DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Response to Amendment This office action is responsive to the preliminary amendment filed on November 22, 2023 . As directed by the amendment: claims 6-7, 10, 17-19, 22, 24, and 28 have been amended, no claims have been added, no claims have been canceled. Thus claims 1-28 are presently pending. Applicant’s amendment to the Specification , including amendments to the Abstract, has been entered in the original disclosure, as no substantial information has been added to the specification . Information Disclosure Statement The information disclosure statement (IDS) submitted on January 2, 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claims 8-9 are objected to because of the following informalities: Claim 8 recites “the aspiration catheter is 5-8F”, should read “the aspiration catheter has a diameter of 5-8 French” for clarity of the dimension and its units. Claim 9 recites “the aspiration catheter is 6-8F”, should read “the aspiration catheter has a diameter of 6-8 French” for clarity of the dimension and its units. Appropriate correction is required. 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 appl icant regards as his invention. Claim s 1-2 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the limitation " the internal support " in line 13 . There is insufficient antecedent basis for this limitation in the claim. Claim 1 instead defines an internal guide. For examining purposes, “the internal support” is interpreted to be dependent on the internal guide. Claims 2-23 are dependent from claim 1, and therefore are similarly rejected. Claim 23 recites the limitation "the expandable ring". There is insufficient antecedent basis for this limitation in the claim. The expandable ring is first defined in claim 22, however claim 23 depend from claim 20. Therefore, for examining purposes, claim 23 is interpreted to depend from claim 22. Claim 24 recites the limitation "the internal guide" in at least lines 2, 3, 5, and 10 . There is insufficient antecedent basis for this limitation in the claim. Claim 24 instead defines an internal support earlier in the claim . For examining purposes, “the internal guide ” is interpreted to be dependent on the internal support . Claims 25-27 are dependent from claim 24 , and therefore are similarly rejected. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim s 1 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Anderson et al. (US 20200246586), hereinafter Anderson. Regarding claim 1, Anderson discloses a system for introducing a catheter into the vasculature through a vessel opening (VO) (Figs. 43-4 4 and [0102], system for introducing catheter 1010 into patient's vasculature) comprising: a catheter (introducer catheter 1010) having an internal diameter and external diameter (Fig. 43, catheter 1010 has an external diameter and is shown with an internal lumen thus defining an internal diameter); an internal guide sized for telescopic movement within the catheter (Figs. 43-49, internal dilator 1402 which can move telescopically through catheter 1010), the internal guide for supporting the catheter and protecting a distal tip of the catheter as the catheter is introduced through a VO (Fig. 43 and [0102], dilator 1402 configured to support and protect distal tip 1014 of catheter 1010 during insertion/advancement of the catheter 1010 through the vasculature), the internal guide having: a tapered distal tip for introducing the system through the VO (Fig. 43, dilator 1402 has a tapered distal tip) ; and, a protective cover connected to the tapered distal tip extending proximally for engagement over the distal tip of the catheter (Fig. 43, retention elements 1404 extending proximally from tapered tip of dilator 1402 to protect catheter distal tip 1014), the protective cover moveable between an engaged position over the catheter (Fig. 43, engaged position of elements 1404) and a disengaged position (Fig 44, disengaged position of elements 1404); wherein selective movement of the internal guide relative to the catheter causes the protective cover to move from the engaged position to the disengaged position and when in the disengaged position allows the internal support and protective cover to be proximally withdrawn through the catheter (Fig. 44 and [0102], movement of dilator 1402 causes elements 1404 to move from engaged position (Fig. 43) to disengaged position (Fig. 44) which allows for the dilator 1402 and elements 1404 to be withdrawn through catheter 1010) . Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim s 2-4 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20200246586) . Regarding claim 2, Anderson discloses the system as in claim 1 wherein the protective cover is a plurality of inwardly biased arms (Fig. 43 and [0102], elements 1404 are elastic and inwardly biased arms) . Anderson does not explicitly disclose in the embodiment of Figs. 43-44 the internal guide includes corresponding recesses for receiving the arms in a compressed position . However, an additional embodiment of Anderson discloses t he internal guide includes corresponding recesses for receiving the arms in a compressed position (Fig. 48-49 and [0105], body of dilator 1402 comprises a recessed area proximate to the distal edge of ramp 1410, wherein the recessed areas receive the elements 1404 when in the disengaged/compressed position). I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 43-44 to include t he internal guide having corresponding recesses for receiving the arms in a compressed position . As doing so aids in the insertion/withdrawal of the dilator from the catheter (Anderson, [0104]) . Regarding claim 3, Anderson discloses the system as in claim 1 . Anderson does not explicitly disclose in the embodiment of Figs. 43-44 wherein the protective cover is an elastic sheath circumferentially covering the distal tip of the catheter in the engaged position . However, an additional embodiment of Anderson discloses wherein the protective cover is an elastic sheath circumferentially covering the distal tip of the catheter in the engaged position . (Figs. 45-46 and [0103], elements 1404 are surrounded by a cover 1405 thus forming an elastic sheath which covers catheter distal end 1014) . I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 43-44 to include wherein the protective cover is an elastic sheath circumferentially covering the distal tip of the catheter in the engaged position . Doing so would provide a protective cover which covers the entire distal end of the catheter (Anderson, [0103]). Regarding claim 4, Anderson further discloses in the embodiment of Figs. 45-46 the system as in claim 3 , wherein the elastic sheath seats against the internal guide in the disengaged position (Fig. 46, cover 1405/elements 1404 are seated against dilator 1402 body when in the disengaged position). As d oing so would provide a protective cover which covers the entire distal end of the catheter (Anderson, [0103]). Regarding claim 17, Anderson discloses the system as in claim 1 where the protective cover overlaps the catheter when in the engaged position (Fig. 43, retention elements 1404 overlaps with the distal tip 1014 of catheter 1010 when in engaged position) . However, Anderson does not expressly disclose wherein the overlap length is in a range of 1-5 cm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device Anderson, to have an overlap region length in a range of 1-5 cm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Anderson would not operate differently with the overlap length range and Anderson shows in Fig. 43 and [0102] that a small overlap region exists along the length of the catheter in order to retain the distal end 1014 of the catheter in its collapsed state during advancement of the catheter and dilator through the vasculature. Therefore, the device would function appropriately having the claimed length range. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the overlap distance/length is "preferably" within the claimed ranges (instant specification [0089]). Regarding claim 18, Anderson discloses the system as in claim 1 . Anderson does not explicitly disclose in the embodiment of Figs. 43-44 where the protective cover is connected to the tapered distal tip at a position where the outer diameter of the tapered distal tip is less than the maximum outer diameter of the internal guide . However, an additional embodiment of Anderson discloses where the protective cover is connected to the tapered distal tip at a position where the outer diameter of the tapered distal tip is less than the maximum outer diameter of the internal guide (Fig. 48-49, retention elements 1404 connect to tapered tip of dilator 1402 a position wherein the diameter of the tapered tip is less than the maximum diameter of the dilator, located at the thickest height of ramp 1410) . I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 43-44 to modify the protective cover to be connected to the tapered distal tip at a position where the outer diameter of the tapered distal tip is less than the maximum outer diameter of the internal guide . Doing so aids in the insertion/withdrawal of the dilator from the catheter (Anderson, [0104]). Claim s 5-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20200246586), in view of Tebbutt (WO 2006087512). Regarding claim 5 , Anderson discloses the system as in claim 3 . Anderson fails to disclose wherein the elastic sheath inverts to the disengaged position during withdrawal of the internal guide . However, Tebbutt discloses wherein the elastic sheath inverts to the disengaged position during withdrawal of the internal guide (Fig. 2-3 and pg. 5, para. 2, collar 36 is an elastic sheath which inverts to disengaged position (Fig. 3) during withdrawal of dilator 2) . I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson to incorporate the disclosures of Tebbutt and modify the elastic sheath to