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 .
Election/Restrictions
Applicant’s election without traverse of claims 9-19 and 25-33 in the reply filed on 10/21/2025 is acknowledged. Further, claims 1-8 and 20-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 08/01/2023, 05/03/2024, 12/18/2024, and 10/21/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc.
The abstract of the disclosure is objected to because:
The abstract begins with the phrase “Disclosed herein” which is an implied phrase. The abstract should avoid using phrases which can be implied.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The section “BRIEF SUMMARY OF THE INVENTION” is missing. Examiner notes that paragraphs [0013]-[0015] appear to be suitable for the “BRIEF SUMMARY OF THE INVENTION” section which as noted above is situated between the “Background” section and the “Brief Description of Drawings” section in the specification.
Paragraph [0036] should be amended to the following, “Generally, a difference in size between the third diameter Dc and a diameter of a body region positioned proximal and adjacent to the notch 250 (e.g., the first diameter Da of the first body region 244 a) can be associated with a resistive force/interference fit that inhibits or prevents further distal movement of the dilator 240 through the system 100 (e.g., through the catheter 120) and/or further proximal movement of the system 100 over the dilator 240. Additionally, a difference in size between the third diameter Dc and a diameter of a body region positioned distal and adjacent to the notch 250 (e.g., the second diameter Db of the second body region 244 b) can be associated with a resistive force/interference fit that at least inhibits or prevents further proximal movement of the dilator 240 through the system 100 and/or further distal movement of the system 100 over the dilator 240. For example, if the difference between third diameter Dc and the first diameter Da is between about 0.1 mm and about 0.5 mm, the resistive force/interference fit can be relatively slight and partially prevent further (distal) movement of the dilator 240 and/or further (proximal) movement of the system 100. In such embodiments, the resistive force/interference fit may provide a tactile indication or sensation (e.g., a “clicking” sound or sensation perceptible to a user) associated with the relative positions of the dilator 240 and the system 100, and any resistance/interference to further movement may be overcome by applying increased force to the dilator 240 and/or the system 100 to decouple the notch 250 and the valve 130 (e.g., the tether 336). As another example, if the difference between the third diameter Dc and the first diameter Da is greater than 0.5 mm, the resistive force/interference fit can be relatively substantial and fully prevent further (distal) movement of the dilator 240 and/or further (proximal) movement of the system 100. In such embodiments, the resistive force/interference fit may be overcome by actuating one or more of the buttons 338 of the valve 130 to release the dilator 240. Dilators with greater diameters can include notches having a greater depth (e.g., corresponding to a greater difference between the third diameter Dc and the first and/or second diameters Da, Db) than dilators with a comparatively lesser depth, and greater notch depths are expected to provide increased resistive forces/interference fits than lesser notch depths.”
Paragraph [0042] should be amended to the following, “Referring to FIG. 4B, the dilator 240 can be advanced from the first state 401 a to the second state 401 b by advancing the dilator 240 distally through the system 100 and/or retracting the system 100 proximally over the dilator 240. In the second state 401 b, a second length L2 of the dilator 240 can extend distally beyond the distal terminus 126 b. The second length L2 can be greater than the first length L1. In at least some embodiments, for example, the second length L2 is between about 5 cm and about 20 cm, such as at least 15 cm, or another suitable length therebetween. In the second state 401 b, the dilator 240 and the catheter 120 can be in a “rail” or “telescoping delivery” mode or configuration in which the catheter 120 can be advanced into and/or through the patient's vasculature while sliding along and/or otherwise moving over (e.g., telescopically over) the dilator 240. In at least some embodiments, telescopically inserting the catheter 120 over the dilator 240 can include moving from the second state 401 b to and/or toward the first state 401 a (FIG. 4A). In these and other embodiments, once the dilator 240 and/or the catheter 120 are positioned at or near a target location, the dilator 240 may then be removed from the catheter 120 the so that the system 100 can be used to treat and/or remove clot material from within the patient.”
Appropriate correction is required.
Claim Objections
Claims 10-12, 14-19, and 26-33 are objected to because of the following informalities:
Each of claims 10-12, 14-19, and 26-33 is missing a comma after the phrase, “The vascular access system of claim #” it should be “The vascular access system of claim #,”.
