assembly (200)) has a varying durometer at least partially along the longitudinal axis (Paragraph [0050], discloses the durometer hardness of dilator tip (220) formed of a flexible material such as polyether block amide (“PEBA”) is 40D. Further, Paragraph [0051], discloses the durometer hardness of dilator body (210) formed of a semi-rigid material such as PEBA is 70D).
Claim(s) 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Korkuch, in view of Merritt as applied to claim 25 above, and further in view of Yee.
Regarding claim 29, Korkuch teaches, the notch (recess (245)) of the dilator (dilator assembly (200)) is a first notch. Korkuch further teaches, the portion of the dilator is a first portion (Figure 2, dilator tip (220); Paragraph [0048]), and a second portion of the dilator (Figure 2, dilator body (210); Paragraph [0048]) is inserted through the valve (hub (110)) into the lumen (cavities (308) and (318)) of the catheter (sheath body (130)) (Figures 6-7 and 10B-11; Paragraphs [0056]-[0057] and [0063]-[0065]).
Korkuch fails to teach, wherein the dilator further defines a second notch extending at least partially circumferentially about the longitudinal axis, and wherein the valve is configured to be releasably coupled to the dilator via the second notch to inhibit movement of the dilator relative to the catheter when at least the second portion of the dilator is inserted through the valve into the lumen of the catheter.
Merritt teaches, the valve (valve (104)) of claim 25 (See above rejection of claim 25).
Yee teaches, handles (20 & 21) (see Figures 3-5) that function as (and are expressly equated to) tubes/catheters: handle (20) is attached to (or formed as the distal end of) the innermost tube pusher (13), and handle (21) is attached to (or formed as the distal end of) the middle sheath/tube (12) (Paragraphs [0036]-[0038] and [0040]; Yee explicitly states that the handles may be formed integrally with or as the tubes themselves, or that the tubes may be formed entirely in the non-round profile such that the “handles” are effectively simply the distal ends of the tubes). These tube/handle structures include discrete engagement features (e.g., notches (49) formed in the corners of handle/tube (20) that receive prongs (41) of a prong assembly (40) for selective locking (see Figures 6-6A; Paragraph [0050]-[0053]); and multiple sets of notches (57) formed in handle/tube (20) that are selectively engaged by the cam surface of cam-lock knob (51) (see Figures 9-13; Paragraphs [0057]-[0062], with paragraph [0062] specifically disclosing, “…cam-lock assembly 50 has the ability to lock handle 20 in more than one position if multiple sets of notches 57 are provided. This may be useful when deploying different sizes of prostheses, for example. Notches 57 in handle 20 may be machined, by methods known to those skilled in the art, before the device is assembled. Notches 57 may also be molded instead of machined, or cut after assembly but before locking.”)). Thus, Yee is teaching that multiple sets of notches may be provided and how they may be formed along the tube/handle so that the locking/engagement position can be selected among different axial locations. The multiple notches are allowing selective axial positioning (and locking against further relative movement) of the inner tube relative to the outer tube(s), thereby adjusting the relative length of the inner component that extends beyond the outer component to accommodate different prosthesis sizes without requiring a different-length inner tube.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to further modify the dilator of Korkuch (as already modified by Cope to provide same-diameter body regions of differing flexibility and by Merritt to provide releasable valve-to-notch coupling the inhibits relative movement while sealing) by adding a second notch on the proximal side or distal side of the first notch (recess (245)), as taught by the multiple notches/notch sets of Yee on the inner tube (handle (20)/pusher (13)), as all the references and the claimed invention are directed to vascular access/introducer systems employing coaxial inner and outer components. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this modification, as such a modification would have been predictable, namely, providing a second discrete notch at a different axial location on the dilator would enable the valve (already configured per Merritt to releasably engage a notch via its tether/filament to inhibit relative movement) to lock the dilator at a second selectable axial position relative to the catheter (Paragraph [0062] of Yee), when different axial portions of the dilator are inserted through the valve into the catheter lumen. The modification uses known techniques (adding axially spaced recesses for selective engagement) for their known purpose (selectable axial locking of coaxial tubes) with no change in their respective functions, yielding only the expected benefit of greater positional control and versatility already sought in Korkuch’s interlock system (prevention of over-insertion, back-sliding, and unwanted relative movement). See MPEP 2143 (I)(A), (C), & (G); KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Regarding claim 30, Korkuch teaches, wherein the catheter (sheath body (130) of Korkuch) includes a distal terminus (Figures 1, 8-9, and 10B, tapered sheath tip (150); Paragraph [0042]). Korkuch further teaches, the dilator extends beyond the distal terminus (Figures 10B-11; Paragraph [0065])
Korkuch fails to teach, wherein a first length of the dilator extends beyond the distal terminus when the first notch is coupled to the valve, and wherein a second length of the dilator extends beyond the distal terminus when the second notch is coupled to the valve.
Merritt teaches, the valve (valve (104)) of claim 25 (See above rejection of claim 25).
Yee teaches, the multiple axially spaced notches (notches (57)) on the inner tube are expressly for locking the inner component at different relative axial positions with respect to the outer tube(s) (to accommodate different prosthesis sizes) (Paragraph [0062]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would knowingly determine that applying the above teaching of Yee’s notches to Korkuch’s dilator necessarily produces different lengths of the dilator extending beyond the catheter’s distal terminus depending on which notch is coupled to the valve, where engagement at the more distal notch yields a shorter protruding length, while engagement at the more proximal notch yields a longer protruding length, as all the references and the claimed invention are directed to vascular access/introducer systems employing coaxial inner and outer components. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the notches this way for the same reasons given for claim 29, namely, to allow a single dilator to provide selectable extension lengths for different clinical needs without requiring multiple dilators of different lengths (using known elements for their known purpose with predictable results). See MPEP 2143; KSR v. Teleflex.
Regarding claim 31, modified Korkuch teaches, wherein the second length is greater than the first length (as stated in the above rejection of claim 30, applying the teaching of Yee’s notches to Korkuch’s dilator necessarily produces different lengths of the dilator extending beyond the catheter’s distal terminus depending on which notch is coupled to the valve, where engagement at the more distal notch yields a shorter protruding length, while engagement at the more proximal notch yields a longer protruding length; same reasons given for claim 29 and 30 above).
Response to Arguments
Applicant’s arguments with respect to claim(s) 9 and 25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
See updated rejections above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 6,336,914 B1 is relevant because it teaches a releasable interlock (grooves and protrusions) between a dilator hub and introducer/sheath hub that axially locks the dilator against relative movement during insertion while permitting intentional disengagement.
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 OSAMA NEMER whose telephone number is (571)272-6365. The examiner can normally be reached Monday-Friday 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