invert t o the disengaged position during withdrawal of the internal guide . Doing so would allow for the collar of the dilator to transition to its disengaged position and be withdrawn from the tube in one simple movement (Tebbu t t, pg. 5, para. 2). Regarding claim 6 , Anderson discloses the system as in claim 1. Anderson fails to disclose wherein the catheter has a catheter end stop and the internal guide has an internal guide end stop and wherein when the protective cover is in the engaged position, movement of the internal guide end stop towards the catheter end stop causes the protective cover to move to the disengaged position . However, Tebbutt discloses wherein the catheter has a catheter end stop (Fig. 2-4, patient end surface 10 of tube 1) and the internal guide has an internal guide end stop (Fig. 2-3, dilator 2 has recess end 29) and wherein when the protective cover is in the engaged position, movement of the internal guide end stop towards the catheter end stop causes the protective cover to move to the disengaged position (Fig. 2-3 and pg. 5, para. 2, when collar 36 is in engaged position (Fig. 2), movement of recess end 29 to the patient end surface 10 moves the collar 36 to disengaged position (Fig. 3)) . I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson to incorporate the disclosures of Tebbutt and modify the catheter to have a catheter end stop and modify the internal guide to have an internal guide end stop , such that when the protective cover is in the engaged position, movement of the internal guide end stop towards the catheter end stop causes the protective cover to move to the disengaged position . Doing so would allow for the collar of the dilator to transition to its disengaged position and be withdrawn from the tube in one simple movement (Tebbu t t, pg. 5, para. 2). Regarding claim 10 , Anderson discloses the system as in claim 1. Anderson fails to disclose where the internal guide is hollow, and the tapered distal tip includes a through bore allowing the internal guide to ride over a wire. However, Tebbutt discloses where the internal guide is hollow (Fig. 2-3, dilator 2 is hollow), and the tapered distal tip includes a through bore allowing the internal guide to ride over a wire (Fig. 2-3 and pg. 4, para. 2, dilator 2 bore 22 extending to distal tip 25 and configured to ride over a wire). I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson to incorporate the disclosures of Tebbutt and modify the internal guide to be hollow and the tapered distal tip to include a through bore allowing the internal guide to ride over a wire . Doing so allows for the dilation and tube assembly to be inserted into the patient over the guidewire for delivery to the target location within the body (Tebbutt, pg. 4, para. 2) . Claim s 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20200246586), in view of Dinh et al. (US 20130253417), hereinafter Dinh. Regarding claim 7 , Anderson discloses the system as in claim 1. Anderson fails to disclose where the catheter is an aspiration catheter having a soft distal tip region and a length sufficient to extend from a radial artery VO to the cerebral vessels for the treatment of ischemic stroke. However, Dinh discloses where the catheter is an aspiration catheter (Fig. 1 and [0038], catheter 100 is an aspiration catheter) having a soft distal tip region (Fig. 1 and [0092], catheter 100 has a distal tip which is flexible, and therefore soft) and a length sufficient to extend from a radial artery VO to the cerebral vessels for the treatment of ischemic stroke (Fig. 1 and [0003, 0008-0009, 0014, 0082], catheter 100 is configured with a length sufficient to extend from an incision in a radial artery to the target cerebral vessels for treatment of ischemic stroke). I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson to incorporate the disclosures of Dinh and modify the catheter to be an aspiration catheter having a soft distal tip region and a length sufficient to extend from a radial artery VO to the cerebral vessels for the treatment of ischemic stroke. Doing so would provide a catheter that is sized and configured for delivery to the cerebral vessels and preform aspiration to restore flow through or around an obstruction, thus treating or preventing ischemic stroke (Dinh, [0006, 0014-0015]). Regarding claim 8 , Anderson, in view of Dinh, discloses the system as in claim 7 , as explained above. As noted above Anderson fails to disclose an aspiration catheter, and is thus silent to where the aspiration catheter is 5-8F . However, Dinh further discloses where the aspiration catheter is 5-8F ([0036,0062-0065], catheter can be one of 5-8F, for example 7F). I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Dinh, to further incorporate the disclosures of Dinh and modify the aspiration catheter to be 5-8F. Doing so would provide a catheter that is sized and configured for delivery to the cerebral vessels and preform aspiration to restore