Claim 17 should be amended to following to avoid ambiguity, “The vascular access system of claim 13 wherein the notch is a first notch, and wherein the dilator further includes a second notch positioned on a proximal side or a distal side of the first notch.”
Appropriate correction is required.
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) 9-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lepulu (US Patent No. 6533770 B1).
Regarding claim 9, Lepulu discloses, a vascular access system (Figures 1-4; Col. 4, line 60-62), comprising:
a valve having a proximal end and a distal end (Figures 1-4, connector plug (71) with wiper-type hemostasis seal (72); Col. 6, line 9-16, “a connector plug 71, which is molded of a soft, elastomeric material, is placed over the barbed connector 59. A tapered dilator 67 is passed through a wiper-type hemostasis seal 72 in the connector plug 71. The wiper-type hemostasis seal 72 is a hole through the elastomeric connector plug 71 that has a slight interference fit with the external diameter of the dilator 67.” Under the broadest reasonable interpretation (BRI), seal (72) in plug (71) is a valve providing hemostasis/sealing, with proximal end at hub (70) side and distal end at insertion into lumen (57));
a catheter (Figures 1 and 3-4, cannula (50)) defining a lumen (Figures 1 and 3-4, lumen (57)) (Col. 4, line 63-Col. 5, line 62) and coupled to the valve (Col. 5, line 20-26, “The cannula 50 has a body 51 … a blood flow lumen 57 extending between the proximal end 52 and the distal end 53 …” coupled to plug (71)/seal (72) as shown in Figure 1, where dilator (67) passes through seal (72) into lumen (57)); and
a dilator (Figure 1, dilator (67)) configured to be positioned within the lumen through the valve (Col. 6, line 11-26, “A tapered dilator 67 is passed through a wiper-type hemostasis seal 72 in the connector plug 71 … The diameter of the dilator 67 is such that the dilator 67 substantially fills the cannula lumen 57 at the distal end 53 of the cannula body 51.” Dilator (67) is positioned within lumen (57) through valve (seal (72)/plug (71))), wherein the dilator includes a first body region having a first flexibility profile (Figure 1, main shaft of dilator (67) including proximal hub (70); Col. 6, line 39-41, “… the tapered dilator 67 is made of extruded polyurethane with a radiopaque filler …” extruded main shaft is stiffer for pushability (first profile)); and
a second body region having a second flexibility profile (Figure 1, near tapered distal tip (69); Col. 6, line 21; tapered distal tip (69) is thinner, softer, more flexible) less than the first flexibility profile (the second profile has less stiffness/mor flexibility than main shaft, as thinner tapered polyurethane is inherently less stiff),
wherein the first body region and the second body region have a same diameter (Col. 6, line 24-26, “The diameter of the dilator 67 is such that the dilator 67 substantially fills the cannula lumen 57 at the distal end 53 of the cannula body 51.” The main shaft and base of taper (proximal end/region) have the same uniform diameter filling lumen (57); before full taper starts, regions share the same diameter).
Examiner further notes, the tapered distal tip (69) of the dilator (67) necessarily possesses a lower flexibility profile (i.e., greater flexibility, lower stiffness) than the main extruded shaft body, because the taper reduces cross-sectional area and material mass, inherently resulting in reduced bending resistance and increased flexibility compared to the uniform, non-tapered proximal shaft region (MPEP 2112.01 – inherent properties necessarily present). The use of extruded polyurethane in the main shaft provides structural rigidity suitable for pushability, while the tapered tip is designed to be atraumatic and trackable, which requires greater flexibility (lower stiffness profile). Thus, the dilator inherently includes a first body region (main shaft) having a first flexibility profile and a second body region (tapered tip region) having a second flexibility profile less than the first.
Regarding claim 10, Lepulu further discloses, wherein the first body region has a first stiffness, wherein the second body region has a second stiffness, and wherein the first stiffness is greater than the second stiffness (dilator (67) main shaft extruded stiffer while distal tip (69) is tapered/thinner, less stiff).
Regarding claim 11, Lepulu further discloses, wherein the first body region has a first durometer, wherein the second body region has a second durometer, and wherein the second durometer is less than the first durometer (Inherent from “extruded polyurethane” where main shaft has a higher durometer for stiffness while tapered tip has low durometer for softness/atraumatic).