flow through or around an obstruction, thus treating or preventing ischemic stroke (Dinh, [0006, 0014-0015]). Regarding claim 9 , Anderson, in view of Dinh, discloses the system as in claim 7 , as explained above. As noted above Anderson fails to disclose an aspiration catheter, and is thus silent to where the aspiration catheter is 6 -8F . However, Dinh further discloses where the aspiration catheter is 6 -8F ([0036,0062-0065], catheter can be one of 6 -8F, for example 7F). I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Dinh, to further incorporate the disclosures of Dinh and modify the aspiration catheter to be 6-8F. Doing so would provide a catheter that is sized and configured for delivery to the cerebral vessels and preform aspiration to restore flow through or around an obstruction, thus treating or preventing ischemic stroke (Dinh, [0006, 0014-0015]). Claims 11-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20200246586), in view of Tebbutt (WO 2006087512) and Montgomery (US 0724913) . Regarding claim 11, Anderson discloses system as in claim 1 . Anderson does not explicitly disclose in the embodiment of Figs. 43-44 wherein the protective cover is a sheath . However, an additional embodiment of Anderson discloses wherein the protective cover is a sheath (Figs. 45-46 and [0103], elements 1404 are surrounded by a cover 1405 thus forming an elastic sheath which covers catheter distal end 1014) . I t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig. 43-44 to include wherein the protective cover is a sheath . Doing so would provide a protective cover which covers the entire distal end of the catheter (Anderson, [0103]). Anderson fails to disclose the sheath inverts to the disengaged position during withdrawal of the internal guide. However, Tebbutt discloses the sheath inverts to the disengaged position during withdrawal of the internal guide (Fig. 2-3 and pg. 5, para. 2, collar 36 is an elastic sheath which inverts to disengaged position (Fig. 3) during withdrawal of dilator 2) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson to incorporate the disclosures of Tebbutt and modify the sheath to invert to the disengaged position during withdrawal of the internal guide. Doing so would allow for the collar of the dilator to transition to its disengaged position and be withdrawn from the tube in one simple movement (Tebbutt, pg. 5, para. 2). Anderson, in view of Tebbutt, fails to disclose where the sheath has at least one slit extending along a longitudinal length of the sheath, the slit for relieving friction between the catheter and the internal guide. However, Montgomery discloses where the sheath has at least one slit extending along a longitudinal length of the sheath (Fig. 1-2, sheath 5 comprises slit grooves 10 extending the longitudinal length of sheath), the slit for relieving friction between the catheter and the internal guide (Figs. 4-5 and pg. 2, lns: 1-6, slits allow for more compact folding to allow for ease of movement/introduction, therefore relieving friction). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Tebbutt, to incorporate the disclosures of Montgomery and modify the sheath to comprise at least one slit extending along a longitudinal length of the sheath, the slit for relieving friction between the catheter and the internal guide. Doing so allows for the sheath to fold in a smaller compact position and be more readily introduced/removed, without impairing its function (Montgomery, pg. 2, lns: 3-6). Regarding claim 12, Anderson, in view of Tebbutt and Montgomery, discloses the system as in claim 11, as explained above. As noted above Anderson and Tebbutt fails to disclose the at least one slit, and is thus silent to where the at least one slit extends to a proximal edge of the sheath. However, Montgomery further discloses where the at least one slit extends to a proximal edge of the sheath (Figs. 1-2, slit grooves 10 extend to the proximal end of sheath 5, wherein the sheath 5 meets the neck 7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Tebbutt and Montgomery, to further incorporate the disclosures of Montgomery and modify the at least one slit to extend to a proximal edge of the sheath. Doing so would allow for the sheath to fold in a smaller compact position and be more readily introduced/removed, without impairing its function (Montgomery, pg. 2, lns: 3-6). Regarding claim 13, Anderson, in view of Tebbutt and Montgomery, discloses the system as in claim 12, as explained above. As noted above Anderson and Tebbutt fails to disclose the at least one slit, and is thus silent to where the at least one slit includes a zone of weakness capable of opening during inversion. However, Montgomery further discloses where the at least one slit includes a zone of weakness capable of opening during inversion (Figs. 1-2 and pg. 1, ln: 102-pg. 2, ln: 6, slit grooves 10 are thinned sheath material thus forming zones of weakness which may flex open wider/contract on themselves during movement and inversion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Tebbutt and Montgomery, to further incorporate the disclosures of Montgomery and modify the at least one slit to include a zone of weakness capable of opening during inversion. Doing so would allow for the sheath to fold in a smaller compact position and be more readily introduced/removed, without impairing its function (Montgomery, pg. 2, lns: 3-6). Regarding claim 14, Anderson, in view of Tebbutt and Montgomery, discloses the system as in claim 11, as explained above. As noted above Anderson and Tebbutt fails to disclose the at least one slit, and is thus silent to where the at least one slit does not extend across a proximal edge of the sheath. However, Montgomery further discloses where the at least one slit does not extend across a proximal edge of the sheath (Figs. 1-2, slit grooves 10 extend to the proximal end of sheath 5, wherein the sheath 5 meets the neck 7, but not through the proximal end and into neck 7). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Tebbutt and Montgomery, to further incorporate the disclosures of Montgomery and modify the at least one slit such that it does not extend across a proximal edge of the sheath. Doing so would allow for the sheath to fold in a smaller compact position and be more readily introduced/removed, without impairing its function (Montgomery, pg. 2, lns: 3-6). Regarding claim 15, Anderson, in view of Tebbutt and Montgomery, discloses the system as in claim 11, as explained above. As noted above Anderson and Tebbutt fails to disclose the at least one slit, and is thus silent to where the at least one slit is a longitudinal slot. However, Montgomery further discloses where the at least one slit is a longitudinal slot (Figs. 1-2, slit grooves 10 form a longitudinal slot on the surface of sheath 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Tebbutt and Montgomery, to further incorporate the disclosures of Montgomery and modify the at least one slit to be a longitudinal slot. Doing so would allow for the sheath to fold in a smaller compact position and be more readily introduced/removed, without impairing its function (Montgomery, pg. 2, lns: 3-6). Regarding claim 16, Anderson, in view of Tebbutt and Montgomery, discloses the system as in claim 11, as explained above. As noted above Anderson and Tebbutt fails to disclose the at least one slit, and is thus silent to where the sheath includes one or more voids to reduce the total volume of the sheath and facilitate sheath inversion during withdrawal of the internal guide. However, Montgomery further discloses where the sheath includes one or more voids to reduce the total volume of the sheath and facilitate sheath inversion during withdrawal of the internal guide (Figs. 1-2 and pg. 2, lns: 1- 6, slit grooves 10 form voids which reduce the total volume of the sheath 5, thus allowing sheath to fold up smaller and be more easily introduced/removed). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Tebbutt and Montgomery, to further incorporate the disclosures of Montgomery and modify the sheath to include one or more voids to reduce the total volume of the sheath and facilitate sheath inversion during withdrawal of the internal guide. Doing so would allow for the sheath to fold in a smaller compact position and be more readily introduced/removed, without impairing its function (Montgomery, pg. 2, lns: 3-6). Regarding claim 19 and Anderson, in view of Tebbutt and Montgomery, Anderson further discloses in the embodiment of Fig. 45-46 the system as in claim 11 further comprising a band surrounding the distal end of the sheath for holding the sheath on the catheter prior to use (Figs. 45-46 and [0102-0103], the elements 1404 of sheath form bands which together surround the distal end of the sheath covering 1405, and are configured to hold and protect the distal tip 1014 of catheter 1010 before use. Examiner note: Merriam-Webster online dictionary defines "band" as "a strip serving to join or hold things together", therefore the elements 1404 meet the limitation as they serve to hold the covering 1405 to the distal tip 1014). As doing so would provide an effective sheath configuration which covers the entire distal end of the catheter (Anderson, [0103]). Regarding claim 20 and Anderson, in view of Tebbutt and Montgomery, Anderson further discloses embodiment of Fig. 45-46 the system as in claim 11 wherein a proximal edge of the protective cover includes a shaped band for applying a biasing force over the catheter to hold the protective cover in an engaged position on the catheter (Figs. 45-46 and [0102-0103], the elements 1404 of sheath are linear bands which extend to the proximal end of the sheath covering 1405, and apply a biasing force over the catheter tip 1014 to hold themselves and cover 1405 in the engaged position on catheter 1010. Examiner note: Merriam-Webster online dictionary defines "band" as "a strip serving to join or hold things together", therefore the elements 1404 meet the limitation as they serve to hold the covering 1405 to/against the distal tip 1014). As doing so would provide an effective sheath configuration which covers the entire distal end of the catheter (Anderson, [0103]). Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20200246586), in view of Tebbutt (WO 2006087512) and Montgomery (US 0724913), as applied to claim 20 above, and further in view of Mathena et al. (US 20180132837) , hereinafter Mathena . Regarding claim 21, Anderson, in view of Tebbutt and Montgomery, discloses the system as in claim 20. Anderson, in view of Tebbutt and Montgomery, fails to disclose wherein the shaped band is a thermo material and wherein exposure to a body temperature relaxes the biasing force. However, Mathena discloses wherein the shaped band is a thermo material and wherein exposure to a body temperature relaxes the biasing force (Fig. 4 and [0047], sheath body includes an elastic thermo material, such as nitinol wire (which is an equivalent to the elastic materials disclosed in [0086] of Anderson), wherein the nitinol transitions the wire to its default/relaxed shape when warmed to the body temperature of the patient, which may be configured to relieve the biasing force) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Tebbutt and Montgomery, to incorporate the disclosures of Mathena and modify the shaped band to be a thermo material and wherein exposure to a body temperature relaxes the biasing force. Doing so would allow the device to have a first shape at room temperature which facilitates insertion to the desired location in the body, then allows the device to transition its default shape after insertion/placement when the device is warmed to the body temperature (Mathena [0047]). Claim s 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20200246586), in view of Fukuoka et al. (US 20150265802), hereinafter Fukuoka. Regarding claim 2 2 , Anderson discloses the system as in claim 3 . Anderson fails to disclose an expandable ring, the expandable ring having an internal diameter expandable between an external diameter of the internal support and an external diameter of the catheter, the expandable ring having a distal edge having a thickness to be placed under a proximal edge of the elastic sheath during assembly of the elastic sheath on the catheter. However, Fukuoka discloses an expandable ring (Fig. 10, ring 110, with expanding portion 112), the expandable ring having an internal diameter expandable between an external diameter of the internal support and an external diameter of the catheter (Fig. 10-11 and [0076,0081], expanding portion 112 internal diameter may expand between expanded state which allows catheter 40 to advance and collapsed state which blocks catheter 40 from passing but permits guide 40), the expandable ring having a distal edge having a thickness to be placed under a proximal edge of the elastic sheath during assembly of the elastic sheath on the catheter (Fig. 6, 10 and [0082], distal portion 112 is sized to be assembled under protective cover 80). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson to incorporate the disclosures of Fukuoka and modify the device to comprise an expandable ring, the expandable ring having an internal diameter expandable between an external diameter of the internal support and an external diameter of the catheter, the expandable ring having a distal edge having a thickness to be placed under a proximal edge of the elastic sheath during assembly of the elastic sheath on the catheter . Doing so would enable the distal end of the catheter to reduce its diameter in order me assembled and maintained under the protective cover (Fukuoka, [0082]) . Regarding claim 2 3 , as best understood with 35 U.S.C, 112(b) issue above, Anderson , in view of Fukuoka, discloses system as in claim 2 2, as explained above. As noted above, Anderson does not disclose the expandable ring, and is thus silent to where the expandable ring is openable . However, Fukuoka further discloses where the expandable ring is openable (Fig. 10-11, expandable ring 110 is openable via the unscrewing of outer member 120) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson , in view of Fukuoka, to further incorporate the disclosures of Fukuoka and modify the device the expandable ring to be openable. Doing so would enable the distal end of the catheter to reduce its diameter in order me assembled and maintained under the protective cover (Fukuoka, [0082]) . Claim s 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20200246586), in view of Mackenzie et al. (US 20010012946 ), hereinafter Mackenzie. Regarding claim 24, Anderson discloses a kit (Fig. 43-49, kit comprising catheter system 1010) comprising: an internal support (Figs. 43- 44 , internal dilator 1402) , the internal guide sized for telescopic movement within a catheter (Figs. 43- 44 , internal dilator 