Regarding claim 12, Lepulu further discloses, wherein the first body region comprises a first material, and wherein the second body region comprises a second material different than the first material (Col. 21-42, main shaft is made of “extruded polyurethane” and while the tip is an extension of it, it will include “radiopaque filler so that the position of the dilator can be verified fluoroscopically” and it specifically will have the “radiopaque filler” because it is the part of dilator (67) that emerges from the end (53) of body (51) of cannula (50). Otherwise, main shaft variant which can include markers (74 & 75) which are made of nontoxic, biocompatible ink is considered to have a material different than a tapered distal tip (69) that is merely “extruded polyurethane”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13-19 and 25-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lepulu, in view of Graham (US PGPUB No. 20110077621 A1).
Regarding claim 13, Lepulu teaches, the dilator (dilator (67)) and the valve (plug (71)/seal (72)).
Lepulu fails to teach, wherein the dilator further includes a notch configured to extend at least partially around a longitudinal axis of the dilator, wherein the valve is configured to be releasably coupled to the dilator via the notch.
Graham discloses, a locking mechanism for selectively locking a first elongate member from longitudinal movement relative to a second elongate member of the medical device. Graham teaches, a vascular access locking system (Figures 1-2, drainage catheter delivery system (10); Paragraph [0030]) where a dilator (Figure 2, elongate member (40); Paragraph [0034]) includes a notch configured to extend at least partially around a longitudinal axis of the dilator (Paragraph [0045], “Similarly, the elongate member 40 and/or the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.” This is explicitly teaching notching/grooving the elongate member (40) for better grip/engagement; grooves/notches are indeed circumferential or extend around the axis improving interaction with the locking member), wherein the valve (Figures 1-6, handle assembly (16); Paragraphs [0035]-[0044]) is configured to be releasably coupled to the dilator via the notch (Figures 5-6 along with paragraph [0045] disclose flexible tubular member (54) of locking mechanism (50) of handle assembly (16) as compressing against elongate member (40); where flexible tubular member (54) includes roughening, teeth, bumps, or grooves on surfaces (inner/outer) to enhance engagement, where engagement with grooves/notches will provide releasable coupling or grip).
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 Lepulu with the notching/grooving of Graham, in order to provide a releasable locking engagement with the valve, as both reference 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 modify the dilator of Lepulu with the notching/grooving of Graham, in order to provide a releasable locking engagement with the valve, as such modifications would have been predictable, namely, to provide a positively biased, releasable locking engagement that enhances grip, prevents inadvertent relative movement of the dilator during advancement, and allows easy unlocking for withdrawal or repositioning (Paragraph [0047] of Graham).
Regarding claim 14, modified Lepulu teaches, wherein the notch defines a recessed region of the dilator having a notch diameter less than the diameter of the first body region and the second body region (Paragraph [0045] of Graham, “the elongate member 40 and/or the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.” Grooves are recessed with reduced diameter in what are essentially notched areas).
Regarding claim 15, Lepulu teaches, the dilator (dilator (67)) and the valve (plug (71)/seal (72)).
Lepulu fails to teach, wherein the valve includes a tether, and wherein the tether is configured to be positioned at least partially within the notch to releasably couple the dilator to the valve.
Graham teaches, the valve (handle assembly (16)) includes a tether (Figures 4-6, flexible tubular member (54); Paragraph [0038]-[0039]), and wherein the tether is configured to be positioned at least partially within the notch to releasably couple the dilator (elongate member (40)) to the valve (Paragraph [0045] describes flexible tubular member (54) as being positioned to engage grooves/notches on elongate member (40) (tether-like compression), specifically, “… the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.”).
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 Lepulu with the notching/grooving and the valve with the tether-like compression of Graham, in order to provide a releasable locking engagement with the valve, as both reference 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 modify the dilator of Lepulu with the notching/grooving and the valve with the tether-like compression of Graham, in order to provide a releasable locking engagement with the valve, as such modifications would have been predictable, namely, to provide a positively biased, releasable locking engagement that enhances grip, prevents inadvertent relative movement of the dilator during advancement, and allows easy unlocking for withdrawal or repositioning (Paragraph [0047] of Graham with Figures 5-6 showing the mechanism achieving controlled locking/unlocking).
Regarding claim 16, Lepulu teaches, the dilator (dilator (67)) and the valve (plug (71)/seal (72)).
Lepulu fails to teach, wherein the tether is biased in a first direction to releasably couple the dilator to the valve, the valve further comprising a button 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.
Graham teaches, the tether (flexible tubular member (54)) is biased in a first direction to releasably couple the dilator (elongate member (40)) to the valve (handle assembly (16)), the valve further comprising a button (Figures 1 and 3-6, actuator (52); Paragraph [0036]-[0037]) 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 (Paragraphs [0041]-[0045]; actuator (52) as a button/lever pivots to release compression on flexible member (54); Where biased/compressed in locked state, moved oppositely to unlock/release).
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 Lepulu with the notching/grooving and the valve with the tether-like compression and button actuator of Graham, to provide a positively biased, releasable locking engagement that enhances grip, prevents inadvertent relative movement of the dilator during advancement, and allows easy unlocking for withdrawal or repositioning, as both reference 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 modify the dilator of Lepulu with the notching/grooving and the valve with the tether-like compression and button actuator of Graham, in order to provide a releasable locking engagement with the valve, as such modifications would have been predictable, namely, to provide a positively biased, releasable locking engagement that enhances grip, prevents inadvertent relative movement of the dilator during advancement, and allows easy unlocking for withdrawal or repositioning (Paragraph [0047] of Graham with Figures 5-6 showing the mechanism achieving controlled locking/unlocking).
Regarding claim 17, modified Lepulu teaches, wherein the notch is a first notch, and wherein the dilator further includes a second notch positioned on a proximal side or a distal side of the first notch (Paragraph [0045] of Graham, “the elongate member 40 and/or the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.” Where “grooves” is plural indicating multiple notches).
Regarding claim 18, Lepulu teaches, wherein the catheter (cannula (50)) includes a distal terminus (Figures 1 and 4, distal end (53); Col. 5, line 20-26), and the dilator (dilator (67)) extends to variable lengths beyond the distal terminus (Col. 6, line 27-42; The dilator extends to variable lengths beyond the terminus depending on how far the operator inserts it, where a preferred extension range of approximately 2 to 5 cm (more preferably 4 to 5 cm) when the dilator hub (70) is against the connector plug (71), but also the disclosed use of depth markers (74 & 75) on the dilator shaft to allow the operator to monitor and control insertion depth such that “… when the marker 74 is just proximal to the hemostasis seal 72 on the elastomeric connector plug 71, the tapered distal tip 69 of the dilator 67 is just emerging from the beveled end 53 of the body 51.” This does indeed show that different insertion depths and thus different extension lengths beyond distal end (53) of cannula (50) are possible, intended, and controlled by the operator).
Lepulu fails to teach, that the different extension lengths are the result of coupling the valve to a first notch versus a second notch on the dilator.
Graham teaches, the dilator (elongate member (40)) includes multiple engagement features/notches (Paragraph [0045]) that allow the valve (handle assembly (16) using flexible member (54)) to engage at different longitudinal positions along the dilator (elongate member (40)) (Where engaging a first groove/notch would result in the elongate member extending a first length beyond the distal end of the surrounding catheter/sheath, while engaging a second groove/notch (located proximally or distally of the first groove/notch) results in a second, different extension length (Figures 5-6 show variable locking positions that necessarily produce different protrusion/extension lengths of elongate member (40) relative to the distal end of the surrounding structure).
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 Lepulu by adding multiple notches/grooves along its length as taught by Graham, and to configure the valve/seal/plug of Lepulu to engage those notches in the manner taught by Graham, such that coupling the valve to the first notch results in a first extension length of the dilator beyond the distal terminus of the catheter (end (53) of Lepulu), and coupling to the second notch results in a second extension length, as both reference 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 modify the dilator of Lepulu by adding multiple notches/grooves along its length as taught by Graham, and to configure the valve/seal/plug of Lepulu to engage those notches in the manner taught by Graham, such that coupling the valve to the first notch results in a first extension length of the dilator beyond the distal terminus of the catheter (end (53) of Lepulu), and coupling to the second notch results in a second extension length, as such modifications would have been predictable, namely, allow the operator to select between different predefined depths using positive mechanical coupling, thereby improving precision, repeatability, and safety during vascular access by reducing the risk of over-or-under insertion (Figures 5-6 and Paragraphs [0047]-[0048] of Graham). The combination yields predictable results: Lepulu already contemplates variable dilator extension lengths beyond the distal terminus, and Graham’s multiple groove/notch features simply provide a mechanical way to achieve and lock those different lengths with positive engagement, enhancing control without introducing unexpected difficulties.