1402 sized to move telescopically through catheter 1010) , the internal guide for supporting the catheter and protecting a distal tip of the catheter as the catheter is introduced through a vessel opening (VO) (Fig. 43 and [0102], dilator 1402 configured to support and protect distal tip 1014 of catheter 1010 during insertion/advancement of the catheter 1010 through the vasculature) , the internal guide having: a tapered distal tip for introducing the system through the VO (Fig. 43 and [0102], dilator 1402 has a tapered distal tip for advancement through vasculature) ; and, a protective cover connected to the tapered distal tip extending proximally for engagement over the distal tip of the catheter (Fig. 43, retention elements 1404 extending proximally from tapered tip of dilator 1402 to protect catheter distal tip 1014) , the protective cover moveable between an engaged position over the catheter (Fig. 43, engaged position of elements 1404) and a disengaged position (Fig 44, disengaged position of elements 1404) ; wherein selective movement of the internal guide relative to the catheter causes the protective cover to move from the engaged position to the disengaged position and when in the disengaged position allows the internal support and protective cover to be proximally withdrawn through the catheter (Fig. 44 and [0102], movement of dilator 1402 causes elements 1404 to move from engaged position (Fig. 43) to disengaged position (Fig. 44) which allows for the dilator 1402 and elements 1404 to be withdrawn through catheter 1010) . Anderson fails to disclose the internal support within sterilized packaging. However, Mackenzie discloses the internal support within sterilized packaging (Fig. 7 and [0037], catheter kit components, including dilator 14 may be packaged in sterilized packaging P). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson to incorporate the disclosures of Mackenzie and modify the kit to comprise the internal support within sterilized packaging. Doing so would maintain the component's sterility prior to use (Mackenzie, [0037]). Regarding claim 25, Anderson, in view of Mackenzie, discloses the kit as in claim 24 further comprising the catheter (Fig, 43 catheter 1010). As noted above, Anderson does not disclose the sterilized packaging, and is thus silent to wherein the internal support and catheter are packaged within the same sterilized packaging. However, Mackenzie further discloses wherein the internal support and catheter are packaged within the same sterilized packaging (Fig. 7 and [0037], kit components including catheter 50 and dilator 14 may be packaged together in sterile packaging). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Mackenzie, to further incorporate the disclosures of Mackenzie and modify the kit to comprise the internal support and catheter packaged within the same sterilized packaging. Doing so would maintain the components' sterility prior to use (Mackenzie, [0037]). Regarding claim 26, Anderson, in view of Mackenzie, discloses the kit as in claim 24 further comprising the catheter (Fig, 43 catheter 1010). As noted above, Anderson does not disclose the sterilized packaging, and is thus silent to wherein the catheter and the internal support are in separate packages including a catheter package and an internal support package. However, Mackenzie further discloses wherein the catheter and the internal support are in separate packages including a catheter package and an internal support package (Fig. 7 and [0037], individual kit components including catheter 50 and dilator 14 may be packaged in separate sterile packaging, then placed in a common kit packaging). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Mackenzie, to further incorporate the disclosures of Mackenzie and modify the kit to comprise the internal support and catheter in separate sterilized packaging including a catheter package and an internal support package. Doing so would maintain each component's sterility prior to use (Mackenzie, [0037]). Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20200246586), in view of Mackenzie (US 20010012946 ), as applied to claim 24 above, and further in view of Fukuoka (US 20150265802) . Regarding claim 2 7 , Anderson , in view of Mackenzie, discloses the kit as in claim 24 . Anderson , in view of Mackenzie, fails to disclose an expandable ring within the internal support package, the expandable ring having an internal diameter expandable between an external diameter of the internal support and an external diameter of the catheter, the expandable ring having a distal edge having a thickness to be placed under a proximal edge of the protective cover during assembly of the protective cover on the catheter. However, Fukuoka discloses an expandable ring within the internal support package (Fig. 10, ring 110, with expanding portion 112, which couples to the protective cover 80 (Fig. 6)), the expandable ring having an internal diameter expandable between an external diameter of the internal support and an external diameter of the catheter (Fig. 10-11 and [0076,0081], expanding portion 112 internal diameter may expand between expanded state which allows catheter 40 to advance and collapsed state which blocks catheter 40 from passing but permits guide 40), the expandable ring having a distal edge having a thickness to be placed under a proximal edge of the protective cover during assembly of the protective cover on the catheter (Fig. 6, 10 and [0082], distal portion 112 is sized to be assembled under protective cover 80). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson , in view of Mackenzie, to incorporate the disclosures of Fukuoka and modify the device to comprise an expandable ring within the internal support package, the expandable ring having an internal diameter expandable between an external diameter of the internal support and an external diameter of the catheter, the expandable ring having a distal edge having a thickness to be placed under a proximal edge of the protective cover during assembly of the protective cover on the catheter . Doing so would enable the distal end of the catheter to reduce its diameter in order me assembled and maintained under the protective cover (Fukuoka, [0082]) . Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 20200246586), in view of Mackenzie (US 20010012946 ) and Tebbutt (WO 2006087512) . Regarding claim 28, Anderson discloses a method of introducing a catheter into a vessel through a vessel opening (VO) (Figs. 43-4 4 and [0102], method for introducing catheter 1010 into patient's vasculature through a vessel opening) comprising the steps of: d) introducing an arterial access assembly of an internal guide having a tapered proximal tip and a catheter supported over the internal guide (Fig. 43 and [0066, 0084, 0102], a catheter assembly comprising dilator 1402, having a tapered tip, and a catheter 1010 supported over the dilator 1402 is introduced into the vessel), the catheter having a distal tip operatively engaged with a protective cover configured to the internal guide (Fig. 43, catheter distal tip 1404 is engaged with retention elements 1404 of dilator 1402); e) advancing the assembly away from the VO ([0102], assembly is advanced together through the vasculature and therefore away from the vessel opening); and, g) withdrawing the internal guide and protective cover through the catheter (Fig. 44 and [0102], dilator 1402 and its retention elements 1404 are withdrawn through the catheter 1010). Anderson fails to disclose a) puncturing a vessel with a hollow needle to form a VO; b) introducing a wire through the hollow needle; c) withdrawing the needle over the wire. However, Mackenzie discloses a) puncturing a vessel with a hollow needle to form a VO (Fig. 2A and [0030], needle N forms a tissue tract into a blood vessel) ; b) introducing a wire through the hollow needle (Figs. 2A-B and [0030], guidewire GW is placed through needle N and into the blood vessel); c) withdrawing the needle over the wire (Fig. 2B and [0030], needle N is withdrawn over guidewire GW). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson to incorporate the disclosures of Mackenzie and modify the method to include a) puncturing a vessel with a hollow needle to form a VO; b) introducing a wire through the hollow needle; c) withdrawing the needle over the wire. Doing so would provide reliable access to a target blood vessel which allows a dilator/catheter to enter the vessel though an original needle penetration, while minimizing damage to surrounding tissue (Mackenzie, [0004,0011]). Anderson, in view of Mackenzie, fails to disclose f) advancing the internal guide proximally relative to the catheter to disengage the protective cover from the distal tip of the catheter. However, Tebbutt discloses f) advancing the internal guide proximally relative to the catheter to disengage the protective cover from the distal tip of the catheter (Fig. 2-3 and pg. 5, para. 2, proximal movement of dilator 2 relative to catheter tube 1 causes collar 36 to disengage from distal tip of catheter tube 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Anderson, in view of Mackenzie, to incorporate the disclosures of Tebbutt and modify the method to include advancing the internal guide proximally relative to the catheter to disengage the protective cover from the distal tip of the catheter. Doing so would allow for the collar of the dilator to transition to its disengaged position and be withdrawn from the tube in one simple movement (Tebbutt, pg. 5, para. 2). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SARAH D GRASMEDER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0258 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8 am-5 pm EST . 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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. /SARAH DYMPNA GRASMEDER/ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783