Regarding claim 19, modified Lepulu teaches, wherein the second length is greater than the first length (Paragraph [0045] of Graham, “the elongate member 40 and/or the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.” Where “grooves” is plural indicating multiple notches. As such, different locking points produce different extension lengths, allowing for the second length to be greater than the first length).
Regarding claim 25, Lepulu teaches, a vascular access system (Figures 1-4; Col. 4, line 60-62), comprising:
a dilator (Figure 1, dilator (67)) extending along a longitudinal axis (Figure 1; Col. 6, line 11-13 and line 21-42), wherein the dilator has a varying flexibility profile at least partially along the longitudinal axis (Figure 1, main shaft of dilator (67) including proximal hub (70) and near tapered distal tip (69); Col. 6, line 39-41, “… the tapered dilator 67 is made of extruded polyurethane with a radiopaque filler …” extruded main shaft is stiffer for pushability (first profile). Col. 6, line 21, tapered distal tip (69) is thinner, softer, more flexible. The tapered distal tip (69) of the dilator (67) necessarily possesses a lower flexibility profile (i.e., greater flexibility, lower stiffness) than the main extruded shaft body, because the taper reduces cross-sectional area and material mass, inherently resulting in reduced bending resistance and increased flexibility compared to the uniform, non-tapered proximal shaft region (MPEP 2112.01 – inherent properties necessarily present). The use of extruded polyurethane in the main shaft provides structural rigidity suitable for pushability, while the tapered tip is designed to be atraumatic and trackable, which requires greater flexibility (lower stiffness profile). Thus, the dilator inherently includes varying flexibility profile at least partially along the longitudinal axis);
a valve having a proximal end and a distal end (Figures 1-4, connector plug (71) with wiper-type hemostasis seal (72); Col. 6, line 9-16, “a connector plug 71, which is molded of a soft, elastomeric material, is placed over the barbed connector 59. A tapered dilator 67 is passed through a wiper-type hemostasis seal 72 in the connector plug 71. The wiper-type hemostasis seal 72 is a hole through the elastomeric connector plug 71 that has a slight interference fit with the external diameter of the dilator 67.” Under the broadest reasonable interpretation (BRI), seal (72) in plug (71) is a valve providing hemostasis/sealing, with proximal end at hub (70) side and distal end at insertion into lumen (57)); and
a catheter (Figures 1 and 3-4, cannula (50); Col. 4, line 63-Col. 5, line 62) coupled to the valve (Col. 5, line 20-26, “The cannula 50 has a body 51 … a blood flow lumen 57 extending between the proximal end 52 and the distal end 53 …” coupled to plug (71)/seal (72) as shown in Figure 1, where dilator (67) passes through seal (72) into lumen (57)) and defining a lumen (Figures 1 and 3-4, lumen (57)).
Lepulu fails to teach, wherein the dilator defines a 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 notch to inhibit movement of the dilator relative to the catheter when at least a portion of the dilator is inserted through the valve into the lumen of the catheter.
Graham teaches, a vascular access locking system (Figures 1-2, drainage catheter delivery system (10); Paragraph [0030]) where a dilator (Figure 2, elongate member (40); Paragraph [0034]) includes a notch extending at least partially circumferentially about the longitudinal axis of the dilator (Paragraph [0045], “Similarly, the elongate member 40 and/or the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.” This is explicitly teaching notching/grooving the elongate member (40) for better grip/engagement; grooves/notches are indeed circumferential or extend around the axis improving interaction with the locking member); and wherein the valve (Figures 1-6, handle assembly (16); Paragraphs [0035]-[0044]) is configured to be releasably coupled to the dilator via the notch to inhibit movement of the dilator relative to the catheter when at least a portion of the dilator is inserted through the valve into the lumen of the catheter (Figures 5-6 along with paragraph [0045] disclose flexible tubular member (54) of locking mechanism (50) of handle assembly (16) as compressing against elongate member (40); where flexible tubular member (54) includes roughening, teeth, bumps, or grooves on surfaces (inner/outer) to enhance engagement, where engagement with grooves/notches will inhibit movement of the dilator/elongate member (40) relative to the catheter/sheath/surrounding structure when at least a portion of the dilator/elongate member (40) is inserted through the valve (flexible tubular member (54)/handle assembly (16)) into the lumen of the catheter/sheath/surrounding structure).
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 Lepulu with the notching/grooving of Graham, in order to provide a releasable locking engagement with the valve (allowing for inhibiting movement of the dilator relative to the catheter when at least a portion of the dilator is inserted through the valve into the lumen of the catheter), as both reference 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 modify the dilator of Lepulu with the notching/grooving of Graham, in order to provide a releasable locking engagement with the valve (allowing for inhibiting movement of the dilator relative to the catheter when at least a portion of the dilator is inserted through the valve into the lumen of the catheter), as such modifications would have been predictable, namely, to provide a positively biased, releasable locking engagement that enhances grip, prevents inadvertent relative movement of the dilator during advancement, and allows easy unlocking for withdrawal or repositioning (Paragraph [0047] of Graham).
Regarding claim 26, modified Lepulu teaches, wherein the dilator includes a body region having a diameter (Col. 6, line 24-26 of Lepulu, “The diameter of the dilator 67 is such that the dilator 67 substantially fills the cannula lumen 57 at the distal end 53 of the cannula body 51.”), and wherein the notch includes a recessed region of the dilator having a notch diameter less than the diameter of the body region (Paragraph [0045] of Graham, “the elongate member 40 and/or the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.” Grooves are recessed with reduced diameter in what are essentially notched areas).
Regarding claim 27, Lepulu teaches, the dilator (dilator (67)) and the valve (plug (71)/seal (72)).
Lepulu fails to teach, wherein the valve includes a tether, and wherein the tether is configured to be positioned at least partially within the notch to releasably couple the dilator to the valve.
Graham teaches, the valve (handle assembly (16)) includes a tether (Figures 4-6, flexible tubular member (54); Paragraph [0038]-[0039]), and wherein the tether is configured to be positioned at least partially within the notch to releasably couple the dilator (elongate member (40)) to the valve (Paragraph [0045] describes flexible tubular member (54) as being positioned to engage grooves/notches on elongate member (40) (tether-like compression), specifically, “… the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.”).
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 Lepulu with the notching/grooving and the valve with the tether-like compression of Graham, in order to provide a releasable locking engagement with the valve, as both reference 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 modify the dilator of Lepulu with the notching/grooving and the valve with the tether-like compression of Graham, in order to provide a releasable locking engagement with the valve, as such modifications would have been predictable, namely, to provide a positively biased, releasable locking engagement that enhances grip, prevents inadvertent relative movement of the dilator during advancement, and allows easy unlocking for withdrawal or repositioning (Paragraph [0047] of Graham with Figures 5-6 showing the mechanism achieving controlled locking/unlocking).
Regarding claim 28, Lepulu teaches, the dilator (dilator (67)) and the valve (plug (71)/seal (72)).
Lepulu fails to teach, wherein the tether is biased in a first direction to releasably couple the dilator to the valve, the valve further comprising a button 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.
Graham teaches, the tether (flexible tubular member (54)) is biased in a first direction to releasably couple the dilator (elongate member (40)) to the valve (handle assembly (16)), the valve further comprising a button (Figures 1 and 3-6, actuator (52); Paragraph [0036]-[0037]) 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 (Paragraphs [0041]-[0045]; actuator (52) as a button/lever pivots to release compression on flexible member (54); Where biased/compressed in locked state, moved oppositely to unlock/release).
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 Lepulu with the notching/grooving and the valve with the tether-like compression and button actuator of Graham, to provide a positively biased, releasable locking engagement that enhances grip, prevents inadvertent relative movement of the dilator during advancement, and allows easy unlocking for withdrawal or repositioning, as both reference 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 modify the dilator of Lepulu with the notching/grooving and the valve with the tether-like compression and button actuator of Graham, in order to provide a releasable locking engagement with the valve, as such modifications would have been predictable, namely, to provide a positively biased, releasable locking engagement that enhances grip, prevents inadvertent relative movement of the dilator during advancement, and allows easy unlocking for withdrawal or repositioning (Paragraph [0047] of Graham with Figures 5-6 showing the mechanism achieving controlled locking/unlocking).
Regarding claim 29, Lepulu teaches, the dilator (dilator (67) extending along the longitudinal axis, having a varying flexibility profile (main shaft stiffer for pushability; tapered distal tip (69) softer/more flexible), configured for insertion through the valve (seal (72)/plug (71)) into the catheter lumen (lumen (57) of cannula (50)), wherein the valve is configured to releasably couple to the dilator to inhibit movement (Col. 6, line 11-18, wiper-type hemostasis seal (72) in connector plug (71) provides frictional engagement and sealing when dilator (67) is positioned therethrough).
Lepulu fails to teach, the dilator defining a first notch and a second notch extending at least partially circumferentially about the longitudinal axis; and wherein the valve is configured to releasably couple to the dilator via the second notch to inhibit movement when a second portion of the dilator is inserted.
Graham teaches, the dilator (elongate member (40)) includes multiple engagement features which would provide selective positional locking (Paragraph [0045], “the elongate member 40 and/or the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.” The use of plural “grooves” indicates the elongate member (40) is capable of defining a first notch/groove and a second notch/groove extending at least partially circumferentially about the longitudinal axis. The locking mechanism which includes flexible member (54) (effectively providing tether-like compression) is configured to releasably couple to member (40) via each groove/notch to inhibit relative movement when different portions of the member (40) are inserted. Figures 5-6 show flexible member (54) engaging the elongate member (40) at a given position; plural grooves allow engagement at different longitudinal locations, corresponding to different inserted portions being locked).
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 Lepulu by providing multiple notches/grooves along its length as taught by Graham, and to configure the valve of Lepulu to engage those notched in the manner taught by Graham, such that the valve is releasably coupled to the dilator via the first notch to inhibit movement when a first portion of the dilator is inserted through the valve into the lumen, and the valve is releasably coupled to the dilator via the second notch to inhibit movement when a second portion of the dilator is inserted, as both reference 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 modify the dilator of Lepulu by providing multiple notches/grooves along its length as taught by Graham, and to configure the valve of Lepulu to engage those notched in the manner taught by Graham, such that the valve is releasably coupled to the dilator via the first notch to inhibit movement when a first portion of the dilator is inserted through the valve into the lumen, and the valve is releasably coupled to the dilator via the second notch to inhibit movement when a second portion of the dilator is inserted, as such modifications would have been predictable, namely, provides multiple selectable locking positions that allow an operator to positively secure the dilator at different insertion depths, thereby improving precisions, repeatability, and safety during vascular access by preventing unintended axial movement at different stages of insertion (Figures 5-6 and Paragraphs [0047]-[0048] of Graham). The combination yields predictable results: Lepulu’s dilator is already inserted through a seal/valve into the catheter lumen and held by frictional engagement; Graham’s multiple groove/notch features simply provide additional, discrete mechanical coupling points that enhance that positional control without introducing unexpected interactions or technical difficulties.
Regarding claim 30, Lepulu teaches, wherein the catheter (cannula (50)) includes a distal terminus (Figures 1 and 4, distal end (53); Col. 5, line 20-26), and the dilator (dilator (67)) extends to variable lengths beyond the distal terminus (Col. 6, line 27-42; The dilator extends to variable lengths beyond the terminus depending on how far the operator inserts it, where a preferred extension range of approximately 2 to 5 cm (more preferably 4 to 5 cm) when the dilator hub (70) is against the connector plug (71), but also the disclosed use of depth markers (74 & 75) on the dilator shaft to allow the operator to monitor and control insertion depth such that “… when the marker 74 is just proximal to the hemostasis seal 72 on the elastomeric connector plug 71, the tapered distal tip 69 of the dilator 67 is just emerging from the beveled end 53 of the body 51.” This does indeed show that different insertion depths and thus different extension lengths beyond distal end (53) of cannula (50) are possible, intended, and controlled by the operator).
Lepulu fails to teach, that the different extension lengths are the result of coupling the valve to a first notch versus a second notch on the dilator.
Graham teaches, the dilator (elongate member (40)) includes multiple engagement features/notches (Paragraph [0045]) that allow the valve (handle assembly (16) using flexible member (54)) to engage at different longitudinal positions along the dilator (elongate member (40)) (Where engaging a first groove/notch would result in the elongate member extending a first length beyond the distal end of the surrounding catheter/sheath, while engaging a second groove/notch (located proximally or distally of the first groove/notch) results in a second, different extension length (Figures 5-6 show variable locking positions that necessarily produce different protrusion/extension lengths of elongate member (40) relative to the distal end of the surrounding structure).
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 Lepulu by adding multiple notches/grooves along its length as taught by Graham, and to configure the valve/seal/plug of Lepulu to engage those notches in the manner taught by Graham, such that coupling the valve to the first notch results in a first extension length of the dilator beyond the distal terminus of the catheter (end (53) of Lepulu), and coupling to the second notch results in a second extension length, as both reference 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 modify the dilator of Lepulu by adding multiple notches/grooves along its length as taught by Graham, and to configure the valve/seal/plug of Lepulu to engage those notches in the manner taught by Graham, such that coupling the valve to the first notch results in a first extension length of the dilator beyond the distal terminus of the catheter (end (53) of Lepulu), and coupling to the second notch results in a second extension length, as such modifications would have been predictable, namely, allow the operator to select between different predefined depths using positive mechanical coupling, thereby improving precision, repeatability, and safety during vascular access by reducing the risk of over-or-under insertion (Figures 5-6 and Paragraphs [0047]-[0048] of Graham). The combination yields predictable results: Lepulu already contemplates variable dilator extension lengths beyond the distal terminus, and Graham’s multiple groove/notch features simply provide a mechanical way to achieve and lock those different lengths with positive engagement, enhancing control without introducing unexpected difficulties.
Regarding claim 31, modified Lepulu teaches, wherein the second length is greater than the first length (Paragraph [0045] of Graham, “the elongate member 40 and/or the inside or outside of the flexible tubular member 54 could be coated, roughened or include small teeth, bumps or grooves to enhance engagement between the components.” Where “grooves” is plural indicating multiple notches. As such, different locking points produce different extension lengths, allowing for the second length to be greater than the first length).
Regarding claim 32, Lepulu teaches, wherein the dilator (dilator (67)) includes a proximal body region having a first flexibility profile (Figure 1, main extruded shaft of dilator (67) which includes proximal hub (70); Col. 6, line 20-42, “… the tapered dilator 67 is made of extruded polyurethane with a radiopaque filler …,” where it would be stiffer for pushability/control) and a distal body region having a second flexibility profile (Figure 1, tapered distal tip (69); Thinner geometry so inherently more flexible/less stiff for atraumatic entry) greater than the first flexibility profile (tapered distal tip (69) is indeed softer/more compliant/greater flexibility than the uniform main shaft).
Lepulu fails to teach, wherein the notch is positioned at least partially between the proximal body region and the distal body region.
Graham teaches, the dilator (elongate member (40)) can include grooves/notches to provide engagement with the tether (flexible member (54)) (Paragraph [0045]; The placement of grooves/notches is not limited to any particular region and is capable of being positioned wherever enhanced grip or positional locking is desired along the elongate member).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to position one or more of the notches/grooves taught by Graham on the dilator of Lepulu at a location at least partially between the proximal body region and the distal body region, as both reference 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 position one or more of the notches/grooves taught by Graham on the dilator of Lepulu at a location at least partially between the proximal body region and the distal body region, as such modifications would have been predictable, namely, enhance positional locking (Paragraph [0047] of Graham). The combination yields predictable results: Lepulu’s dilator already had a proximal stiff region and distal flexible region with the notch simply added as an engagement feature in an intermediate location, enhancing positional locking without altering the intended flexibility gradient or causing unexpected technical issues.
Regarding claim 33, Lepulu further teaches, wherein the dilator (dilator (67)) has a varying durometer at least partially along the longitudinal axis (Inherent from “extruded polyurethane” where main shaft has a higher durometer for stiffness while tapered tip has low durometer for softness/atraumatic).
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771